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

Completed · Not applicable · Has a placebo group

Conditions studied: Incomplete Spinal Cord Injury

In brief

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).

Key facts

Study ID

NCT03249454

Run by

The University of Texas Health Science Center, Houston

People needed

15

Starts

2017-08-11

Expected to finish

2018-10-26

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• The University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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