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

Not Applicable

Completed

Conditions: Incomplete Spinal Cord Injury

Interventions: Device: Anodal tsDCS
Device: Cathodal tsDCS
Device: Sham tsDCS

Registration Number: NCT03249454

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 15

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS	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.
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS	Cathodal 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.
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS	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.
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS	Cathodal 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.
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS	Anodal 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.
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS	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.
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS	Anodal 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.
Cathode, then Anode, then Cathode, then Sham, then Anode tsDCS	Cathodal 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.
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS	Anodal 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.
Anode, then Cathode, then Anode, then Sham, then Cathode tsDCS	Anodal 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.
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS	Cathodal 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.
Sham, then Cathode, then Anode, then Anode, then Cathode tsDCS	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.
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS	Anodal 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.
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS	Anodal 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.
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS	Cathodal 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.
Anode, then Cathode, then Sham, then Anode, then Cathode tsDCS	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.
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS	Anodal 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.
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS	Cathodal 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.
Anode, then Anode, then Sham, then Cathode, then Cathode tsDCS	Cathodal 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.
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS	Anodal 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.
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS	Cathodal 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.
Cathode, then Anode, then Cathode, then Anode, then Sham tsDCS	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.
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS	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.
Sham, then Anode, then Cathode, then Cathode, then Anode tsDCS	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.
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS	Anodal 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.
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS	Cathodal 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.
Cathode, then Cathode, then Sham, then Anode, then Anode tsDCS	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.
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS	Anodal 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.
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS	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.
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS	Cathodal 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.
Sham, then Anode, then Cathode, then Anode, then Cathode tsDCS	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.
Anode, Then Cathode, Then Anode, Then Cathode Then Sham tsDCS	Cathodal 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.
Sham, Then Anode, Then Anode, Then Cathode, Then Cathode tsDCS	Anodal 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.

Primary Outcome Measures

Name	Time	Method
Change in Somatosensory Evoked Potential (SSEP)	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.
Percent Change in Hmax	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.

Secondary Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure	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
Change Systolic Blood Pressure	60 to 90 minutes before intervention, 60 to 90 minutes after intervention	Systolic Blood pressure will be recorded before and after each tsDCS session.
Change in Heart Rate	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