Status:
COMPLETED
Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
TIRR/Mission Connect
Conditions:
Incomplete Spinal Cord Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ch...
Detailed Description
The purpose of the study is to investigate the effects of a novel therapeutic approach to promote functional recovery and spasticity in chronic SCI. The tsDCS effect on neuro-physiological measures su...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03249454
Start Date
August 11 2017
End Date
October 26 2018
Last Update
February 13 2020
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030