Recruiting

Transspinal Stimulation & Blood Flow Restricted Exercise

Sponsor:

Virginia Commonwealth University

Code:

NCT05423600

Conditions

Tetraplegia/Tetraparesis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

BES + TS

Experimental: BES+sham TS

Study Details

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.

Conditions

Tetraplegia/Tetraparesis

Study ID

NCT05423600

Start date

Jun 15, 2022

Status verified date

Jul, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BES+TS

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

experimental: BES+sham TS

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Interventions

BES + TS

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Experimental: BES+sham TS

Blood Flow Restriction Enhanced Neuromuscular Electrical Stimulation (BES) sham treatment plus transspinal stimulation (TS) plus repetitive practice of task-specific activities, also known as massed practice (MP)

Primary outcome measure

  • Change in hand functional activities [ Time Frame: Baseline to 20 weeks ]
  • Change in maximum grip strength without TS [ Time Frame: Baseline to 20 weeks ]
  • Change in maximum grip strength with TS [ Time Frame: Baseline to 20 weeks ]
  • Change in electrical activity activation with TS [ Time Frame: Baseline to 20 weeks ]
  • Change in EMG activation without TS [ Time Frame: Baseline to 20 weeks ]
  • Change in tactile perception [ Time Frame: Baseline to 20 weeks ]

Central Contacts and Locations

Central contacts

Ashraf Gorgey, MPT, PhD, FACSM, FACRM

804-675-5000Ashraf.Gorgey@va.gov

Locations

Sheltering Arms Physical Rehabilitation Centers

Recruiting

Richmond, Virginia, United States, 23226

Richmond VA Medical Center

Recruiting

Richmond, Virginia, United States, 23249

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Spinal Cord Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-06.