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

Primary Purpose

Incomplete Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anodal tsDCS
Cathodal tsDCS
Sham tsDCS
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Incomplete SCI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS

Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS

Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS

Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS

Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS

Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS

Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS

Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS

Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS

Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS

Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percent Change in Hmax
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.
Change in Somatosensory Evoked Potential (SSEP)
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

Change Systolic Blood Pressure
Systolic Blood pressure will be recorded before and after each tsDCS session.
Change in Diastolic Blood Pressure
Diastolic Blood pressure will be recorded before and after delivering each intervention
Change in Heart Rate
Heart rate will be recorded before and after delivering each intervention

Full Information

First Posted
August 2, 2017
Last Updated
January 27, 2020
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
TIRR/Mission Connect
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1. Study Identification

Unique Protocol Identification Number
NCT03249454
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
TIRR/Mission Connect

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury
Keywords
Incomplete SCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover design with 9 arms: Anodal tsDCS, Cathodal tsDCS, Sham tsDCS
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Anodal tsDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cathodal tsDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham tsDCS
Intervention Description
During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
Primary Outcome Measure Information:
Title
Percent Change in Hmax
Description
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.
Time Frame
10 minutes before intervention, 10 minutes after intervention
Title
Change in Somatosensory Evoked Potential (SSEP)
Description
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.
Time Frame
30 to 40 minutes before intervention, 30 to 40 minutes after intervention
Secondary Outcome Measure Information:
Title
Change Systolic Blood Pressure
Description
Systolic Blood pressure will be recorded before and after each tsDCS session.
Time Frame
60 to 90 minutes before intervention, 60 to 90 minutes after intervention
Title
Change in Diastolic Blood Pressure
Description
Diastolic Blood pressure will be recorded before and after delivering each intervention
Time Frame
60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Title
Change in Heart Rate
Description
Heart rate will be recorded before and after delivering each intervention
Time Frame
60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radha Korupolu, MD
Organizational Affiliation
The University of Texas Health Science Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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