NCT05157282

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Detailed description

Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at improving limb function in humans with SCI (Taccola et al., 2018). Among current stimulation strategies, one of the most promising candidates to emerge in recent years is transcutaneous electrical spinal stimulation (TESS). TESS is a noninvasive technique that can be tailored to the needs of each individual, where several segments of the spinal cord can be stimulated at the same time, and delivery can be programed to interact with a rehabilitation strategy during functional movements, such as reaching or grasping. A key element to TESS is its ability to access spared spinal cord networks with minimal discomfort. Although promising, the knowledge of TESS remains limited in scope and more studies are needed to further identify its efficacy. In Aim 1, subjects will participate in two randomized sessions: 1) TESS, and 2) sham-TESS.\] In Aim 2, the investigators will examine the effect of stimulation and training for a total of 20 sessions (3 to 5 per week). Participants will be randomly assigned to: \[1) Closed-loop TESS applied during grasping + training, or 2) Closed-loop TESS applied during reaching + training.\] AIM 1 Subjects with SCI and without SCI (controls) will participate in two testing sessions, separated by 2-3 days, using a crossover design. In each session, TESS or sham-TESS will be applied over the cervical spinal cord. Functional and physiological measures will be acquired before and after each session. AIM 2 Develop methodologies to promote recovery of reaching and grasping movements. To accomplish this goal, the investigators will combine TESS applied in a closed-loop manner with massed practice upper-limb training. Participants will be assigned to one of three groups in a randomized order using a sham controlled design: \[1) Closed-loop TESS applied during grasping + training, 2) Closed-loop TESS applied during reaching + training, and 3) Closed-loop TESS applied during grasping \& reaching + training.\] TESS for 20-min will be followed by 60 min of massed practice exercise training (total=20 sessions).

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	TESS	Small stimulation pulses will be given to the spine at C5-6 in a non invasive manner.
OTHER	Training	The participant will be instructed to do repetitive motor movements with their arm or hand.
OTHER	Motor Task	Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
DEVICE	sham-TESS	Small sham stimulation pulses will be given to the spine at C5-6 in a non invasive manner.

Timeline

• Start date: 2023-01-25
• Primary completion: 2027-01-29
• Completion: 2027-02-01
• First posted: 2021-12-14
• Last updated: 2026-01-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study