Neural Facilitation of Movements in People With SCI

October 2, 2024 updated by: Ismael Seáñez, Washington University School of Medicine

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63105
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • 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
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
Kinematics and cortical spinal motor excitability
Other: Training with some stimulation
Motor task combined with real or sham stimulation
Experimental: Reaction time evaluation during non-invasive spinal cord stimulation and leg movements
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: Training with some stimulation
Motor task combined with real or sham stimulation
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minutes before and 30 minutes into intervention
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
During intervention, *1 Day*.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Ismael Seanez, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2022

Primary Completion (Actual)

March 6, 2023

Study Completion (Actual)

March 6, 2023

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202111151

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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