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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
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.
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.
During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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.
Time frame: 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.
Time frame: 30 to 40 minutes before intervention, 30 to 40 minutes after intervention
Change Systolic Blood Pressure
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
Change in Diastolic Blood Pressure
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)
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Change in Heart Rate
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)