NCT05423600

Transspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cervical spinal cord injury (cSCI) results in physical impairment and limited mobility, with the most severe cSCI necessitating wheelchair use for ambulation and impaired upper extremity function resulting in subsequent chronic comorbidities. These comorbidities may include psychosocial, cardiovascular, metabolic and respiratory consequences, as well as a significant socioeconomic burden. The economic burdens for persons with cSCI, their families, and society are increasing at an alarming rate, especially with decreasing mortality due to advances in medical interventions. Restoring some degree of upper extremity and hand function would improve overall functional ability and quality of life. Through physical rehabilitation, upper extremity function can improve, but gains are limited for people with the most severe, motor-complete cSCI. Attempts have been made to restore and improve upper extremity and hand function using implanted epidural stimulation of the cervical spinal cord, but alternatives to this invasive therapy are warranted to maximize the amount of people who may benefit from enhanced motor activation. The total study duration is 30 weeks. The first 4 weeks will start and end with baseline assessments (Baseline 1 \&2). The rest of this 4-week period will consist of 2 sessions/week of education and optimization provided to the participant and a caregiver, to instruct them to use the TS device and blood pressure machine and carry out massed practice training for both groups. The first two weeks of this 4-week phase will occur onsite in the laboratory, and the second two weeks of this 4-week phase will occur at home via telehealth to familiarize participants and companions with the telehealth platform - however, if the participant and companion desire more on-site instruction, they may come into the lab to do this during this time as well. Following the first 4-week phase, 16 weeks of 3 sessions/week of BES+TS or BES+sham TS training at home with supervision from the research team via telehealth will occur. In the week following completion of the intervention, post-intervention outcome measures assessments will take place. There will then be an 8-week washout period where participants will receive no training. Following the 8-week washout, participants will be asked to come back to the lab for one more follow-up assessment of outcome measures to test any long-term effects of the intervention.

Conditions

• Tetraplegia/Tetraparesis

Interventions

Type	Name	Description
PROCEDURE	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)
PROCEDURE	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)

Timeline

• Start date: 2022-06-15
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-06-21
• Last updated: 2025-07-01

Locations

3 sites across 1 country: United States