Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury



Status:Recruiting
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:7/8/2018
Start Date:May 2016
End Date:May 2019
Contact:Nuray Yozbatiran, PhD
Email:Nuray.Yozbatiran@uth.tmc.edu
Phone:713-797-5282

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Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)

This study will compare different polarities of transcutaneous spinal direct current
stimulation combined with robotic-assisted arm training in adults with acquired brain injury
(ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham
transpinal direct current stimulation (tsDCS) over cervical spine combined with high
intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Acquired brain injury (ABI) is the leading cause of neurological disability in the United
States and accounts for the poor physical health and the social dysfunction evident in
survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and
arm paresis is perceived as the primary cause of disability by individuals who have suffered
ABI because of the limitations it creates in performing activities of daily living (ADL).
Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet
only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for
upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from
upper limb paresis and only 18% of these individuals gain full motor recovery with
conventional treatments in the year following ABI.

The study will use cross-over, randomized, sham controlled, double-blinded design in which 10
participants with subacute or chronic ABI will be assigned to receive either active anodal
spinal stimulation, cathodal spinal stimulation, and sham spinal stimulation experiments for
the same duration in a random order. In all the experiments participants will receive robotic
assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled
with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per
week for 2 weeks.

Inclusion Criteria:

1. Providing written informed consent prior to any study related procedures;

2. Age above 18;

3. Diagnosis of acquired brain injury at least for 6 month

4. No neuropsychiatric comorbidities

5. Not being involved in any specific exercise program (e.g., neuromuscular electrical
stimulation (NMES), functional electrical stimulation (FES)) within the previous 3
months;

6. No planned alteration in upper-extremity therapy or medication for muscle tone during
the course of the study;

7. Eligibility for standard upper-extremity rehabilitation at the time of enrollment
(i.e., absence medical comorbidities that would prevent standard rehabilitation);

8. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with
valid administration of the measures or with interpreting motor testing;

9. No contraindications to tsDCS:

- metal in the head between stimulation area

- metal in the spine between stimulation area

- implanted brain medical devices

10. No pregnancy;

11. No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic
resonance imaging (MRI) based on TMS and MRI screening forms

Exclusion Criteria:

1. Uncontrolled epilepsy;

2. Any joint contracture or severe spasticity in the affected upper extremity, as
measured by a Modified Ashworth Score > than 3 out of 4;

3. History of substance abuse;

4. Subject who cannot provide self-transportation to the study location
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Houston, TX
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