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Behavioural Intervention
Brain + Spinal Cord Stimulation for Spinal Cord Injury
N/A
Waitlist Available
Led By Noam Y Harel, MD, PhD
Research Sponsored by Bronx VA Medical Center
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 change immediately after procedure
Awards & highlights
Study Summary
This trial aims to help people with spinal cord injuries improve arm and hand function with a combination of brain and spinal cord stimulation.
Who is the study for?
This trial is for adults aged 18-75 with chronic cervical spinal cord injury (SCI) levels C1-C8, who have some arm/hand muscle function. Able-bodied individuals can also participate. Exclusions include multiple SCI lesions, seizure history, ventilator use, severe head trauma, implanted stimulators or metallic implants, significant heart disease, psychosis or heavy alcohol use recently.Check my eligibility
What is being tested?
The study tests if combining brain stimulation (TMS) with different placements of spinal cord stimulation (tsDCS - coronal/caudal/rostral) improves arm and hand functions in those with chronic cervical SCI. It aims to strengthen remaining connections in the corticospinal tract.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, dizziness or nausea during treatment. There's a low risk of seizures due to brain stimulation but participants are screened for this risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change immediately after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change immediately after procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor evoked potential (MEP) amplitudes
Secondary outcome measures
H-reflex amplitudes
Intracortical inhibition and facilitation
Muscle dynamometry
Trial Design
3Treatment groups
Experimental Treatment
Group I: Rostral tsDCSExperimental Treatment2 Interventions
DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly
Group II: Coronal tsDCSExperimental Treatment1 Intervention
DCS cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.
Group III: Caudal tsDCSExperimental Treatment2 Interventions
DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcutaneous spinal direct current stimulation (tsDCS) - rostral
2021
N/A
~30
transcutaneous spinal direct current stimulation (tsDCS) - coronal
2021
N/A
~30
transcutaneous spinal direct current stimulation (tsDCS) - caudal
2021
N/A
~30
intermittent theta burst stimulation (iTBS)
2021
N/A
~70
Find a Location
Who is running the clinical trial?
Bronx VA Medical CenterLead Sponsor
20 Previous Clinical Trials
1,262 Total Patients Enrolled
New York State Department of HealthOTHER_GOV
34 Previous Clinical Trials
447,073 Total Patients Enrolled
Noam Y Harel, MD, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
4 Previous Clinical Trials
49 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with spinal cord injuries.Participants must be physically able to participate.You have consumed a lot of alcohol (more than 5 shots of liquor) in the past 48 hours.You have had bipolar disorder in the past.You have had a stroke, brain tumor, or brain abscess in the past.You have more than one lesion on your spinal cord.You have had seizures in the past.You need a ventilator or have a tube in your throat.You have had a serious head injury in the past.You have a serious heart condition related to your arteries or heart rhythm.You have tried to harm yourself on purpose in the past.You have ongoing severe mental health issues, such as hallucinations or delusions.You have open sores on your face, neck, shoulders, or arms.You are between 18 and 75 years old and do not have any known brain or spinal cord conditions or injuries.You are between 18 and 75 years old and have had a spinal cord injury for more than 12 months, between the neck levels C1-C8, and have limited strength in specific hand muscles.You are taking certain medications that can increase the risk of having seizures.You have experienced sudden increases in blood pressure without a change in heart rate and have symptoms like headache, facial flushing, sweating, nasal congestion, and blurry vision in the past 6 months.You need to be between 18 and 75 years old.You have weakness in certain muscles when tested by a doctor.You don't have any known problems with your brain or nerves.
Research Study Groups:
This trial has the following groups:- Group 1: Rostral tsDCS
- Group 2: Caudal tsDCS
- Group 3: Coronal tsDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
James J. Peters Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- James J. Peters Veterans Affairs Medical Center: < 48 hours
Average response time
- < 2 Days
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