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Brain Stimulation + Motor Training for Spinal Cord Injury

N/A
Recruiting
Led By Monica A Perez, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease, Any debilitating disease prior to the SCI that caused exercise intolerance, Premorbid, ongoing major depression or psychosis, altered cognitive status, History of head injury or stroke, Pacemaker, Metal plate in skull, History of seizures, Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, Pregnant females, Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, MS, or herniated disk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment at minute 0, minute 10, minute30, minute 60.
Awards & highlights

Summary

This trial will study how best to help people with cervical spinal cord injuries regain grasping ability through non-invasive brain stimulation, motor training, and other methods.

Who is the study for?
This trial is for right-handed adults aged 18-85, both healthy and those with chronic spinal cord injury (SCI) at C8 or above. Healthy participants must be able to grip and move their wrists. SCI participants need some wrist movement and the ability to grip, but can't join if they have uncontrolled medical issues, a history of severe mental health problems, head injury or stroke, pacemakers, metal in the skull, seizure history, certain medications lowering seizure threshold or are pregnant.Check my eligibility
What is being tested?
The study tests how brain stimulation (iTMS) combined with motor tasks affects grasping function after cervical SCI. Participants will practice precision and power grips while receiving either real iTMS or a sham treatment without actual stimulation. The goal is to see if this combination improves hand function.See study design
What are the potential side effects?
Potential side effects from iTMS may include discomfort at the stimulation site on the scalp, headache, lightheadedness or seizures although rare. Training might cause muscle fatigue or soreness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have uncontrolled health issues or a history of major mental health, head injury, stroke, seizures, or specific spinal cord diseases.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post treatment at minute 0, minute 10, minute30, minute 60.
This trial's timeline: 3 weeks for screening, Varies for treatment, and post treatment at minute 0, minute 10, minute30, minute 60. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in amplitude of Motor evoked potential size
Secondary outcome measures
Grip Strength and 9-hole peg test

Trial Design

3Treatment groups
Active Control
Group I: Experiment 1bActive Control2 Interventions
To accomplish this aim the investigators propose to complete one main experiment. The investigators will use iTMS and/or an acoustic startle stimuli to test the hypothesis that induced-plasticity protocols (iTMS and startle stimuli) will enhance EMG and force output in hand muscles during grasping. In a randomized sham crossover design, SCI and controls will be assigned to two groups: (1) iTMS applied during precision and power grip (two randomized sessions), and (2) startle applied during precision and power grip (two randomized sessions).
Group II: Experiment 2Active Control4 Interventions
To accomplish this aim the investigators propose to complete one main experiment. The investigators will combine iTMS and/or acoustic startle with precision and power grip training to test the hypothesis that 'precision and power grip training outcomes will be enhanced by iTMS and startle induced plasticity'. In a randomized sham controlled design, SCI and control subjects will be assigned to: training+iTMS and training+sham iTMS and training+startle and training+sham startle.
Group III: Experiment 1aActive Control2 Interventions
Examine physiological mechanisms contributing to the control of precision and power grip behaviors. To accomplish this aim the investigators propose to complete one main experiment. The investigators will test the hypotheses that there are two fundamentally distinct modes of hand operation after SCI. One involves brainstem pathways, and permits whole-hand 'power grip', while the other involves corticospinal and motor cortical connections, and allows a wide range of fractionated finger movements (precision grip) after SCI. Measurements of corticospinal, reticulospinal, and motoneuron excitability will be tested during index finger abduction, precision and power grip.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,804 Total Patients Enrolled
Monica A Perez, PhDPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
3 Previous Clinical Trials
188 Total Patients Enrolled

Media Library

Experiment 1b Clinical Trial Eligibility Overview. Trial Name: NCT03447509 — N/A
Spinal Cord Injury Research Study Groups: Experiment 1b, Experiment 2, Experiment 1a
Spinal Cord Injury Clinical Trial 2023: Experiment 1b Highlights & Side Effects. Trial Name: NCT03447509 — N/A
Experiment 1b 2023 Treatment Timeline for Medical Study. Trial Name: NCT03447509 — N/A
~33 spots leftby Jul 2025
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