[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Louis Stokes VA Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,80,111],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100317169","feasibility-of-neural-feedback-for-lower-limb-amputees-100317169",false,"NCT03409133","Feasibility of Neural Feedback for Lower Limb Amputees","Inclusion Criteria:\n\n* Adults age 18 or greater\n* Chronic, medically stable ( \\> 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.\n* Potential user of trans-tibial or trans-femoral prostheses for standing or walking\n* Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like\n* Good skin integrity and personal hygiene\n* Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation\n* Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule\n\nExclusion Criteria:\n\n* Uncontrolled diabetes to a degree that would preclude surgery\n* Significant vascular disease\n* Chronic skin ulcerations\n* Significant history of poor wound healing\n* Significant history of uncontrolled infections\n* Active infection\n* Significant pain in the residual or phantom limb\n* Pregnancy\n* Inability to speak English\n* Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place\n* Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Poor surgical candidate\n* Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.","ALL","18 Years",{"count":18,"type":19},15,"ESTIMATED","INTERVENTIONAL",[22],"NA","The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation.\n\nIndividuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.",[25],"Amputation",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"prosthesis user","phantom sensation","sensory feedback","prosthesis","amputee","amputation","limb loss","robotic prosthesis","neuroprosthesis","sensory restoration","robotic","electromyography","EMG","sensation","myoelectric","RECRUITING","2026-03-04",{"date":45,"type":46},"2026-03-06","ACTUAL",{"date":48,"type":46},"2015-11-05",{"date":50,"type":19},"2027-09-01",{"name":52,"class":53},"Louis Stokes VA Medical Center","FED",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":20,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":54},"100590262","implant-for-walking-after-incomplete-sci-100590262","NCT06965127","Implant for Walking After Incomplete SCI","Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis","Inclusion Criteria:\n\n* Between the ages of 18-75\n* Non-ventilator dependent paralysis resulting from injuries such as: cervical\u002Fthoracic spinal cord injuries affecting the trunk and\u002For lower limbs\n* Impairment classification of AIS B, C, or D (preservation of sensation and\u002For some motor function) with weakness in trunk and\u002For lower extremity muscles\n* Unable to walk faster than 0.8m\u002Fs during a 10m walk test\n* Gait deviation such as reduced peak hip, knee, and\u002For ankle range of motion during stance or swing phases due to motor impairment\n* Time post injury greater than six months\n* Innervated and excitable lower extremity and trunk musculature\n* Adequate social support and stability\n* Willingness to comply with follow-up procedures\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Neurologically stable as determined by a physician\n\nExclusion Criteria:\n\n* Significant fracture risk or history of spontaneous fractures\n* History of heterotopic ossification at the hip, knee, or ankle\n* Non-English speaking\n* Insufficient upper extremity function to use an assistive device (e.g. walker or cane)\n* Females who are pregnant\n* Current pressure injury that would be exacerbated by study activities\n* Uncontrolled spasticity that would interfere with study activities\n* Significant range of motion limitations that would compromise study activities\n* History of vestibular dysfunction, balance problems, or spontaneous falls\n* Disorder or condition that require MRI monitoring\n* Acute and\u002For untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture\n* Acute and\u002For chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological\u002Fpulmonary\u002Frenal\u002Fcirculatory compromise\n* Uncontrolled diabetes or hypertension\n* Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs\n* Any other medical or psychological condition that would be a contraindication\n\nImplant eligibility criteria\n\n• In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.","75 Years",{"count":64,"type":19},5,[22],"This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.",[68,69],"Spinal Cord Injury (SCI)","Gait",[35,71],"implanted device","2025-11-20",{"date":74,"type":46},"2025-11-26",{"date":76,"type":46},"2025-08-27",{"date":78,"type":19},"2031-08",{"name":52,"class":53},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":15,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":20,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":54},"100573464","nonendoscopic-screening-for-barretts-esophagus-in-veterans-without-chronic-reflux-100573464","NCT06746623","Nonendoscopic Screening for Barrett's Esophagus in Veterans Without Chronic Reflux","Nonendoscopic Screening for Barrett's Esophagus and Esophageal Cancer in At-Risk Veterans Without History of Chronic Gastroesophageal Reflux","Inclusion Criteria:\n\n* Patients without history of chronic GERD who meet criteria for upper endoscopic screening for BE will be accrued35.\n\n  1. Adults \\> 40 and \\\u003C 85 years old who have no prior EGD and can provide informed consent\n  2. Absence of chronic GERD symptoms (absence of weekly heartburn or regurgitation, not on medications for GERD), and are:\n\n     a. Meet ACG\u002FAGA Clinical Guideline criteria for BE screening. Eligible subjects will have at least three additional risk factors for BE (white race, obesity defined as BMI \\> 30, male gender, current smoker or smoking history \\> 10 pack years, family history of Barrett's esophagus or EAC central obesity (waist size \\> 35 inches for women and \\> 40 inches for men), white race, male sex, confirmed history of BE\u002FEAC in at least two family members, with one a first degree relative).\n  3. No known coagulopathy, no known esophageal varices, not on chronic anticoagulation therapy, and have:\n  4. No significant dysphagia or odynophagia\n\nExclusion Criteria:\n\n* Exclusion Criteria\n\n  1. History of prior EGD procedure in past ten years\n  2. Inability to provide written informed consent\n  3. History of weekly or more frequent heartburn or regurgitation for five or more years\n  4. On anti-coagulant drug(s) that cannot be temporarily discontinued or coagulopathy with INR \\> 1.5\n  5. Known history of esophageal varices or esophageal stricture\n  6. Any contraindication, as deemed in Investigator's medical judgment, to undergoing the EsoCheck procedure, undergoing the EGD procedure, and\u002For having biopsies taken, including but not limited to due to comorbidities such as coagulopathy or a known history of esophageal diverticula, esophageal fistula and\u002For esophageal ulceration\n  7. History of difficulty swallowing (dysphagia) or painful swallowing (odynophagia), including swallowing pills\n  8. Oropharyngeal tumor\n  9. History of esophageal or gastric surgery, with exception on uncomplicated recent surgical fundoplication procedure with documented normal acid exposure time (AET) percent (AET \\\u003C4%)\n  10. History of myocardial infarction or cerebrovascular accident within past 6 months","40 Years","85 Years",{"count":90,"type":19},400,[22],"The veteran population is at increased risk for EAC and its precursor lesion, Barrett's esophagus (BE), due to increased prevalence of disease risk factors compared to the general population. BE is traditionally diagnosed only when patients undergo endoscopy with biopsies. However, due to the high cost of endoscopy and the lack of studies proving efficacy of screening, endoscopy to screen for BE is not routinely recommended. A simpler screening procedure similar to a pap smear would be an ideal way to sample the esophageal tissue for cancer and its precursor condition, BE. This study proposes a non-endoscopic detection method administered in outpatient offices which would increase subsequent endoscopic detection of BE. The study team will be enrolling veterans who do not have history of gastroesophageal reflux but have multiple risk factors for esophageal adenocarcinoma.",[94,95,96,97,98],"Obese Patients","Tobacco Use","Veterans","Family History of Esophageal Cancer","Barrett Esophagus",[100,101,102],"Non-endoscopic screening","esophagus","Barrett","2025-06-03",{"date":105,"type":46},"2025-06-05",{"date":107,"type":46},"2025-04-11",{"date":109,"type":19},"2028-12-31",{"name":52,"class":53},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":54},"100428144","evaluating-the-experience-of-upper-limb-prosthesis-use-100428144","NCT04855214","Evaluating the Experience of Upper Limb Prosthesis Use","Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology","Inclusion Criteria:\n\n* 18 years or older\n* Ability to give verbal informed consent\n* Ability to speak and understand English\n* Unilateral acquired trans-radial or trans-humeral amputee\n* At least six months from time of limb loss\n* Current user of an upper limb prosthesis\n* Use of the device they will be describing for at least six months (with the exception of sensory augmentation)\n\nExclusion Criteria:\n\n* Significant hearing impairment which would prevent telephone communication.\n* Unwillingness or inability to discuss experiences with prostheses\n* Emotional disturbance related to discussion the prosthesis or limb loss",{"count":119,"type":19},178,"OBSERVATIONAL","The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use.\n\nThis conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.",[123,25,124,125,126],"Prosthesis User","Upper Limb Amputation at the Wrist","Upper Limb Amputation Above Elbow (Injury)","Upper Limb Amputation Below Elbow (Injury)",[128,129,130,131,132,133,134,135,136,137,138,139,140],"Upper Limb Prosthesis User","Survey","Interview","User Experience","Body-powered","Myoelectric","Multiple degree of freedom","Sensory Feedback","Prosthetic device features","Upper Limb Loss","Amputee","Outcome Acceptance","Qualitative Research","2025-04-01",{"date":143,"type":46},"2025-04-04",{"date":145,"type":46},"2020-12-16",{"date":147,"type":19},"2026-09-30",{"name":52,"class":53},""]