N/A N=13 Randomized Triple-blind Treatment

Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury

Incomplete Spinal Cord Injury

Bottom Line

View on ClinicalTrials.gov: NCT03249454 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Feb 2020

Primary outcome: Primary: Percent Change in Hmax — 27.85; 8.43; -4.91; 16.20 percent change in Hmax

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Anodal tsDCS (Device); Cathodal tsDCS (Device); Sham tsDCS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Hmax	27.85; 8.43; -4.91; 16.20; -3.99; 34.04	—
PRIMARY Change in Somatosensory Evoked Potential (SSEP)	—	—
SECONDARY Change Systolic Blood Pressure	7.90; 7.58; -4.00	—
SECONDARY Change in Diastolic Blood Pressure	4.80; 2.16; -0.44	—
SECONDARY Change in Heart Rate	-7.35; -6.53; -4.78	—

Summary

The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI).

Eligibility Criteria

Inclusion Criteria

Providing written informed consent prior to any study related procedures
18-65 years of age
Motor incomplete SCI classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS)
Traumatic lesion at or above T8-T9 neurological level
Body mass index ≤ 30 (in order to facilitate reliable location of body landmarks guiding stimulation);
Chronic SCI (time since injury>6 months)

Exclusion Criteria

Unstable cardiopulmonary conditions
History of seizure, head injury with loss of consciousness, severe alcohol or drug abuse, and/or psychiatric illness
Any joint contracture or severe spasticity, as measured by a Modified Ashworth Score 4
Subject who cannot provide self-transportation to the study location
Cardiac or neural pacemakers
Pregnancy
lower motor neuron injury (eg: peripheral neuropathy, cauda equina syndrome)
Uncontrolled diabetes with HbA1C>7
History of severe autonomic dysreflexia
No planned alteration in therapy or medication for muscle tone during the course of the study(No botulinum toxin injections in last 3 months, No phenol injections in last 6 months, intrathecal baclofen pump dose stable for past 3 months, etc)
Conditions for e.g., severe arthritis, extreme shoulder pain that would interfere with valid administration of the measures or with interpreting motor testing;
No contraindications to tsDCS
ferromagnetic material in the brain or in the spine (except for titanium used in segmental)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03249454). 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.