[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Craig Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":189},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,63,95,118,144,169],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100573232","spinal-stimulation-for-upper-extremity-recovery-in-the-home-100573232",false,"NCT06743607","Spinal Stimulation for Upper Extremity Recovery in the Home","Spinal Stimulation to Improve Upper Extremity Recovery in the Home (SSTIM UE Recover [SURe])","SURe","Inclusion Criteria:\n\n* Age 18 or older\n* History of traumatic SCI\n* Less than 12 months post SCI\n* SCI injury level C1-C8\n* SCI categorized as AIS B-D\n* Have passive range of motion (ROM) within functional limits at wrists, shoulders, and elbows\n* Have caregiver support to attend three in-person sessions and ongoing training at home\n* Have a caregiver who, in the judgment of the research team, is qualified to assist the participant in the safe use of TSS\n* Able to complete in-person training sessions and return to Craig Hospital for assessments\n* Experience no complicating physical or cognitive conditions as determined by their physician that would preclude the safe use of electrical stimulation\n* If using prescribed anti-spasticity medications, must be at a stable dose for at least four weeks prior to starting study procedures\n* Agrees to comply with investigational devices instructions for use, protocol visits, and return of the device\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Experience unstable chronic cardiac or respiratory complaints\n* Have a recent history of fracture, contractures, or skin pressure injuries that might interfere with the intervention\n* Received Botox injections to the UEs, neck, or hands within the last three months\n* Pregnant, planning to become pregnant, or currently breastfeeding\n* Have breakdown in skin area that will come into contact with electrodes\n* Prior nerve or tendon transfer procedure for the UEs\n* Concurrently are participating in another drug or device trial that may interfere with this study\n* Have an implanted pacemaker, spinal cord stimulator, ventriculoperitoneal shunt, deep brain stimulator, or intrathecal pump\n* In the opinion of the investigators, the study is not safe or appropriate for the participant","ALL","18 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this research is to evaluate the safety, feasibility, and tolerability of non-invasive spinal stimulation used in the home and\u002For community in combination with a functional home exercise program for the upper extremities (arm\u002Fhand function) as well as their combined impacts on changes in upper extremity function. The expected duration of participation in this study is about 31-33 hours over a 13-25-week period. Enrollees in this study will be randomly assigned to one of two groups: 1) upper extremity functional task-specific training combined with non-invasive transcutaneous spinal stimulation, or 2) waitlist control, which involves the same intervention, but with a 12-week delayed start. Participants complete initial testing (one time if in group one and three times \\[at weeks 0, 8, and 12\\] if in group two), 24 1-hour training sessions (2x\u002Fweek in home with caregiver\u002Fcompanion support and 1x\u002Fweek with research team in person or via video conference for 8 weeks), a post-treatment evaluation, and a final evaluation (4 weeks after post-treatment).",[27],"Cervical Spinal Cord Injury","RECRUITING","2026-03-26",{"date":31,"type":32},"2026-03-31","ACTUAL",{"date":34,"type":32},"2025-05-28",{"date":36,"type":21},"2027-08",{"name":38,"class":39},"Craig Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":40},"100542662","abdominal-functional-electrical-stimulation-to-improve-bowel-function-in-spinal-cord-injury-100542662","NCT06345781","Abdominal Functional Electrical Stimulation to Improve Bowel Function in Spinal Cord Injury","Inclusion Criteria:\n\n1. Chronic SCI (\\> 12 months since injury) above the level of T11\n2. \\> 18 years of age\n3. a measurable and consistent start and end event is determinable for the bowel routine\n\n   * Start events include: 1) enema insertion, 2) digital stimulation, 3) hot drink or initiation of the gastrocolic reflex, 3) abdominal massage, or 4) other, as determined by the participant and research team.\n   * Ending events include: 1) final digital stimulation, 2) when evacuation has ceased, or 3) other, as determined by the participant and research team.\n4. Portable smart device with video capabilities and internet access\n5. Willingness to access and\u002For download Zoom (videoconferencing software)\n\nExclusion Criteria:\n\n1. American Spinal Injuries Association (ASIA) Impairment Scale (AIS) E\n2. Self-reported bowel management time (BMT) of \\\u003C30 minutes\n3. Current bowel conditions such as gastro-esophageal reflux, bowel obstruction, Crohn's disease, or diverticulitis\n4. Physical obstacles that prevent AFES (e.g., pregnancy, abdominal trauma, cardiac pacemaker, or other implanted electromedical devices)\n5. Stoma or colostomy\n6. No response to AFES (e.g., lower motor neuron impairment)\n7. History of gastrointestinal surgery within the past 3 months\n8. Severely obese participants (\\>40 BMI)\n9. Primary language other than English\n10. Previous history of uncontrolled, recurrent episodes of AD\n11. Resting systolic blood pressure (BP) reported as \\>140 mmHg",{"count":48,"type":21},15,[24],"The primary objective of this study is to gather information about the effectiveness of abdominal FES to improve bowel management time (BMT) for people with chronic SCI. This study will also evaluate whether abdominal FES can improve: 1) bowel-related quality of life, 2) participant-reported bowel function, 3) bowel management strategy, 4) bladder symptoms, and 5) unplanned hospital admissions. In addition, we will also explore participant perspectives and experiences about the stimulation sessions and use of the device.",[52,53],"Spinal Cord Injuries","Neurogenic Bowel",[55,56,53],"Spinal Cord Injury","Functional Electrical Stimulation (FES)",{"date":31,"type":32},{"date":59,"type":32},"2025-04-30",{"date":61,"type":21},"2026-05",{"name":38,"class":39},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":70,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":40},"100610450","testosterone-deficiency-and-endothelial-dysfunction-after-spinal-cord-injury-100610450","NCT07227740","Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury","Testosterone Deficiency and Endothelial Dysfunction in Spinal Cord Injury Related Cardiovascular Disease Mechanistic Insights and Therapeutic Prospects","Inclusion Criteria:\n\n* Between ages 18-89 years of age\n* Male Sex\n* History of motor complete (AIS A\u002FB) paraplegia (NLI T3 or Below)\n* Time since injury \\\u003C6 months at time of enrollment (Subacute injury)\n* Testosterone Deficiency defined as \\\u003C 300ng\u002FdL\n\nExclusion Criteria:\n\n* Overt cardiovascular disease assessed by a) medical history, b) physical examination c) electrocardiogram\n* Anaphylaxis to betadine, lidocaine, iodine\n* Active infection at time of enrollment.\n* Recent surgery (\\\u003C1 month) at time of enrollment.\n* History smoking tobacco (currently or in the past 12 months)\n* History of more than low-risk history of alcohol consumption\n* History of drug abuse\n* History of use of cardiovascular-acting (i.e. statins, beta-blockers) therapeutics\n* History of other health habits, medications, and supplements that could influence the outcome measures deemed by principal investigators and investigative team.","MALE","89 Years",{"count":73,"type":21},48,"OBSERVATIONAL","Heart attacks and strokes are among the most common causes of premature death in individuals living with spinal cord injury (SCI) and appear to occur earlier in life. The factors that lead to the heighten and accelerated risk of heart attacks and strokes in adults living with SCI remain poorly understood. The investigators aim to uncover why this happens and find ways to prevent it. Our research focuses on how important cells which line blood vessels, called endothelial cells, function after SCI. The investigators test endothelial function in live conscious people with SCI. The investigators also study signaling molecules endothelial cells release called endothelial cell derived microvesicles (EMVs), which the investigators can measure in blood to tell us the health of endothelial cells. By using these rigorous tests of vascular function, the investigators have determined that endothelial cells appear dysfunctional after SCI. The investigators also know that many men with SCI have low testosterone levels. Our team has studied testosterone's effects on endothelial dysfunction and believe low testosterone may be contributing to endothelial dysfunction after SCI. By understanding these mechanisms, the investigators hope to improve the lives of those living with SCI and reduce their risk for heart attacks and strokes. The investigators propose to study the influence of testosterone on endothelial function by using state-of-the-art clinical and laboratory experiments to assess endothelial function in men with SCI with low and normal testosterone levels.",[52,77,78],"Endothelial Dysfunction","Testosterone Deficiency",[80,81,82,83,84,85,86],"spinal cord injury","endothelial dysfunction","testosterone deficiency","extracellular vesicles","microvesicles","vasodilation","fibrinolysis","2025-11-20",{"date":89,"type":32},"2025-11-21",{"date":91,"type":32},"2025-07-15",{"date":93,"type":21},"2028-07-14",{"name":38,"class":39},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":103,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":40},"100610449","endothelial-dysfunction-after-sci-100610449","NCT07227727","Endothelial Dysfunction After SCI","Endothelial Dysfunction After SCI: Mechanism and Therapeutic Target for SCI-related Cardiovascular Disease","EDASCI","SCI Inclusion Criteria\n\n* Over age 18 years\n* Chronic (\\>12 months) SCI\n* Motor complete (AIS A\u002FB) SCI\n* Paraplegia (neurological level of injury \\[NLI\\] at T2 or below)\n\nNon-injured Inclusion Criteria\n\n• Over age 18 years\n\nExclusion Criteria (Both SCI and Non-injured)\n\n* Overt chronic diseases as assessed by: a) clinically documented medical history; b) physical examination; c) blood pressure and ECG at rest; and d) complete blood chemistries and hematological evaluation.\n* Active infection\n* Recent (\\\u003C 3 months) surgery\n* Current smoking history (within past 12 months)\n* Report more than low-risk alcohol consumption\n* History of drug abuse\n* Currently taking cardiovascular (statins, beta-blockers) therapeutics and\u002For other medications that could influence the outcome measures",true,{"count":105,"type":21},40,"This study plans to learn how endothelial cells, single cell lining of blood vessels may be dysfunctional after a spinal cord injury. Endothelial dysfunction will be measured by the capacity of blood vessels to vasodilate (increase in size) and alter blood flow is lower in adults with a spinal cord injury in comparison to adults without a spinal cord injury. The mechanisms which may alter this function may be critical in reducing the risk of heart attacks and strokes in people with spinal cord injuries.",[52,77],[80,109,83,84],"endothelium-dependent vasodilation","2025-11-12",{"date":112,"type":32},"2025-11-14",{"date":114,"type":32},"2025-07-31",{"date":116,"type":21},"2027-07-30",{"name":38,"class":39},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100576053","phase-2-walking-with-overground-robotic-exoskeletons-to-improve-arrousal-in-individuals-with-disorders-of-consciousness-100576053","NCT06780280","Walking With Overground Robotic Exoskeletons to Improve Arrousal in Individuals With Disorders of Consciousness","ORE-DOC","Inclusion Criteria:\n\n* Individuals with DOC who are receiving inpatient rehabilitation\n\nExclusion Criteria:\n\n\\-",{"count":126,"type":21},25,[128,129],"PHASE2","PHASE3","This proposed study will examine a walking intervention to promote changes in conscious state in individuals with disorders of consciousness (DoC) due to acquired brain injury (ABI). Recent practice guidelines highlight the need to develop interventions to arouse patients with DoC, as current treatment options are scarce with limited to low-quality pharmaceutical and electrical stimulation approaches to improve outcomes. New data indicates patients with chronic DoC may benefit from therapeutic intervention prioritizing repeated multimodal sensory (i.e., simultaneous vestibular, proprioceptive, and visual) input, but likely not attain comparable functional recovery to those who demonstrate early command following ability. Interventions activating pathways of the cerebral consciousness network may leverage a substrate for recovery. We hypothesize that walking in an overground robotic exoskeleton (ORE) is safe, feasible, and will simultaneously stimulate endogenous cognitive and automatic pathways associated with walking5 to promote changes in behavioral performance in individuals with DoC.",[132],"Traumatic Brain Injuries",[134],"TBI, disorders of consciousness, walking, exoskeletons","NOT_YET_RECRUITING","2025-02-20",{"date":138,"type":32},"2025-02-24",{"date":140,"type":21},"2025-03-20",{"date":142,"type":21},"2026-01-30",{"name":38,"class":39},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":158,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":40},"100493206","phase-2-high-intensity-step-training-after-traumatic-brain-injury-100493206","NCT05702138","High Intensity Step Training After Traumatic Brain Injury","Improving Balance and Mobility After Traumatic Brain Injury: A Randomized Controlled Trial Evaluating High Intensity Step Training","B-HIST","Inclusion Criteria:\n\n* TBI definition: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness (LOC) or post traumatic amnesia (PTA) due to brain trauma or by objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination\n* Less than 6 months post injury at time of consent\n* Weight less than 298 pounds and height less than 6'2\" (based on treadmill contraindications)\n* Intact skin (no open lesions\u002Fbandages) in the area of treadmill harness contact\n* Able to walk ten feet requiring the physical assistance of not more than two people and\u002For bracing, assistive devices\n* Impaired walking speed of \\\u003C than 1.4 meters\u002Fsecond\n* Ability to follow directions\u002Fstandardized instructions\n* Minimum 18 years of age at consent\n* Completing or have completed initial inpatient rehabilitation for TBI\n* O-Log score of at least 20\n* Medically cleared for HIST by a physician\n\nExclusion Criteria:\n\n* Uncontrolled cardiopulmonary, metabolic, or infectious disorder\n* History of orthopedic or additional neurological disorder that limited motor function before TBI\n* Any reason that, in the opinion of the study investigators or medical team, would interfere with completing the study protocol such as behavioral concerns\n* Uncontrolled seizure disorder\n* Pregnant or lactating females\n* Current participation in any other interventional trials\n* History of an untreated or a poorly controlled psychiatric condition such as depression, schizophrenia, or bipolar disorder",{"count":153,"type":21},111,[128],"This study will explore whether the types and intensity of the interventions being delivered will yield measurable cognitive benefits in addition to improved mobility and balance.\n\nThe study evaluates three therapeutic approaches to improve mobility and balance after traumatic brain injury (TBI): Conventional Gait and Balance Training, high intensity step training, and high intensity step training with virtual reality.",[157],"Traumatic Brain Injury",[159,160,161],"balance","mobility","physical therapy",{"date":163,"type":32},"2025-02-21",{"date":165,"type":32},"2023-03-20",{"date":167,"type":21},"2027-08-31",{"name":38,"class":39},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":103,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":176,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":40},"100550136","role-of-endothelial-function-in-sci-cvd-risk-100550136","NCT06443151","Role of Endothelial Function in SCI CVD Risk","Role of Vascular Endothelial Function After Spinal Cord Injury Related Cardiovascular Disease Risk","Inclusion Criteria:\n\n* Men and women of all races, ethnic backgrounds\\>18 years of age\n* Traumatic spinal cord injury (Sports, Assault, Transport, Fall, Other Traumatic Causes)\n* Time since injury (\\> 12 months)\n* Paraplegia Motor Complete Injury (neurological level of injury at T2 or below, ASIA Impairment Scale A or B\n\nExclusion Criteria:\n\n* History of high blood pressure\n* History cardiovascular disease (coronary artery disease, congestive heart failure, myocardial infarction, cerebrovascular accident).\n* History high cholesterol\n* History of Diabetes Type I or Type II\n* History of Obstructive Pulmonary Disease\n* History of Chronic Kidney or Liver Disease\n* History of Cancer\n* History of Autoimmune Disease (Thyroid Disease, Lupus, Rheumatoid Arthritis, etc).\n* History of smoking tobacco in the last 12 months\n* History of alcohol use",{"count":177,"type":21},60,"Individuals with spinal cord injury have heart attacks and strokes more frequently, and much earlier in life. People with spinal cord injuries develop plaque in vessels much faster, and the reasons why are unclear. Doctors generally attributed the increased risk with weight gain and developing diabetes, but many studies have shown that even without these common factors, plaque in vessels is developing more often and faster. Endothelial cells are a single layer of cells that line all vessels in the body and plays an important role in vessel health. Damage to endothelial cells is known to lead to heart attacks and strokes. Past studies on endothelial cells of people with spinal cord injury have been unclear. The investigators have new data that these cells are unhealthy after spinal cord injury a measurement. This includes measuring endothelial health by directly altering its function using a catheter in the arm and measuring small particles in blood called endothelial microvesicles. If the project is successful, the investigators will learn important information on the health of endothelial cells after spinal cord injury. The investigators will also be able to use these markers of endothelial cell function to create treatments to improve vessel health and prevent heart attacks and strokes later in life in people with spinal cord injury.",[52,180,77],"Cardiovascular Diseases","2024-08-19",{"date":183,"type":32},"2024-08-20",{"date":185,"type":21},"2024-09-01",{"date":187,"type":21},"2027-03-30",{"name":38,"class":39},""]