N/A N=4 Randomized Treatment

Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI

Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT02862080 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session — -3.13 percent change in H-Reflex

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: cathode tsDCS (Device); Ekso (Device); anode tsDCS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Nov 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session	-3.13	—
PRIMARY Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session	-2.30; -7.44; -9.82	—
PRIMARY Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session	-2.30; -7.44; -9.82	—
PRIMARY Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session	-2.30; -7.44; -9.82	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—
SECONDARY Gait Speed as Assessed by 10 Meter Walk Test	39.38; 35.35; 26.43	—

Summary

The purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsDCS) is safe for individuals with spinal cord injury (SCI). tsDCS is an electrical current applied to the skin. The plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with SCI after combined application of tsDCS and exoskeleton assisted gait training.

Eligibility Criteria

Inclusion Criteria

Male or non-pregnant female
≥18 years of age
Able to achieve adequate fit within exoskeleton
Diagnosis of spinal cord injury (SCI), T10 level and above (T11 and 12 may participate if no clinical signs of lower motor neuron lesion present)
Minimum of 6 months post injury
Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit
Weight 10° at hips, knees or ankles)
Uncontrolled autonomic dysreflexia
Unresolved deep vein thrombosis
Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension
Severe comorbidities: active infections, heart, lung, or circulatory conditions
Pressure sores, impaired skin integrity
Use of mechanical ventilation for respiratory support
Presence of any of the following contraindications to electrical stimulation: cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) tissue
Presence of metal in thoracic spine or region of electrode placement

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02862080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.