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Behavioural Intervention

Spinal Cord Stimulation for Spinal Cord Injury (SCAP Trial)

Phase < 1

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)

Must not have

Personal or extensive family history of seizures

Significant coronary artery or cardiac conduction disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes after scap

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

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

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I or my family have a history of seizures.

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I have a serious heart condition.

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I have a medical device implanted or a condition that doesn't allow brain or spine stimulation.

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I am not taking medications like amphetamines or bupropion that increase my risk of seizures.

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I rely on a ventilator to breathe or have an open tracheostomy.

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I have open skin wounds on my face, neck, shoulders, or arms.

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I have a history of stroke, brain tumor, brain abscess, or multiple sclerosis.

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I have had a recent heart attack or heart failure with severe limitations.

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I have had skull surgery with metal implants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after scap

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after scap

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after scap for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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).

0 / 13Eligibility criteria met