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

Incomplete Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249454
• Other study ID #: HSC-MS-17-0166
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: October 26, 2018

Study information

• Verified date: January 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	TIRR/Mission Connect

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)