[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spinal-cord-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spinal-cord-diseases":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,56,90,117,146,166,202,233,254,324,356,385,410,429],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":37,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100644654","impact-of-transcutaneous-spinal-stimulation-on-blood-pressure-and-orthostasis-in-spinal-cord-injury-100644654",false,"NCT07674511","Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury","Impact of Transcutaneous Spinal Stimulation on Blood Pressure and Orthostasis in Spinal Cord Injury: Short and Long-Term Effects","(SCI)","Inclusion Criteria:\n\n* Individuals with a SCI ≥ 1 year after injury\n* Injury level ≥ T6 (thoracic level)\n* AIS grade A-C\n* Cardiovascular dysfunction characterized by one or more of the following:\n\n  1. Persistent hypotension (SBP \\\u003C 90mmHg)\n  2. Orthostatic hypotension (OH, a drop of 20\u002F10 mmHg in SBP\u002FDBP within 5 minutes of standing\u002Fupright positioning).\n\nAdditionally, experiencing orthostatic symptoms in daily life and\u002For requiring medication to manage OH.\n\nExclusion Criteria:\n\n* Current illness (e.g., infection, a pressure injury that might interfere with the intervention)\n* Ventilator-dependent\n* History of implanted brain\u002Fspine\u002Fnerve stimulators\n* Cardiac pacemaker\u002Fdefibrillator or intra-cardiac lines\n* Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction\n* History of seizures\n* pregnancy\n* Insufficient mental capacity to understand and independently provide consent\n* Deemed unsuitable by the study physician","ALL","18 Years","75 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to learn whether stimulation applied to the spinal cord through the skin (called transcutaneous spinal stimulation) can help control blood pressure in people with a spinal cord injury.\n\nThe main questions this study attempts to solve:\n\n1. What are the immediate effects of spinal cord transcutaneous stimulation on BP?\n2. Does stimulation produce lasting improvements in BP regulation and subsequently, daily function?",[28,29,30,31,32,33,34,35,36],"Spinal Cord Injuries","Hypotension","Orthostatic Hypotension","Spinal Cord Diseases","Cardiovascular Diseases","Trauma, Nervous System","Central Nervous System Disease","Nervous System Diseases","Blood Pressure",[38,39,40,41,42],"transcutaneous spinal cord stimulation","spinal stimulations","orthostatic hypotension","blood pressure","neuromodulation","NOT_YET_RECRUITING","2026-06-24",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":22},"2026-09",{"date":51,"type":22},"2028-12",{"name":53,"class":54},"Kessler Foundation","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":55},"100441087","laser-interstitial-thermal-ablation-and-stereotactic-radiosurgery-for-patients-with-spine-metastases-100441087","NCT05023772","Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases","A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases","Inclusion Criteria:\n\n* Age \\> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)\n* Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.\n* Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.\n* The vertebral body site to be treated must be located from T2 to L1\n* No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.\n* Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).\n* ECOG performance status \\\u003C2 or Karnofsky performance status (KPS) \\>50\n* Life expectancy \\>3 months.\n* Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Requires open spinal procedure or a percutaneous procedure without the use of image guidance.\n* Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.\n* Unable to tolerate general anesthesia and prone position.\n* Unable to undergo MRI scan of the spine.\n* Inability to lie flat on a treatment table for \\>60 minutes.\n* Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)\n* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.\n* Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \\\u003C4\u002F5 in extremity or extremities affected by the level of the spinal cord compression)",{"count":64,"type":22},60,[25],"The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.",[68,31,69,70,71],"Neoplasm Metastasis","Spinal Cord Compression","Spinal Cord Tumor","Spine Metastases",[73,74,75,76,77,78,79],"Laser Ablation","Spinal Cord","Minimally Invasive Surgical Procedure","Stereotactic Radiosurgery","Pain Control","Metastasis","Epidural Tumor","RECRUITING","2026-06-02",{"date":83,"type":47},"2026-06-03",{"date":85,"type":47},"2021-09-02",{"date":87,"type":22},"2028-06-20",{"name":89,"class":54},"Henry Ford Health System",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":55},"100498882","multi-speed-ergonomic-wheelchair-100498882","NCT05776030","Multi-speed Ergonomic Wheelchair","Inclusion Criteria:\n\nInclusion criteria:\n\n* Uses manual wheelchair daily\n* Mass less than 125 kg\n* Age 18 or older\n* Decisional competency to provide consent and cognitive ability to participate fully in study procedures\n* Body size appropriate to fit the wheelchairs (16\" and 18\" seat widths)\n\nExclusion Criteria:\n\nExclusion criteria:\n\n* Sitting surface pressure injuries\n* Flap procedure to address pressure injury less than one year earlier\n* Unable to obtain clinically acceptable seating system for study wheelchairs\n* Not able to propel a manual wheelchair\n* Upper extremity or spine issues which would make this study unsafe, such as recent surgeries, fractures, tendon tears or nerve impingement (will be assessed by SCI physician - Dr. Byron Eddy)\n* Medical conditions such as cardiovascular disease, pulmonary disease, or other conditions that would make the study procedures unsafe (will be assessed by SCI physician - Dr. Byron Eddy)",{"count":97,"type":22},30,[25],"Over one million Americans rely on their upper extremities for manual wheelchair propulsion. Shoulder overuse injuries are prevalent among manual wheelchair users and these injuries often result in shoulder pain. Severe shoulder pain can lead some wheelchair users to transition from manual to powered mobility, complicating transportation, and reducing independence in activities of daily living. This project will expand the understanding of a new wheelchair design that allows better positioning of the hand rims and allows for different gearing. The investigators will study steady-state propulsion efficiency with different gear ratios and develop a new system with multiple gear ratios. The advanced gearing will allow for a low gear when initiating movement, going uphill, or when moving over carpet, and then a higher gear option for movements on hard flat level terrain. This system has the potential to dramatically improve shoulder ergonomics and reduce pain in many future manual wheelchair users.",[31,28],[102,103,104,105,106],"Wheelchairs","Community Participation","Social Participation","Ergonomics","Self-Help Devices","2026-04-14",{"date":109,"type":47},"2026-04-20",{"date":111,"type":47},"2024-07-18",{"date":113,"type":22},"2027-03-31",{"name":115,"class":116},"VA Office of Research and Development","FED",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":55},"100495499","spinal-cord-transcutaneous-stimulation-effect-on-blood-pressure-in-acute-spinal-cord-injury-sci-100495499","NCT05731986","Spinal Cord Transcutaneous Stimulation Effect on Blood Pressure in Acute Spinal Cord Injury (SCI)","Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury - A Safety, Feasibility and Efficacy Study","SCI","Inclusion Criteria:\n\n* 7-30 days after injury\n* Injury level ≥T2 (thoracic level)\n* American Spinal Injury Association Impairment Scale (AIS) A-C\n* Exhibits at least one of the following hypotensive symptoms:\n\n  1. Baseline hypotension - resting supine or seated SBP \\\u003C 90mmHg;\n  2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;\n  3. Symptoms of orthostasis with a drop of SBP (\\\u003C90mmHg) from supine to sitting.\n\nExclusion Criteria:\n\n* Current illness (e.g., a recent diagnosis of a deep vein thrombosis (DVT) or pulmonary embolism (PE), a pressure injury that might interfere with the intervention, etc.) or infection\n* Ventilator-dependent\n* History of implanted brain\u002Fspine\u002Fnerve stimulators\n* Cardiac pacemaker\u002Fdefibrillator or intra-cardiac lines\n* Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction\n* Initiated on new cardiac medications within the past 5 days\n* Insufficient mental capacity to understand and independently provide consent\n* Pregnancy\n* Cancer\n* Deemed unsuitable by study physician",{"count":126,"type":22},12,[25],"The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal cord injury (within 30 days of injury). Blood pressure instability, specifically orthostatic hypotension (a drop in blood pressure when moving lying flat on your back to an upright position), appears early after the injury and often significantly interferes with participation in the critical rehabilitation time period.\n\nThe main questions it aims to answer are:\n\n1. Can optimal spinal stimulation increase blood pressure and resolve orthostatic symptoms (such as dizziness and nausea) when individuals undergo an orthostatic provocation (a sit-up test)? Optimal stimulation and sham stimulation (which is similar to a placebo treatment) will be compared.\n2. What are the various spinal sites and stimulation parameters that can be used to increase and stabilize blood pressure to the normal range of 110-120 mmHg?\n\nParticipants will undergo orthostatic tests (lying on a bed that starts out flat and then moved into an upright seated position by raising the head of bed by 90° and dropping the base of the bed by 90° from the knee) with optimal and sham stimulation, and their blood pressure measurements will be evaluated and compared.",[28,31,33,35,130,29,30,32,131,36],"Central Nervous System Diseases","Acute Spinal Cord Injury",[133,134,30,36,135,136,29,137],"Transcutaneous Spinal Cord Stimulation","Spinal stimulation","Neuromodulation","Acute spinal cord injury","Acute inpatient rehabilitation","2025-08-29",{"date":140,"type":47},"2025-09-02",{"date":142,"type":47},"2023-12-01",{"date":144,"type":22},"2026-08",{"name":53,"class":54},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":123,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":55},"100495001","the-effect-of-transcutaneous-stimulation-on-blood-pressure-in-spinal-cord-injury-sci-100495001","NCT05725499","The Effect of Transcutaneous Stimulation on Blood Pressure in Spinal Cord Injury (SCI)","Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury","Inclusion Criteria:\n\n* Spinal cord injury for greater than or equal to 6 months\n* Injury level ≥ T6 (thoracic level)\n* American Spinal Injury Association (ASIA) Impairment Scale (AIS) A-D\n* Exhibits at least one of the following hypotensive symptoms:\n\n  1. Baseline hypotension - resting supine or seated systolic blood pressure(SBP) \\\u003C 90mmHg;\n  2. SBP drop ≥ 20 mmHg within 5 minutes of assuming seated position;\n  3. Symptoms of orthostasis with a drop of SBP (\\\u003C90mmHg) from supine to sitting\n\nExclusion Criteria:\n\n* Current illness (infection, a pressure injury that might interfere with the intervention, a recent diagnosis of DVT\u002FPE, etc.)\n* Ventilator-dependent\n* History of implanted brain\u002Fspine\u002Fnerve stimulators\n* Cardiac pacemaker\u002Fdefibrillator or intra-cardiac lines\n* Significant coronary artery or cardiac conduction disease, a recent history of myocardial infarction\n* Insufficient mental capacity to understand and independently provide consent\n* Pregnancy\n* Cancer\n* Deemed unsuitable by study physician",{"count":154,"type":22},5,[25],"This project will investigate the effect of spinal cord transcutaneous stimulation on blood pressure in individuals with a chronic spinal cord injury who experience blood pressure instability, specifically, orthostatic hypotension (a drop in blood pressure when moving from lying flat on your back to an upright position).\n\nThe main questions it aims to answer are:\n\n1. What are the various spinal sites and stimulation parameters that normalize and stabilize blood pressure during an orthostatic provocation (70 degrees tilt)?\n2. Does training, i.e., exposure to repeated stimulation sessions, have an effect on blood pressure stability?\n\nParticipants will undergo orthostatic tests (lying on a table that starts out flat, then tilts upward up to 70 degrees), with and without stimulation, and changes in their blood pressure will be evaluated.",[28,29,30,31,32,33,130,35,36],[133,159,30,36,135],"Spinal Stimulation",{"date":140,"type":47},{"date":162,"type":47},"2023-02-01",{"date":164,"type":22},"2026-08-01",{"name":53,"class":54},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":173,"sex":17,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":184,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100496444","effects-of-long-term-ventilation-support-on-the-quality-of-life-of-als-patients-and-their-families-100496444","NCT05744310","Effects of Long Term Ventilation Support on the Quality of Life of ALS Patients and Their Families","ALS-LTMV","Inclusion criteria for patients:\n\n1. A clinical diagnosis of probable ALS according to the revised El Escorial criteria\n2. Progression of the illness leading the consulting physician to offer treatment with LTMV\n3. Can communicate in Norwegian\n\nInclusion criteria for partners of ALS patients:\n\n1. Partner of a patient with ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nInclusion criteria for children:\n\n1. Children from 8 years and older having a parent who suffers from ALS with progression of the illness leading the consulting physician to offer treatment with LTMV\n2. Can communicate in Norwegian\n\nExclusion criteria for patients, partners and children of ALS patients:\n\n1\\. Potential participants with cognitive impairment or dementia.",true,"8 Years",{"count":176,"type":22},200,[25],"Amyotrophic lateral sclerosis (ALS) is a serious rapidly progressive disease of the nervous system. The average survival from the time of diagnosis is two to three years. The patient physical and psychological sufferings in ALS are immense, and apart from Riluzole, there is no effective treatment. Care of advanced ALS have an estimated cost of 4-8 million NOK per year. Perhaps the most challenging topic of ALS care is the decision to extend ventilation support into the stages of disease that require treatment both during day and night. In these cases, treatment is clearly life-sustaining and although quality of life may be maintained, the burden of caregiving imposed upon family or health care workers is huge, regardless of tracheostomy (TIV) or non-invasive (NIV) modality.\n\nThe present study is a longitudinal questionnaire study in Norway measuring overall quality of life, health-related quality of life, and disease-specific quality of life in ALS patients, partners and children before and after the introduction of life sustaining ventilation support. The investigators aim to increase the knowledge on how life-sustaining ventilation support with NIV or TIV affects the quality of life in ALS patients, life partners and children. The results from the study may provide crucial information for clinicians and patients on one of the most difficult ethical issues of ALS treatment. The investigators anticipate that this information will facilitate a shared decision making processes, weighing benefits and disadvantages in a wider perspective.",[180,181,35,31,182,183],"Amyotrophic Lateral Sclerosis","Motor Neuron Disease","Neurodegenerative Diseases","TDP-43 Proteinopathies",[185,186,187,188,189,190,191],"Quality of life","Overall quality of life","Health related quality of life","Disease specific quality of life","Ventilation support","Non-invasive ventilation support","Invasive ventilation support","2025-08-22",{"date":194,"type":47},"2025-08-28",{"date":196,"type":47},"2023-04-21",{"date":198,"type":22},"2032-08-21",{"name":200,"class":54},"Haukeland University Hospital",9,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":173,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100600602","optimization-of-adaptive-rowing-seating-100600602","NCT07099625","Optimization of Adaptive Rowing Seating","Optimization of Adaptive Rowing Seating (OARS)","OARS","Inclusion Criteria:\n\n* Non-ventilator dependent paralysis, such as:\n\n  * central nervous system impairment\n  * spinal cord injuries with single neurological level in the cervical to lumbosacral region\n  * cerebrovascular accident with associated sequelae including but not limited to hemiparesis and spasticity\n  * neurodegenerative disorders including but not limited to amyotrophic lateral sclerosis, multiple sclerosis, multiple system atrophy, and parkinsonism\n* Poor trunk control\u002Fstability\n* Ability of body structure to fit within the limits of AIRS and the rowing system\n* Either volitional control of lower extremities or response\u002Ftolerance to electrical stimulation\n* Individuals who would be classified as PR2 or PR1 - FISA Para-Rowing Classifications\n\nExclusion Criteria:\n\n* Veterans will be excluded if they have:\n\n  * acute illness or injury\n  * active or recent pressure injuries in the last 6 months affecting their ability to safely row (e.g., the coccyx, ischial tuberosity, sacrum, etc.)\n* Individuals who would be classified as NE or PR3-PD - FISA Para-Rowing Classifications\n* Flap procedure to address pressure injury less than one year prior\n* Upper extremity pain that restricts rowing\n* Surgical procedure within past 6 months that would make the study procedures unsafe (e.g., tendon repairs\u002Ftransfers, neural decompressions, bony fusions, etc.)\n* Upper extremity or spine fractures within past 3 months, or longer if remains unstable\u002Fnot fully healed.\n* Medical conditions such as cardiovascular disease, pulmonary disease, or other conditions that would make the study procedures unsafe pregnancy\n* Inability to communicate with the study team in real time\n* Inability to follow simple commands\n* Unable or unwilling to give consent",{"count":211,"type":22},15,[25],"Adaptive sports programs are integral components to combating Veteran isolation, promoting wellbeing and seeking to build teams, networks, communities. These activity-based communities are medicine free treatment systems enhancing Veterans' health from a holistic perspective. This approach to Veteran healthcare is critical as studies indicate Veterans not only have 56% higher perceived social isolation but are also 1.5x more susceptible to suicide than the general public. It is imperative to improve access to exercise and physical activity through adaptive sport or recreation. This proposal is going to focus on Adaptive Indoor Rowing for Veterans with limited or changing trunk stability (i.e. SCI\u002FD, paralysis, paresis, etc.). Rowing is a unique full-body activity that increases cardiovascular demand and increases coordination and aerobic capacity through movement. This proposal aims to address critical gaps in adaptive rowing technology and provide Veterans with limited trunk stability access to full stroke adaptive rowing.",[31,28,215,216],"Neurodegenerative Disorders","Cerebrovascular Accident With Associated Sequelae",[218,219,220,221,222,223],"Veteran Health","Sports for Persons with Disabilities","Paralysis","Paresis","Adaptive Sports","Indoor Rowing","2025-07-25",{"date":226,"type":47},"2025-08-01",{"date":228,"type":22},"2026-07-06",{"date":230,"type":22},"2028-09-30",{"name":115,"class":116},2,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":55},"100521232","prophylactic-pregabalin-treatment-following-spinal-cord-injury-100521232","NCT06066918","Prophylactic Pregabalin Treatment Following Spinal Cord Injury","The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain","Inclusion Criteria:\n\n* Up to 3 months following traumatic or non-traumatic SCL\n* Ability to give informed consent and cooperate\n\nExclusion Criteria:\n\n* Pregnancy\n* Neurological or other medical conditions that may interfere with sensation\n* Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)\n* Being treated with Pregabalin\n* Blood creatinine levels \\>1.2 or creatinine clearance \\\u003C60\n* Sensitivity to lactose",{"count":241,"type":22},50,[25],"Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.",[28,31],"2025-06-18",{"date":247,"type":47},"2025-06-24",{"date":249,"type":47},"2021-07-13",{"date":251,"type":22},"2026-02-05",{"name":253,"class":54},"Loewenstein Hospital",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":261,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":266,"conditions":267,"keywords":283,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":232},"100397880","phase-2-locomotor-training-with-testosterone-to-promote-bone-and-muscle-health-after-spinal-cord-injury-100397880","NCT04460872","Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury","Locomotor Training With Testosterone to Promote Bone and Muscle Health","Inclusion Criteria:\n\n* Men \\>18 years of age\n* Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \\>60-days\n* Low serum total testosterone (\\\u003C300 ng\u002FdL), bioavailable testosterone (\\\u003C110 ng\u002FdL), or free testosterone (\\\u003C46 pg\u002FmL or \\\u003C4.6 ng\u002FdL)\n* Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\\\u003C6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone\n* Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m\u002Fs on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace \\>1.0 m\u002Fs with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer.\n* Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology\n* Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation\n* Willingness to administer TRT as instructed by the study staff and to abide by study protocol\n* Documented approval from the study physician verifying medical status\n\nExclusion Criteria:\n\n* Currently participating in another research protocol that may influence study outcomes.\n* Mental state that precludes understanding the study protocol.\n* Life expectancy \\\u003C12-months.\n* History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures\n* Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury\n* Current prostate, breast, or other organ cancer or a history of prostate or breast cancer\n* Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated\n* Serum prostate-specific antigen (PSA) \\>3.0 ng\u002FmL \\[men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng\u002FmL\\]\n* Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer\n* Currently seeking fertility or expected during the duration of the study\n* Gynecomastia\n* Hematocrit (HCT) \\>49%\n* Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)\n* Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)\n* Poorly compensated congestive heart failure (NYHA class III or IV)\n* Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications\n* Poorly controlled arrhythmia of any type\n* Severe valvular heart disease\n* Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events\n* History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia\n* LDL cholesterol \\>160 mg\u002FdL with history of any major CV event, defined above, within the last 12-months\n* Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and\u002For a major surgery scheduled at the time of screening\n* Liver enzymes (AST or ALT) \\>1.5 times the normal upper limit\n* Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n* Diagnosed, but untreated severe obstructive sleep apnea\n* Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)\n* Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD \\\u003C0.70 g\u002Fcm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)\n* Current anticoagulant therapy (contraindication for i.m. injections)\n* Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone\n* Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days\n* Acute use (\\>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids \\>7.5 mg\u002Fd prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration\n* Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed oil)\n* Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration","MALE",{"count":263,"type":22},21,[265],"PHASE2","This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.",[268,28,33,269,130,31,270,271,272,273,274,275,276,277,278,279,35,280,281,282],"Spinal Cord Injury","Wounds and Injury","Gonadal Disorders","Endocrine System Diseases","Hypogonadism","Genital Diseases, Male","Spinal Cord Trauma","Injuries, Spinal Cord","Walking, Difficulty","Gait Disorders, Neurologic","Locomotion Disorder, Neurologic","Wounds and Injuries","Testosterone Deficiency","Androgen Deficiency","Hormone Deficiency",[284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,268],"Testosterone","Testosterone enanthate","Testosterone undecanoate","Testosterone 17 beta-cypionate","Methyltestosterone","Androgens","Hormones","Hormone Substitutes, and Hormone Antagonists","Physiologic Effects of Drugs","Pharmacologic Actions","Therapeutic Uses","Anabolic Agents","Testosterone Replacement Therapy","Dual Energy X ray Absorptiometry","Lean Tissue Mass","Body Composition","Muscle Strength","Muscle Mass","Bone Mineral Density","Adipose Tissue","Body Fat","Density, Bone","Bone Formation","Bone Resorption","Bone Density Conservation Agents","Magnetic Resonance Imaging","Walking","Ambulation","Locomotor","Locomotion","Treadmill","2025-05-01",{"date":317,"type":47},"2025-05-06",{"date":319,"type":47},"2021-01-31",{"date":321,"type":22},"2026-06-30",{"name":323,"class":54},"North Florida Foundation for Research and Education",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":173,"sex":17,"minAge":18,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":343,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":55},"100584618","use-of-tdcs-stimulation-in-neurological-and-gynaecological-conditions-100584618","NCT06891690","Use of TDCS Stimulation in Neurological and Gynaecological Conditions","tDCS","Neurological patients\n\nInclusion Criteria:\n\n* impairment of upper and lower limb function.\n\nExclusion Criteria:\n\n* no written consent to participate in the study.\n\nGynaecological patients\n\nInclusion Criteria:\n\n* women with selected gynaecological conditions (endometriosis, painful menstruation, dyspareunia, polycystic ovary syndrome) with no treatment other than tDCS stimulation.\n\nExclusion Criteria:\n\n* no written consent to participate in the study.","90 Years",{"count":333,"type":22},300,[25],"The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients. And the impact of tDCS stimulation on patients' quality of life. Standardised questionnaires will be used for pre- and post-stimulation evaluation.",[337,31,338,339,340,341,342],"Stroke","Nerve Root Disorder","Endometriosis","Dyspareunia","Painful Menstruation","Polycystic Ovary",[344,345,346],"tDCS stimulation","quality of life","pain","2025-03-17",{"date":349,"type":47},"2025-03-24",{"date":351,"type":47},"2025-02-05",{"date":353,"type":22},"2025-12-31",{"name":355,"class":54},"Poznan University of Physical Education",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":23,"phases":366,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":381,"locationsCount":384},"100578921","phase-1-ng004-in-spinal-cord-injury-patients-100578921","NCT06817577","NG004 in Spinal Cord Injury Patients","A First-in-human (FIH) Clinical Trial to Investigate the Human Monoclonal Antibody NG004, Administrated Intrathecally in Acute Spinal Cord Injury (SCI) Patients","SPROUT","Inclusion Criteria:\n\n* Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) C-D at Screening\n* 4-28 days post-injury\n* No required mechanical ventilation or patients that not completely depend on mechanical ventilation\n* Hemodynamically and clinical stable patient according to the acute SCI condition at baseline\n\nExclusion Criteria:\n\n* Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds\n* Multiple levels of clinically relevant spinal cord lesions\n* Major brachial or lumbar plexus damage\u002Ftrauma\n* Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function\n* Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy\n* History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis\n* History of refractory epilepsy\n* History of or current autoimmune disease\n* Patients with uncontrolled bleeding diathesis and\u002For who require concomitant therapeutic anticoagulation and not related to SCI\n* Presence of any unstable medical or psychiatric condition\n* Drug dependence any time during the 6 month's preceding trial entry\n* Pregnant or nursing women\n* History of a life-threatening allergic or immune mediated reaction\n* Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections\n* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations\n* Patients who are unconscious","70 Years",{"count":263,"type":22},[367],"PHASE1","This is the FIH, multicenter, open-label, sequential, multiple ascending dose trial of NG004 in patients with acute incomplete cervical SCI. The trial will evaluate the safety, tolerability, and PK of 4 dose regimens of NG004, and will evaluate the maximum tolerated dose of NG004.",[370,31,130,35,33,371,279],"Acute Spinal Cord Injury (SCI)","Spinal Cord Injuries (SCI)",[136,373,362,374],"Nogo-A","Regeneration","2025-02-04",{"date":377,"type":47},"2025-02-10",{"date":379,"type":47},"2024-12-18",{"date":49,"type":22},{"name":382,"class":383},"NovaGo Therapeutics AG","INDUSTRY",6,{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":399,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":4},"100478348","interventional-cooperative-agreement-program---vocational-intervention-demonstration-100478348","NCT05508802","Interventional Cooperative Agreement Program - Vocational Intervention Demonstration","Inclusion Criteria:\n\n* Adults aged 18-62\n* New Jersey resident\n* Admitted to Kessler Institute for Rehabilitation (KIR) due to a spinal cord injury (SCI) or brain injury (BI)\n* Receiving inpatient rehabilitation at KIR\n* Community living in the state of New Jersey after discharge from KIR","62 Years",{"count":393,"type":22},500,[25],"For many people with spinal cord injury or brain injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury or brain injury obtain employment.",[28,397,398,31],"Brain Injuries","Employment",[400,401],"employment","vocational rehabilitation","2022-08-17",{"date":404,"type":47},"2022-08-19",{"date":406,"type":22},"2022-10-01",{"date":408,"type":22},"2026-10",{"name":53,"class":54},{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":391,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":421,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":4},"100478183","early-intervention-to-promote-return-to-work-for-people-with-spinal-cord-injury-100478183","NCT05506657","Early Intervention to Promote Return to Work for People With Spinal Cord Injury","Inclusion Criteria:\n\n* adults age 18 to 62\n* a neurological impairment secondary to an SCI that occurred less than 12 months prior to enrollment\n* receiving inpatient rehabilitation at Kessler Institute for Rehabilitation (KIR)\n* community living in the state of NJ after discharge from KIR\n* have a goal to pursue competitive integrated employment or education\u002Fretraining leading to competitive integrated employment",{"count":417,"type":22},162,[25],"For many people with spinal cord injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury obtain employment.",[28,31],[400,401],{"date":423,"type":47},"2022-08-18",{"date":425,"type":22},"2022-09-30",{"date":427,"type":22},"2026-08-31",{"name":53,"class":54},{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":55},"100410973","phase-3-regeneration-in-cervical-degenerative-myelopathy-100410973","NCT04631471","Regeneration in Cervical Degenerative Myelopathy","Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy","RECEDE","Inclusion Criteria:\n\n* Patients suffering from degenerative cervical myelopathy as per established criteria who have granted informed consent to participate in the trial\n* Have a preoperative mJOA score ≥8 and ≤14\n* Scheduled for first surgical decompression as part of usual NHS clinical practice\n\nExclusion Criteria:\n\n* Previous surgery for DCM\n* DCM symptoms due to cervical trauma (at the discretion of the investigator)\n* Hypersensitivity to Ibudilast or any of the formulation components\n* Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation including ALP\\> 1.5x ULN; ALT or AST \\> 2x ULN; GGT \\> 3x ULN\n* Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years\n* Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation\n* Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception\n* Female patients who are pregnant, lactating or planning pregnancy during the course of the trial\n* Inability to comply with study procedures, IMP regime or follow-up schedule\n* Unable to take a gelatin based product\n* Participation in another CTIMP or device within the past 30 days from the time of recruitment\n* Functional disability from a commitment neurological disease that would mask the symptoms of DCM (at the discretion of the investigator). Including but not limited to stroke with residual disability, cerebellar ataxia, Parkinson's disease, symptomatic lumbar stenosis and multiple sclerosis\n* Resting pulse \\\u003C 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF \\> 450 ms\n* History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug\n* Unable to converse, read or write English at primary school level","80 Years",{"count":439,"type":22},400,[441],"PHASE3","Degenerative (wear and tear arthritis of the spine) Cervical (concerning the neck) Myelopathy (injury to the spinal cord), DCM, is the most common spinal cord disorder of adulthood. In DCM, arthritis of the spine causes compression of the spinal cord.\n\nThe symptoms of DCM are often mistaken for natural consequences of ageing, including numb and clumsy hands, loss of coordination, imbalance, bladder and bowel problems. The weakness can progress to severe paralysis. Every year approximately 4 individuals in 100,000 undergo surgery for DCM; however, many more individuals are thought to suffer from DCM.\n\nThe main treatment for DCM is surgery. The aim of surgery is to create space and remove the compression of the spinal cord. This is known to prevent further injury. Unfortunately, the post-operative improvements are often incomplete and many patients remain severely disabled. Improving outcome after surgery represents an important unmet clinical need.\n\nClinical and preclinical findings indicate that the drug Ibudilast can stimulate neuroprotective and regenerative processes in the spinal cord. Ibudilast is well-tolerated and used to treat asthma and post-stroke dizziness in Japan and is currently being investigated for use in treating other neurological diseases.\n\nThis study will investigate whether daily oral administration of Ibudilast for a maximum of 34 weeks can improve hand function, strength, balance, urinary problems and reduce pain.\n\nThe study will initially be conducted at three sites in the UK, with more sites added as necessary. Individuals between 18-80 years old, diagnosed with DCM and scheduled for an operation for the first time will be invited to participate in the trial. The study will entail patient questionnaires and clinical assessments before surgery, shortly after surgery and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans pre-operatively and at 6-months postoperatively to determine whether the treatment was successful.",[444,31],"Myelopathy",[446,447,444],"Degenerative","Cervical","2021-12-24",{"date":450,"type":47},"2022-01-13",{"date":452,"type":47},"2021-12-22",{"date":454,"type":22},"2026-09-01",{"name":456,"class":54},"Cambridge University Hospitals NHS Foundation Trust"]