NCT05423600 Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
| NCT ID | NCT05423600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virginia Commonwealth University |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2022-06-15 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2022-06-15 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the current study is to evaluate whether a home-based, telehealth-supported intervention combining Blood Flow Restricted Exercise (BES) and Transspinal Stimulation (TS) will improve motor and functional abilities greater than BES+sham TS in persons with chronic, incomplete tetraplegia.
Eligibility Criteria
Inclusion Criteria: 1. A written clearance from the study medical doctor to ensure that the participant is safely able to engage in the study. 2. Participants must have a companion that will be able to help him/her throughout the study. 3. Greater than 1-year post SCI, neurologic level of C8 or above. 4. American Spinal Injury Association Impairment Scale (AIS) scores of B, C, or D indicating presence of an incomplete SCI. 5. Visible muscle contraction response to NMES wrist extensors, bilaterally. 6. Agreement to use telehealth services for delivery of research exercise training by study staff. Possesses appropriate technology to engage in telehealth including a personal web camera, computer, microphone, speakers, and high-speed broadband internet connection, valid email address (needed to obtain VA issued video conferencing software), and telephone number used to obtain login credentials for the In-Home Video Software - Cisco Jabber Video for Telepresence Software. 7. Response of muscle contraction of wrist extensors bilaterally to neuromuscular electrical stimulation. Exclusion Criteria: 1. Unhealed fracture in upper or lower extremities. 2. Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues that would impede participation in a BES + TS intervention or valid evaluation of outcome measures. 3. High resting blood pressure greater than 140/80 mmHg. 4. Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons. 5. Pregnancy (female participants). A home pregnancy test will be conducted to role out any pregnancy before the study at the McGuire VAMC. The test will be repeated every month during the course of the study. 6. Implanted pacemakers and/or implanted defibrillator devices. 7. Other exclusion criteria may include the presence of implanted electrical device, cancer, thrombosis, pacemaker, defibrillator, or seizures. Patients who are currently on or receive anti-platelet or anticoagulant medications will be excluded from the trial. 8. Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study. 9. Other exclusion criteria at the discretion of the medical team may include: 1. Uncontrolled autonomic dysreflexia (AD), refers to episodes of AD that do not respond to medications to ensure stable blood pressure in persons with SCI 2. Concurrent severe neurological injuries other than SCI: MS, CP, severe TBI, and stroke. 3. Unresolved deep vein thrombosis. 4. Psychiatric or cognitive impairments that preclude adherence to the intervention. 5. Known cardiac pathology that precludes safe participation. 6. Metabolic conditions such as cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin. 7. Presence of pressure sores stage three or greater. 8. Presence of a symptomatic urinary tract infection. 9. Severe spasticity as assessed by the Modified Ashworth Scale. 10. Changing neurologic status due to conditions such as progressive posttraumatic syringomyelia.
Contact & Investigator
Ashraf Gorgey, MPT, PhD, FACSM, FACRM
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05423600 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Tetraplegia/Tetraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05423600 currently recruiting?
Yes, NCT05423600 is actively recruiting participants. Contact the research team at Ashraf.Gorgey@va.gov for enrollment information.
Where is the NCT05423600 trial being conducted?
This trial is being conducted at Richmond, United States, Richmond, United States, Richmond, United States.
Who is sponsoring the NCT05423600 clinical trial?
NCT05423600 is sponsored by Virginia Commonwealth University. The principal investigator is Ashraf Gorgey, MPT, PhD, FACSM, FACRM at Virginia Commonwealth University. The trial plans to enroll 44 participants.