Actively Recruiting
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Led by Virginia Commonwealth University · Updated on 2025-07-01
44
Participants Needed
3
Research Sites
219 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A written clearance from a study medical doctor confirming safe participation
- Must have a companion available to assist throughout the study
- More than 1 year since spinal cord injury at neurologic level C8 or above
- American Spinal Injury Association Impairment Scale (AIS) score of B, C, or D indicating incomplete SCI
- Visible muscle contraction response to neuromuscular electrical stimulation of wrist extensors on both sides
- Agreement to use telehealth services with required technology including webcam, computer, microphone, speakers, high-speed internet, valid email, and telephone
- Muscle contraction response of wrist extensors bilaterally to neuromuscular electrical stimulation
You will not qualify if you...
- Unhealed fractures in upper or lower limbs
- Severe scoliosis, severe upper extremity contractures, or other musculoskeletal issues preventing participation or valid outcome evaluation
- High resting blood pressure greater than 140/80 mmHg
- Use of anticoagulant or antiplatelet medications, including aspirin if cannot be stopped for medical reasons
- Pregnancy (female participants), with monthly pregnancy tests during the study
- Implanted pacemakers or defibrillator devices
- Presence of implanted electrical devices, cancer, thrombosis, seizures, or use of anticoagulant/antiplatelet medications
- Any condition judged by study doctors to preclude safe participation
- Uncontrolled autonomic dysreflexia
- Severe neurological injuries other than spinal cord injury, such as MS, cerebral palsy, severe traumatic brain injury, or stroke
- Unresolved deep vein thrombosis
- Psychiatric or cognitive impairments preventing adherence
- Known cardiac diseases precluding safe participation
- Metabolic conditions like cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, or insulin use
- Stage three or greater pressure sores
- Symptomatic urinary tract infection
- Severe spasticity assessed by the Modified Ashworth Scale
- Changing neurologic status due to progressive conditions like posttraumatic syringomyelia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sheltering Arms Physical Rehabilitation Centers
Richmond, Virginia, United States, 23226
Actively Recruiting
2
Richmond VA Medical Center
Richmond, Virginia, United States, 23249
Actively Recruiting
3
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
Research Team
A
Ashraf Gorgey, MPT, PhD, FACSM, FACRM
CONTACT
R
Refka Khalil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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