Neural Facilitation of Movements in People With SCI

Not Applicable

Terminated

Conditions: Spinal Cord Injuries

Interventions: Other: Electrophysiology assessment - corticospinal tract
Other: Electrophysiology assessment - reticulospinal tract
Other: Training with some stimulation

Registration Number: NCT05354206

Lead Sponsor: Washington University School of Medicine

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements	Electrophysiology assessment - corticospinal tract	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.
Reaction time evaluation during non-invasive spinal cord stimulation and leg movements	Training with some stimulation	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
Reaction time evaluation during non-invasive spinal cord stimulation and leg movements	Electrophysiology assessment - reticulospinal tract	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
Evaluation of motor evoked potentials during non-invasive spinal cord stimulation and leg movements	Training with some stimulation	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.

Primary Outcome Measures

Name	Time	Method
Changes in Corticospinal Tract Excitability After Training	30 minutes before and 30 minutes into intervention	This primary outcome is a measure of changes in corticospinal tract excitability as quantified by changes in the amplitude size of motor evoked potentials. Data for this arm were not collected due to early study termination.
Reticulospinal Tract Excitability During Different Types of Movements	During intervention, 1 Day.	This primary outcome measures changes in reticulospinal tract excitability (RST) during training as quantified by changes in reaction time after a startling auditory stimulus. RST contrubution was evaluated for dorsiflexion, plantarflexion, hip flexion movements during precision and range of motion control tasks under three conditions: with transcutaneous spinal cord stimulation or without stimulation. All conditions/evaluations were performed in the same session. 30 repetitions were performed per condition during a single session and averaged for each participant. RST is a ratio calculated by = (visual - startle)/(visual - auditory), where: visual represents the reaction time to a visual cue, auditory represents the reaction time to an auditory cue, startle represents the reaction time to a startling cue. A RST ratio value greater than 1 would indicate a significant contribution of the reticulospinal tract for a given task. A value equal or lower than 1 would suggest