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

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).

Study Overview

• Status: Completed
• Conditions: Incomplete Spinal Cord Injury
• Intervention / Treatment: Device: Anodal tsDCS; Device: Cathodal tsDCS; Device: Sham tsDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

11

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 minutes before intervention, 10 minutes after intervention
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.	30 to 40 minutes before intervention, 30 to 40 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Systolic Blood Pressure	Systolic Blood pressure will be recorded before and after each tsDCS session.	60 to 90 minutes before intervention, 60 to 90 minutes after intervention
Change in Diastolic Blood Pressure	Diastolic Blood pressure will be recorded before and after delivering each intervention	60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)
Change in Heart Rate	Heart rate will be recorded before and after delivering each intervention	60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: TIRR/Mission Connect
• Investigators: Principal Investigator: Radha Korupolu, MD, The University of Texas Health Science Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 11, 2017
• Primary Completion (ACTUAL): October 26, 2018
• Study Completion (ACTUAL): October 26, 2018

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (ACTUAL): August 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Incomplete SCI
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: HSC-MS-17-0166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No