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



Status:Recruiting
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:10/28/2018
Start Date:August 11, 2017
End Date:October 31, 2018
Contact:Radha Korupolu, MD
Email:Radha.Korupolu@uth.tmc.edu
Phone:713-797-5233

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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).

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 such as H reflex and somatosensory evoked potential (SSEP) wiil
be evaluated in subjects with SCI. This incremental, design will allow the establishment of
strong electrophysiological data prior to rapid clinical translation of the findings about
this promising, early-stage technique.

The central hypothesis is twofold: 1) active tsDCS will lead to a change in Hmax/M max ratio
than sham tsDCS, in a polarity dependent manner; and 2) active tsDCS will lead to a change in
SSEP amplitude and latency, in a polarity dependent manner.

Inclusion Criteria:

- Providing written informed consent prior to any study related procedures

- 18-50 years of age

- Motor incomplete SCI classified as 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)
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-797-5233
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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mi
from
Houston, TX
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