20 Participants NeededMy employer runs this trial

SCAP-Nerve Protocol for Spinal Cord Plasticity

SD
JC
Overseen ByJason Carmel, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach called the SCAP-Nerve protocol, which aims to improve hand movement and dexterity. By pairing gentle electrical stimulation of the brain and a nerve in the arm, researchers aim to encourage the spinal cord to adapt and enhance motor function. The trial seeks typically developing adults without neurological or musculoskeletal issues in their arms or hands, who are willing to attend up to four sessions. The results could eventually benefit those with spinal cord injuries or cerebral palsy. As an unphased trial, participants have a unique opportunity to contribute to groundbreaking research that could lead to significant advancements in treatment options.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use medications that lower the seizure threshold. If you are taking such medications, you may need to stop them to participate.

What prior data suggests that the SCAP-Nerve protocol is safe for inducing spinal cord plasticity?

Research has shown that the SCAP-Nerve protocol, which uses brain and spinal cord stimulation, is under evaluation for safety and its potential to improve hand and arm movement. Studies have found that noninvasive methods like this typically have manageable side effects. The protocol employs gentle electrical signals to enhance communication between the spinal cord and brain, aiding recovery with minimal discomfort.

Researchers are studying the protocol to ensure the stimulation is safe and effective. Early results are promising, with no serious side effects reported in similar studies. However, since this study is in its early stages and involves healthy adults, monitoring for any side effects is crucial before broader application.12345

Why are researchers excited about this trial?

Researchers are excited about the SCAP-Nerve Protocol because it aims to enhance spinal cord plasticity using a novel combination of paired motor cortical and median nerve stimulation. Unlike traditional treatments that often focus on medication or physical therapy to manage symptoms, this protocol targets the spinal cord directly to potentially restore function through precise timing of nerve stimulations. By synchronizing these stimulations, the protocol hopes to promote more effective neural connections, offering a new avenue for improving mobility and recovery in patients.

What evidence suggests that the SCAP-Nerve protocol could be effective for promoting spinal cord plasticity?

This trial will compare different stimulation methods to assess their impact on movement abilities. Research has shown that combining brain and nerve stimulation, as in the SCAP-Nerve method, can enhance movement abilities. Participants in the SCAP arm will receive paired motor cortical and median nerve stimulation, timed to converge in the spinal cord. Early results suggest that when these stimulations meet in the spinal cord rather than the brain, they lead to stronger arm movements. This method relies on "plasticity," meaning the spinal cord can change and improve over time. Previous studies have demonstrated that similar techniques can significantly enhance motor skills by promoting this adaptability. This approach could address movement issues, potentially benefiting individuals with spinal cord injuries or cerebral palsy.678910

Who Is on the Research Team?

JC

Jason Carmel, MD, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for healthy adults with no neurological or musculoskeletal problems in their arms or hands, who are willing to attend up to 4 sessions and keep their caffeine and exercise habits the same during the study.

Inclusion Criteria

* Willingness to participate in up to 4 sessions
* Maintenance of caffeine and exercise levels at time of sessions
* Ability to provide informed consent
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 90 trials of paired motor cortical and median nerve stimulation for 15 minutes at sub-threshold intensities, timed to converge in the cervical spinal cord

Single session
1 visit (in-person)

Follow-up

Participants are monitored for physiological and behavioral effects of the SCAP protocol

30 minutes
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • SCAP-Nerve protocol

Trial Overview

Researchers are testing a new paired stimulation technique (SCAP-Nerve protocol) that combines mild brain and nerve stimulation using devices like Digitimer DS8R and MagPro X100. The goal is to see if this method can improve hand movement by targeting the cervical spinal cord.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: SCAPExperimental Treatment1 Intervention
Group II: Median nerve stimulation onlyActive Control1 Intervention
Group III: Cortical stimulation onlyActive Control1 Intervention
Group IV: Paired non-associative stimulationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

Real-World Outcomes of Spinal Cord Stimulation - PMC

Among the 505 patients who underwent SCS trials, the overall trial success rate was 86.1%, with 435 patients experiencing at least 50% pain ...

Spinal Cord Stimulation Real-World Outcomes: A 24-Month ...

Conclusions: In this real-world cohort, SCS therapy results in sustained, clinically significant improvements in pain, neuropathic symptoms, and ...

Spinal Cord Stimulation vs Medical Management for ...

Results showed that patients treated with either conventional or novel SCS had better functionality than patients treated with CMM, with ...

Spinal Cord Stimulation for Pain Management Following ...

In our review, all included studies demonstrated some degree of pain improvement following SCS, with 8 studies reporting a ≥30% improvement in pain; a commonly ...

A systematic review of evidence comparing spinal cord ...

The primary outcome was ≥50% pain reduction in low back pain at 6 months. In the SCS group, 14% (95% CI: 7–20%) vs. 5% (95% CI: 1–9%) in ...

Spinal Cord Associative Plasticity Study

Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand ...

Spinal Cord Associative Plasticity Study (SCAP) - BINA

This study seeks to improve arm and hand function in individuals with spinal cord injury. Noninvasive stimulation to both the brain and spinal cord.

Cervical Spinal Cord Associative Plasticity

This N/A medical study run by Columbia University is evaluating whether SCAP-Nerve protocol will have tolerable side effects & efficacy for ...

Spinal Cord Associative Plasticity (SCAP)

We are testing different combinations of magnetic and electrical brain and spinal cord stimulation to see if we can improve hand function by activating spared ...

Cervical Spinal Cord Associative Plasticity

This study will first be conducted in typically developing adults to confirm the cervical spinal cord as the ideal target and verify the present ...