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Completed

NCT Number: NCT03249454

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Anodal tsDCS

Device

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.

Cathodal tsDCS

Device

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.

SHAM tsDCS

Device

During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • TIRR/Mission Connect

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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