Clinical trial NCT03249454: Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Official title: Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: Incomplete SCI
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: TIRR/Mission Connect
First posted: 2017-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
Primary purpose: TREATMENT

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 chronic spinal cord injury (SCI).

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 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.

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)

Primary outcomes:
measure: Percent Change in Hmax
timeFrame: 10 minutes before intervention, 10 minutes after intervention
measure: Change in Somatosensory Evoked Potential (SSEP)
timeFrame: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention
Secondary outcomes:
measure: Change Systolic Blood Pressure
timeFrame: 60 to 90 minutes before intervention, 60 to 90 minutes after intervention
measure: Change in Diastolic Blood Pressure
timeFrame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
measure: Change in Heart Rate
timeFrame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center
name: Radha Korupolu, MD
role: PRINCIPAL_INVESTIGATOR
References: