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Clinical Trials/NCT05472584
NCT05472584
Recruiting
N/A

Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury

Washington University School of Medicine1 site in 1 country120 target enrollmentJuly 21, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Washington University School of Medicine
Enrollment
120
Locations
1
Primary Endpoint
Motor evoked potentials amplitude and latency
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.

Detailed Description

The goal of this project is to determine the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits that are involved in SCS-mediated motor function improvements in individuals with spinal cord injury (SCI). The study will: (1) Determine the short-term effects in neural excitability induced by SCS and activity-based training. (2) Determine the effect of motor training on short-term changes in neural excitability enabled by SCS. (3) Determine the long-term changes in motor control and neural plasticity induced by combined SCS and activity-based training in individuals with chronic SCI. 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
July 21, 2023
End Date
August 2027
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
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 and 65 years old
  • Healthy people with no major comorbidities of any organ system

Exclusion Criteria

  • Healthy Volunteers
  • Subjects younger than 16 or older than 65 years old
  • Subjects not providing consent or not able to consent
  • Subjects with any acute or chronic pain condition
  • Subjects with any acute or chronic disease of a major organ system
  • Use of analgesics within 24 hours prior to study period
  • Use of caffeine with 3 hours of study appointment
  • Inclusion criteria:
  • Participants with spinal cord injury (SCI)
  • Age between 16-65 years old

Outcomes

Primary Outcomes

Motor evoked potentials amplitude and latency

Time Frame: 30 minutes before and 30 minutes after intervention; 4 weeks

This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation.

Reaction time to startle response

Time Frame: 30 minutes before and 30 minutes after intervention; 4 weeks

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.

F-wave response persistence

Time Frame: 30 minutes before and 30 minutes after intervention; 4 weeks

This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation.

Secondary Outcomes

  • Change in movement smoothness(Baseline, 30 minutes, and 4 weeks)
  • Changes in time to completion from baseline(Baseline, 30 minutes, and 4 weeks)

Study Sites (1)

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