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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)

Must not have

Motoneuron injury

Medically unstable condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 3 months post intervention

Awards & highlights

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a motor neuron injury.

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I have a condition that makes my health unstable.

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I have a history of epileptic seizures.

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I have metal implants in my head.

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I am not pregnant.

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I have difficulty with memory or thinking clearly.

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I have a known heart condition.

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I use electrical stimulation on my leg every day.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,362 Previous Clinical Trials

650,706 Total Patients Enrolled

Medical University of South CarolinaLead Sponsor

960 Previous Clinical Trials

7,399,516 Total Patients Enrolled

Aiko K Thompson, PhDPrincipal InvestigatorMedical University of South Carolina

1 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

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

~2 spots leftby Nov 2024

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