NCT03714282

Noninvasive Spinal Stimulation in Stroke

Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

Detailed description

OBJECTIVES: * To determine whether transcutaneous spinal cord stimulation combined with ambulation training modulates corticospinal locomotor networks in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves locomotor function in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves symmetry of gait in individuals with chronic hemiplegic stroke * To determine whether transcutaneous spinal stimulation combined with ambulation training improves standing posture and balance in individuals with chronic hemiplegic stroke * To determine whether ambulation efficiency (improved cardiovascular conditioning) improves with transcutaneous non-invasive spinal stimulation and locomotor training in individuals with chronic hemiplegic stroke

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Noninvasive spinal stimulation with gait training	Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
DEVICE	Conventional gait training	May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.

Timeline

• Start date: 2018-10-18
• Primary completion: 2020-05-14
• Completion: 2020-05-14
• First posted: 2018-10-22
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study