CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Soterix Medical tsDCS stimulator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03702842
NCT03702842N/ACompleted

Transcutaneous Spinal Direct Current Stimulation to Enhance Locomotion After Spinal Cord Injury

University of Florida·interventional·Posted Oct 11, 2018·Updated Mar 13, 2025

In Brief

A clinical study evaluating Soterix Medical tsDCS stimulator and Locomotor training for SCI - Spinal Cord Injury and Incomplete Spinal Cord Injury. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This pilot study will investigate the effects of transcutaneous direct current stimulation (tsDCS) on walking function in individuals with incomplete spinal cord injury. Following rehabilitation, individuals with ISCI often demonstrate improved walking function, but continue to have serious impairments that limit mobility, community participation and quality of life. Adjuvants to rehabilitation that increase spinal excitation during training may enhance its effectiveness. tsDCS is a non-invasive neuromodulation approach that uses a mild electrical current, applied over the skin of the low back, to alter the membrane potential of spinal neurons. tsDCS will be applied during locomotor training, a well-established rehabilitation strategy that promotes walking recovery. Locomotor training emphasizes repetitive and task-specific practice of coordinated walking, often with therapist assistance or cueing to promote high quality movement patterns. The study team will explore if tsDCS combined with locomotor training increases spinal excitation and thereby improves the effectiveness of walking rehabilitation.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 11, 2018
Enrollment StartApr 1, 2019
Primary CompletionSep 2, 2021
Study CompletionSep 5, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.7 years ago

Interventions

Soterix Medical tsDCS stimulatordevice

tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.

Locomotor trainingother

Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.