[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bronx VA Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,77],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100548221","phase-2-dose-optimization-of-mdma-assisted-therapy-for-ptsd-100548221",false,"NCT06418178","Dose Optimization of MDMA-Assisted Therapy for PTSD","A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans","DosOp","Inclusion Criteria:\n\n1. Are a U.S. military veteran at least 18 years old.\n2. Are able to provide written, informed consent.\n3. Are able to swallow pills.\n4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.\n5. Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.\n6. If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods.\n7. Must have a current PTSD diagnosis at screening and baseline.\n8. Must not participate in any other interventional clinical trials for the duration of the study.\n9. Must commit to medication dosing, therapy, and all study procedures.\n\nExclusion Criteria:\n\n1. Are not able to give adequate informed consent.\n2. Have a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving a sympathomimetic drug harmful.\n3. Have uncontrolled hypertension.\n4. Have evidence or history of significant medical or psychiatric disorders.\n5. Have symptomatic liver disease.\n6. Have history of hyponatremia or hyperthermia.\n7. Weigh less than 48 kilograms (kg).\n8. Unable or unwilling to safely taper off prohibited psychiatric medication.\n9. Abusing illegal drugs or alcohol.\n10. Have received Electroconvulsive Therapy (ECT) or ketamine therapy within 12 weeks of enrollment.\n11. Are pregnant or nursing or are able to become pregnant and are not practicing an effective means of contraception.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.",[27],"Posttraumatic Stress Disorder",[27,29,30,31],"MDMA-Assisted Therapy","Dose Optimization","Veterans","RECRUITING","2026-10-05",{"date":35,"type":36},"2026-10-08","ACTUAL",{"date":38,"type":36},"2025-06-03",{"date":40,"type":21},"2029-10",{"name":42,"class":43},"Bronx VA Medical Center","FED",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":44},"100617940","the-effect-of-exoskeletal-assisted-walking-combined-with-transcutaneous-spinal-cord-stimulation-on-bone-strength-100617940","NCT07325149","The Effect of Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation on Bone Strength.","Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.","* Participant Screening:\n\n  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurological assessment examination to determine the level and completeness of SCI when participants screen for entry into the study. The ISNCSCI exam will be performed by the study physician using a tool that assesses sensory function (light touch and pinprick) in each dermatome (A dermatome is an area of skin that sends touch, pain, temperature, and other sensory signals back to the brain) and motor function (motor function is a general term to describe the way muscles create movement) in ten key muscles. This test will determine the level of SCI, defined as the lowest spinal level with normal function, and assigns a classification of severity according to the ISNCSCI scale. In this study, both ISNCSCI grade C and grade D would make a participant eligible for this study.\n  2. DXA study to assess bone mineral density (BMD) at the total hip (TH), distal femur (DF), and proximal tibia (PT) that will be compared to the cutoff values described in the exclusion criteria section.\n  3. Medical history and exam to ensure medical health, anthropometric compatibility for EAW, and to identify fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs.\n* Inclusion Criteria:\n\n  1. Between the ages of 21-60 years old\n  2. Non-walkers with an SCI greater than 3 years post injury.\n  3. As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D.\n  4. Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening).\n  5. Capable of gripping Lofstrand crutches and\u002For a walker without assistance.\n  6. Wheelchair reliant 100% of the time.\n  7. Height is between 62 inches and 74 inches.\n  8. Weight less than 220lbs.\n  9. Anthropometric compatibility with the EAW device:\n\n     * Thigh length between 14 and 19 in (36 and 48 cm).\n     * Shank length between 17 and 22 in (43 and 55 cm).\n* Exclusion Criteria:\n\n  1. As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs.\n  2. Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)\n  3. As determined by the study physician from the screening DXA study, a T-score at the total hip \\\u003C -3.5 or aBMD of the knee (proximal tibia and\u002For distal femur) \\\u003C 0.60 g\u002Fcm2 from the DXA screen\n  4. Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation.\n  5. Currently in a gym\u002Frehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff.\n  6. Currently prescribed any medications that can affect muscle and\u002For bone metabolism, as determined by the study staff.\n\nExclusion Criteria from MRI Safety Screening:\n\n1. Medically unsafe to receive an MRI scan.\n2. Claustrophobia\n3. Baclofen pump\n4. Body metal, including any of the following:\n\n   * metal fragments or pieces in eyes or any other part of body\n   * pacemakers or other implanted electrical devices\n   * aneurysm clips (metal clips on wall of a large artery)\n   * metallic prostheses (metal pins and heart valves)\n   * internal hearing aids (cochlear implants)\n   * permanent eyeliner\n   * shrapnel fragments\n   * piercing that cannot be removed","21 Years","60 Years",{"count":55,"type":21},24,[57],"NA","Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and\u002For exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.",[60,61],"Secondary Osteoporosis","Sarcopenia",[63,64,65,66,67],"Spinal Cord Injury","Transcutaneous Spinal Cord Stimulation","Bone Mineral Density","Exoskeleton-Assisted Walking","Muscle Cross Sectional Area","NOT_YET_RECRUITING","2026-01-06",{"date":71,"type":36},"2026-01-08",{"date":73,"type":21},"2026-07-01",{"date":75,"type":21},"2033-06-01",{"name":42,"class":43},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":44},"100524132","finding-the-best-combination-of-brain-and-spinal-cord-stimulation-with-hand-training-after-spinal-cord-injury-100524132","NCT06104735","Finding the Best Combination of Brain and Spinal Cord Stimulation With Hand Training After Spinal Cord Injury","Optimizing Spinal Cord Associative Plasticity to Enhance Response to Hand Training in Cervical Spinal Cord Injury","Inclusion Criteria:\n\n* Age between 18-85 years.\n* Must have stable prescription medication for 30 days prior to screening\n* Must be able to: abstain from alcohol, smoking and heavy caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 53 visits); provide informed consent.\n* Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.\n\nExclusion Criteria:\n\n* Personal or extensive family history of seizures;\n* Ventilator dependence or patent tracheostomy site;\n* History of stroke, brain tumor, brain abscess, or multiple sclerosis;\n* History of severe head trauma requiring neurosurgery;\n* History of implanted brain\u002Fspine\u002Fnerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker\u002Fdefibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;\n* Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV;\n* Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);\n* History of significant hearing problems;\n* History of bipolar disorder;\n* History of suicide attempt;\n* Active psychosis;\n* Recent history (\\>1 year) of chemical substance dependency or significant psychosocial disturbance;\n* Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;\n* Open skin lesions over the face, neck, shoulders, or arms;\n* Pregnancy; and\n* Unsuitable for study participation as determined by study physician.","85 Years",{"count":86,"type":21},12,[57],"While physical exercise remains the foundation for any rehabilitation therapy, the team seeks to improve the benefits of exercise by combining it with the concept of \"Fire Together, Wire Together\" - when brain stimulation is synchronized with spinal cord stimulation, nerve circuits in the spinal cord strengthen - a phenomenon termed \"Spinal Cord Associative Plasticity\", or SCAP.\n\nThis project will build on the team's promising preliminary findings. When one pulse of brain stimulation is synchronized with one pulse of cervical spinal stimulation, hand muscle responses are larger than with brain stimulation alone or unsynchronized stimulation. However, the team does not know the best ways to apply SCAP repetitively, especially in conjunction with exercise, to increase and extend improvements in clinical function. Do ideal intervention parameters vary across individuals, or do they need to be customized?\n\nThe team will take a systematic approach with people who have chronic cervical SCI to determine each person's best combination of SCAP with task-oriented hand exercise. Participants will undergo up to 53 intervention, verification, and follow-up sessions over a period of 6 to 10 months each. The team will measure clinical and physiological responses of hand and arm muscles to each intervention.\n\nRegaining control over hand function represents the top priority for individuals with cervical SCI. Furthermore, this approach could be compatible with other future interventions, including medications and cell-based treatments.",[90],"Spinal Cord Injuries",[92,93,94,95],"neuromodulation","spinal cord stimulation","task-oriented exercise","transcranial magnetic stimulation","2025-10-21",{"date":98,"type":36},"2025-10-22",{"date":100,"type":36},"2024-05-24",{"date":102,"type":21},"2026-12-31",{"name":42,"class":43},""]