Burke Medical Research Institute
White Plains, New York, 10605, United States
NCT Number: NCT03592173
The purpose of this study is to determine if spinal excitability is increased with a Spinal Associative Stimulation (SAS) protocol, and to determine the functional consequences of this technique on motor recovery.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Interventional
Phase 2
White Plains, New York, 10605, United States
Recovery of motor function continues to be a problem following Spinal Cord Injury. Non-invasive brain stimulation techniques, targeting cortical areas, have been shown to enhance the excitability in the human motor cortex, and these changes in the motor cortex may be of significance for the rehabilitation of brain injured patients. However, little is known about the adaptational changes in the excitability/plasticity of spinal neural circuits in spinal cord injury patients.
The purpose of this study is to investigate the excitability of cortical and spinal inhibitory and excitatory mechanisms before and following a period of repetitive and synchronized dual peripheral nerve and brain stimulation. Repetitive, paired brain and peripheral nerve stimulation as a neuromodulatory tool, paired associative stimulation (PAS), has been well described. In this technique, stimuli are timed such that afferent and efferent volleys interact at the level of the cortex, that lead to a temporary enhancement of Motor Evoked Potential (MEP) amplitude in target muscles, and when applied repeatedly, lead to a sustained effect, outlasting the intervention period. This repetitive technique has been done in healthy subjects and patients with neurological diseases. By modifying the time between paired stimuli, the investigators will generate afferent/efferent interactions in the spinal cord.
The working hypothesis of this study is that the acute facilitation of the H-reflex during Paired TMS and peripheral nerve stimulation, may be harnessed to modulate spinal excitability (sustained increase in the MEP amplitude). That is, the investigators will test if similar to PAS, a change in excitability outlasting the stimulation/intervention period may occur with afferent/efferent interactions, although at the level of the spinal cord rather than the cortex, and be useful to strengthen residual pathways after damage to the spinal cord.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Potential TMS risk factor:
Method of assessing neurophysiology and activity of the spinal cord
Time frame: Baseline compared with immediately after intervention
Assessment of muscle reaction after stimulation of sensory fibers
Time frame: Baseline, immediately after intervention
Assessment of lower extremity strength in key muscles; maximal score of 50 with 20 or less indicating participant likely has limited ambulation.
Time frame: Baseline, immediately after intervention
This is a functional capacity scale that rank orders ambulation in people with spinal cord injury, by evaluating the amount of physical assistance, braces or devices required to walk 10 meters. Rank scores range from 0-20. A higher score is indicative of more independent ambulation.
Time frame: Baseline, immediately after intervention
Measure of gait speed
Time frame: Baseline, immediately after intervention
A disability rating scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently (including self-care, mobility, respiration and sphincter management)
Time frame: Baseline, immediately after intervention
Amount of force recorded during maximal voluntary isometric contraction of a grip movement, recorded with a grip strength measurement device.
Time frame: Baseline, immediately after intervention
Lower extremity robotic device that provides kinematic evaluation data
Kathleen Friel
Other
Non-Invasive Stimulation for Improving Motor Function in Spinal Cord Injury
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