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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment at minute 0, minute 10, minute30, minute 60.
Awards & highlights

Study 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.

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
1,609 Previous Clinical Trials
3,306,254 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

Frequently Asked Questions

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

How many participants have signed up for this research trial?

"Indeed, the information hosted on clinicaltrials.gov suggests that enrollment is currently available for this medical trial which was initially posted on March 17th 2020 and most recently updated on March 4th 2022. 175 individuals will be admitted to a single site."

Answered by AI

Are there vacant slots in the experiment for volunteers?

"According to the current information hosted on clinicaltrials.gov, this research is actively looking for participants as of 3/4/2022. It was initially listed back in March 17th 2020."

Answered by AI

Is there an opportunity to join this medical research endeavor?

"This clinical trial is looking to recruit 175 participants with spinal cord injuries that possess a range of characteristics. These include, but are not limited to: the ability to create precision grips bilaterally, visible grip force when using one hand, being between 18 and 85 years old in age, right-handedness and an ASIA classification of A through D."

Answered by AI

Is this clinical trial open to those who are under thirty years of age?

"In order to be eligible for enrollment in this clinical trial, participants must between the ages of 18 and 85."

Answered by AI

Who else is applying?

What site did they apply to?
Edward Hines Jr. VA Hospital, Hines, IL
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I have been a SCI patient since 2006. I broke C-6/C-7 and damaged (punctured) my spinal cord. I am tetraplegic with Brown Sicard - left arm/hand and right leg and foot paralyzed. Around January of 2023 I started losing strength and dexterity and had scar tissue grow to the top of my C-5 vertebrae causing C-5 Cervical Myelopathy. My left shoulder became a neuropathic shoulder and is slowly dying. My right hand has lost pretty most of its grip strength, but I am still able to move all fingers and thumb. I can no longer walk with a cane because grip loss, I use a rollator for short distances and wheelchair for long distances. I lost my live-in girlfriend in November of 2022 and I am currently trying to live by myself.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 1 Day
Most responsive sites:
  1. Edward Hines Jr. VA Hospital, Hines, IL: < 24 hours
~7 spots leftby Jun 2024