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Behavioural Intervention
Spinal Cord Stimulation for Spinal Cord Injury (SCAP Trial)
N/A
Recruiting
Led By Jason B Carmel, M.D., Ph.D.
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-80 years
Clinical indication for cervical spine surgery (INTRA-OPERATIVE)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes after scap
Awards & highlights
SCAP Trial Summary
This trial will study whether electrical stimulation of the spinal cord can improve its function.
Who is the study for?
This trial is for adults aged 18-80 with spinal cord injuries or cervical myelopathy who may undergo surgery. Able-bodied participants without neurological diseases can join too. Participants must not use certain drugs, have a history of seizures, metal implants in the head (except dental), stimulators, or severe cardiovascular issues.Check my eligibility
What is being tested?
The study tests SCAP—a technique using electrical stimulation on the brain and spine to improve arm and hand function after spinal injury. It explores if this can strengthen muscle signaling and enhance movement production by the spinal cord before or during surgery.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but could include discomfort from electrical stimulation, temporary muscle twitching, skin irritation at electrode sites, and in rare cases, an increased risk of seizures due to cortical stimulation.
SCAP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
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I am scheduled for surgery on my neck's spine.
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I do not have any known neurological diseases or injuries.
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My hand muscles are partially weak but can still move.
SCAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after scap
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after scap
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Size of hand muscle response to brain stimulation after SCAP
Size of hand muscle response to brain stimulation during combined brain and spinal stimulation
Secondary outcome measures
Amplitudes of H-reflex ratio
Amplitudes of H-reflex ratio (lasting)
Duration of effect of SCAP on subsequent responses to brain or spinal cord stimulation
+7 moreSCAP Trial Design
5Treatment groups
Experimental Treatment
Group I: 5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic regionExperimental Treatment2 Interventions
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP) at or below myelopathic region.
Group II: 4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAPExperimental Treatment1 Intervention
Participants with chronic cervical SCI will take part in the following, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Group III: 3. Intraoperative participants - Lasting effects of SCAPExperimental Treatment2 Interventions
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery, to examine the lasting effects of repeated cortical and spinal stimulation: A) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP); B) Intraoperative repeated pairing of cortical and spinal stimulation (SCAP).
Group IV: 2. Intraoperative participants - Immediate effects of paired stimulationExperimental Treatment2 Interventions
Participants will take part in the following if they have been scheduled for a clinically indicated cervical surgery to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Intraoperative pairing of cortical and spinal stimulation.
Group V: 1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulationExperimental Treatment2 Interventions
Participants will take part in the following to examine the immediate effects of combining cortical and spinal stimulation: A) Non-invasive pairing of cortical and spinal stimulation; B) Non-invasive repeated pairing of cortical and spinal stimulation (SCAP).
Find a Location
Who is running the clinical trial?
Bronx Veterans Medical Research Foundation, IncOTHER
9 Previous Clinical Trials
689 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,432 Previous Clinical Trials
2,460,881 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,217 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I or my family have a history of seizures.You have had major hearing issues in the past.I have a serious heart condition.You have stents in the blood vessels of your neck or brain.I have a medical device implanted or a condition that doesn't allow brain or spine stimulation.I am not taking medications like amphetamines or bupropion that increase my risk of seizures.I am between 18 and 80 years old.I rely on a ventilator to breathe or have an open tracheostomy.You have consumed a lot of alcohol (more than 5 shots of liquor) in the past two days.I am scheduled for surgery on my neck's spine.I have had repeated episodes of autonomic dysreflexia in the last 6 months.I have epilepsy.You have had a serious head injury in the past.You currently have severe mental health issues that affect your thoughts and behavior.I do not have any known neurological diseases or injuries.You have had a serious problem with drugs or alcohol within the past year, or significant mental or emotional issues.I have open skin wounds on my face, neck, shoulders, or arms.I have a history of stroke, brain tumor, brain abscess, or multiple sclerosis.I have had a recent heart attack or heart failure with severe limitations.You have a stimulation device in your neck or chest, such as a pacemaker, that could interfere with the experiment involving spinal cord stimulation.My hand muscles are partially weak but can still move.You have a cochlear implant and the study involves stimulating the brain.You have skull fragments in your head (for experiments involving brain stimulation).I have had skull surgery with metal implants.My medication has not changed in the last 30 days.You have tried to harm yourself in the past.You have been diagnosed with bipolar disorder in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 3. Intraoperative participants - Lasting effects of SCAP
- Group 2: 1. Uninjured participants - Immediate and lasting effects of non-invasive paired stimulation
- Group 3: 2. Intraoperative participants - Immediate effects of paired stimulation
- Group 4: 4. Chronic cervical SCI participants - Lasting effects of non-invasive SCAP
- Group 5: 5. Intraoperative participants - Lasting effects of SCAP at or below myelopathic region
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.
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05163639 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is the intended target demographic for this clinical experiment?
"This clinical trial seeks 92 participants who are between 18 and 80 years of age, possess spinal cord diseases, and meet the following criteria: able-bodied; no history of invasive procedures; 30 days stable with prescription medication prior to screening; abstain from alcohol, smoking, caffeine consumption on day of experiment as well as recreational drugs for entirety of study; commit to seven visits required by protocol; provide informed consent. For patients diagnosed with SCI including those scheduled for intraoperative procedure must have a manual muscle testing score ranging between 1-4 out of 5 in finger extension/flexion or abduction in either left or right hand."
Answered by AI
Does the eligibility criteria include individuals under 35 years old?
"Participants of this medical trial must be under 80 years old and have attained the legal age of consent."
Answered by AI
What key objectives is this clinical trial attempting to achieve?
"This clinical trial, which will be closely monitored over a short period of time, is aiming to measure the hand muscle response to brain stimulation after SCAP. Secondary objectives include quantifying pinch opposition strength between thumb and third finger with a handheld dynamometer, recording force and root mean square (RMS) for electromyographic activity, comparing maximal pinch dynamometry results to baseline measurements, using H-reflex amplitudes as biomarkers for spasticity triggered by 1.0 ms pulses along the median nerve at the elbow, and determining threshold voltage necessary to trigger muscle response from cortical electrical stimulation."
Answered by AI
What is the aggregate tally of participants enrolled in this experiment?
"Yes, according to clinicaltrials.gov, this experiment is actively petitioning 92 patients from 4 distinct sites. It was initially posted on September 10th 2021 and has been updated recently on June 1st 2022."
Answered by AI
Are there any recruitment opportunities for participants in this research?
"Affirmative, the clinical trial is currently enrolling patients. As per information on clinicaltrials.gov, this medical study was first published on September 10th 2021 and last updated on June 1st 2022. They are actively looking for 92 people from 4 sites to participate in this research."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Columbia University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have daily extreme 24 hour pain. In 1986 I was thrown from a jeep, it flew through the air, rolled several times and landed on top of me upside down crushing my entire body but one leg. Through the years i have tried alternative meds, accupuncture, light therapy pads, pain meds, narcotics, yoga, exercise as much as i can as well as extreme diet changes. And, yet i still struggle. Please help me.
PatientReceived 2+ prior treatments
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