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Behavioural Intervention

Brain-Spinal Cord-Muscle Response Training for Spinal Cord Injury

N/A

Recruiting

Led By Aiko K Thompson, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Signs of weak ankle dorsiflexion at least unilaterally

Neurologically stable (>1 year post SCI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 3 months post intervention

Awards & highlights

Study Summary

This trial is testing whether a brain-spinal cord-muscle response training program can improve movement control in people who have had a spinal cord injury.

Who is the study for?

This trial is for individuals with spinal cord injury who can move at least 10 meters with or without help, have weak ankle movement, and are stable on their current medications. They should be over a year post-injury and neurologically stable. People with severe heart conditions, cognitive impairments, seizures, metal head implants, no muscle response in tests, daily leg stimulation therapy or pregnancy cannot participate.Check my eligibility

What is being tested?

The study examines how brain-spinal cord-muscle response training can improve control of movements after a spinal cord injury. Participants will undergo sessions involving standing, sitting and walking while being monitored through electrodes on the legs and non-painful transcranial magnetic stimulation over the head.See study design

What are the potential side effects?

While there's little to no discomfort expected from the transcranial magnetic stimulation used to examine brain-to-muscle connections during this study; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have weakness in lifting my foot or toes upward on at least one side.

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My spinal cord injury has been stable for over a year.

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I can walk at least 10 meters with or without help, but not using parallel bars.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 3 months post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 3 months post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in excitability of the excitability of the brain as measured by Short Interval Intra-cortical Inhibition (SICI)

Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Studied Leg

H-Reflex

+6 more

Secondary outcome measures

Body Weight Changes

Change in excitability/strength of the spinal cord-muscle pathway as measured by Change in F-wave amplitude (mV) and F-wave occurrence (out of 30 trials) in response to nerve stimulation--Contralateral Leg

Change in hip joint motion during walking (deg)--Both Legs

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Up-conditioning (UC) GroupExperimental Treatment1 Intervention

Group II: Control (NC) GroupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Operant Conditioning

2022

N/A

~30

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

649,315 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,591 Total Patients Enrolled

Aiko K Thompson, PhDPrincipal InvestigatorMedical University of South Carolina

1 Previous Clinical Trials

40 Total Patients Enrolled

Media Library

Spasticity Research Study Groups: Up-conditioning (UC) Group, Control (NC) Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary goals of this research endeavor?

"This medical trial will be monitored from baseline to 3 months post intervention in order to gauge the change of excitability/strength between the brain, spinal cord and leg muscles. The primary objective is assessing this relationship at the studied leg while secondary objectives involve evaluating changes in ankle joint motion during walking; maximum MEP size (mV); peak flexion angle (in deg); contact angle with ground (in deg) as well as reorganization of the tibialis anterior muscle's cortical map on contralateral legs. Ultimately, these data points help researchers better understand the potential impact of operant conditioning training methods."

Answered by AI

Are any new participants being enrolled in this research study?

"Affirmative, according to the clinicaltrials.gov website this trial is still open and actively recruiting. The initial posting date was February 22nd 2021, with a recent update occurring October 15th of the same year. 44 participants are needed from 1 site for successful completion of the study."

Answered by AI

How many patients is this experiment accommodating?

"Affirmative. Records on clinicaltrials.gov demonstrate that this experiment is currently recruiting individuals, having first been posted on February 22nd 2021 and last updated October 15th 2021. 44 participants are required to be admitted at a single centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physiological Changes Induced Through MEP Conditioning in People With SCI

Aiko Thompson 2021. "Physiological Changes Induced Through MEP Conditioning in People With SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04286191.

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