Neural Facilitation of Movements in People With SCI

Study Overview
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Brief Summary
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Spinal cord injury leads to long-lasting paralysis and impairment. Re-enabling movement of paralyzed areas is challenging and more information is needed about neurological recovery. The purpose of this study is to understand the contribution of individual neural tracts to movements facilitated by transcutaneous spinal cord stimulation (SCS).

Detailed Description
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Spinal cord injury leads to long-lasting motor impairment and paralysis that currently is not curable. Electrical spinal cord stimulation (SCS) is beginning to be used as a neuromodulation technique to re-enable movement of paralyzed areas, however the mechanisms of neurorecovery induced by electrical neuromodulation of the spinal cord remain poorly understood. The goal of this project is to generate evidence-based knowledge of changes in the short-term excitability of corticospinal and reticulospinal neural structures that may mediate immediate improvements in motor function enabled by SCS. The proposed study will: (1) determine which kinds of SCS-facilitated movements are mediated by the corticospinal tract. (2) determine which kinds of SCS-facilitated movements are mediated by the reticulospinal tract. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.

Official Title
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Neural Facilitation of Stimulation-assisted Movements in People With Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Electrophysiology assessment - corticospinal tract
* Other: Electrophysiology assessment - reticulospinal tract
* Other: Training with some stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers Age between 16-65 Healthy individuals with no major conditions of any organ system Exclusion Criteria: Healthy volunteers Not willing or able to provide consent Any acute or chronic pain condition Any acute or chronic disease of a major organ system Use of analgesics within 24 hours prior to study appointment Use of caffeine with 3 hours of study appointment History of epilepsy Implanted metal Active medical problems Inclusion criteria: Participants with spinal cord injury (SCI) Age between 16-65 Traumatic SCI C4-T9 level, complete (ASIA A) or incomplete (ASIA B, C or D) at least 1 year post injury Stable medical condition difficulty independently performing leg movements in routine activities able to follow simple commands able to speak and respond to questions Exclusion criteria: Participants with spinal cord injury (SCI) Not willing or able to provide consent Any acute or chronic pain condition Any acute or chronic disease of a major organ system Use of analgesics within 24 hours prior to study appointment Use of caffeine with 3 hours of study appointment Presence of tremors, spasms and other significant involuntary movements Etiology of SCI other than trauma Concomitant neurologic disease such as traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy) History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc). Severe joint contractures disabling or restricting lower limb movements. Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities Depression, anxiety, or cognitive impairment Deficit of visuo-spatial orientation Sitting tolerance less than 1 hour Severe hearing or visual deficiency Miss more than 3 appointments without notification Unable to comply with any of the procedures in the protocol Botulinum toxin injection in lower extremity muscles in the prior six months Any passive implants (osteosynthesis material, metallic plates or screws) below T9. Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.) History of alcoholism or another drug abuse Pregnancy (or possible pregnancy) Having an Intrathecal Baclofen Therapy Pump (ITB pump) History of epilepsy

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After baseline evaluations of the effect of transcutaneous SCS on single pulse responses, motor function, and a familiarization phase on a body-machine interface, participants will be randomly assigned to one of two arms in the study. Arm 1: Participants will receive intervention A during the initial phase of the study and intervention B during the second phase of the study. Arm 2: Participants will receive intervention B during the initial phase of the study and intervention A during the second phase of the study. In both interventions A and B, participants will use their legs to control a computer cursor as transcutaneous spinal cord stimulation is delivered. In intervention A, the investigators will use transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract during the movement tasks. In intervention B, the investigators will use loud auditory stimuli to evaluate the excitability of the reticulospinal tract during the movement tasks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements<br>This arm will receive the transcranial magnetic stimulation to evaluate the excitability of the corticospinal tract first then the arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal track second. | Other: Electrophysiology assessment - corticospinal tract<br>* Kinematics and cortical spinal motor excitability<br>Other: Training with some stimulation<br>* Motor task combined with real or sham stimulation<br>|
| Experimental: Reaction time evaluation during non-invasive spinal cord stimulation and leg movements<br>This arm will receive the loud auditory stimuli to evaluate the excitability of the reticulospinal tract first then the arm will receive the transcranial magnetic stimulation to excite the corticospinal tract second | Other: Electrophysiology assessment - reticulospinal tract<br>* Kinematics and reticular spinal motor excitability<br>Other: Training with some stimulation<br>* Motor task combined with real or sham stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in corticospinal tract excitability after training | This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. | 30 minutes before and 30 minutes into intervention | 
| Changes in reticulospinal tract excitability after training | This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus. | 30 minutes before and 30 minutes into intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, spinal cord injury, spinal cord stimulation, neuromodulation