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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249454
Recruitment Status : Completed
First Posted : August 15, 2017
Results First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
TIRR/Mission Connect
Information provided by (Responsible Party):
Radha Korupolu, The University of Texas Health Science Center, Houston

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).

Condition or disease Intervention/treatment Phase
Incomplete Spinal Cord Injury Device: Anodal tsDCS Device: Cathodal tsDCS Device: Sham tsDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
Actual Study Start Date : August 11, 2017
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Percent Change in Hmax [ Time Frame: 10 minutes before intervention, 10 minutes after intervention ]
    Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.

  2. Change in Somatosensory Evoked Potential (SSEP) [ Time Frame: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention ]
    A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.


Secondary Outcome Measures :
  1. Change Systolic Blood Pressure [ Time Frame: 60 to 90 minutes before intervention, 60 to 90 minutes after intervention ]
    Systolic Blood pressure will be recorded before and after each tsDCS session.

  2. Change in Diastolic Blood Pressure [ Time Frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) ]
    Diastolic Blood pressure will be recorded before and after delivering each intervention

  3. Change in Heart Rate [ Time Frame: 60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention) ]
    Heart rate will be recorded before and after delivering each intervention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249454


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
TIRR/Mission Connect
Investigators
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Principal Investigator: Radha Korupolu, MD The University of Texas Health Science Center
  Study Documents (Full-Text)

Documents provided by Radha Korupolu, The University of Texas Health Science Center, Houston:
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Responsible Party: Radha Korupolu, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03249454    
Other Study ID Numbers: HSC-MS-17-0166
First Posted: August 15, 2017    Key Record Dates
Results First Posted: February 13, 2020
Last Update Posted: February 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radha Korupolu, The University of Texas Health Science Center, Houston:
Incomplete SCI
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System