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Clinical Trials/NCT05354206
NCT05354206
Terminated
Not Applicable

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

Washington University School of Medicine1 site in 1 country20 target enrollmentJune 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Washington University School of Medicine
Enrollment
20
Locations
1
Primary Endpoint
Changes in Corticospinal Tract Excitability After Training
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2022
End Date
March 6, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ismael Seáñez

Assistant Professor of Biomedical Engineering and Neurosurgery

Washington University School of Medicine

Eligibility Criteria

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:

Outcomes

Primary Outcomes

Changes in Corticospinal Tract Excitability After Training

Time Frame: 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

Time Frame: 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

Study Sites (1)

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