Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Experimental
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
5 tsDCS sessions were performed for each subject, with at least a 1 week washout period between tsDCS sessions. For each session, the subject was randomly assigned to cathodal, anodal or sham tsDCS. Each subject who completed the study received 2 cathodal, 2 anodal and 1 sham tsDCS session.
  • Device: Anodal tsDCS
    During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Cathodal tsDCS
    During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
  • Device: Sham tsDCS
    During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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.

Notice

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