NCT06886152

Spinal Stimulation and Gait Training to Improve Mobility in TBI

Transcutaneous Spinal Stimulation and Gait Training to Improve Mobility and Motor Control in Individuals With Traumatic Brain Injury

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to assess the effects of receiving transcutaneous spinal stimulation while performing walking exercises compared to completing walking exercises without spinal stimulation for individuals with hemiplegic TBI.

Detailed description

The fundamental hypothesis guiding this proposal is that transcutaneous spinal cord stimulation combined with gait training for individuals with hemiplegic TBI will lead to improved: modulation of corticospinal networks, functional mobility, gait symmetry, standing posture, balance, and motor efficiency compared to gait training with sham stimulation.

Conditions

• Traumatic Brain Injury
• Traumatic Brain Injury (TBI)
• Hemiplegia and Hemiparesis

Interventions

Type	Name	Description
PROCEDURE	Transcutaneous Spinal Cord Stimulation	A portable transcutaneous spine stimulator (Digitimer ®, USA) will supply biphasic stimulation superficial to the thoracolumbar spine.
OTHER	Sham	A portable transcutaneous spine stimulator (Digitimer ®, USA) will be applied superficially with no electrical current.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2025-03-20
• Last updated: 2025-09-02

Locations

2 sites across 1 country: United States