25 Participants NeededMy employer runs this trial

Paired Brain and Nerve Stimulation for Cerebral Palsy

(SCAP-CP Trial)

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 using paired brain and nerve stimulation to help adults with hemiplegic cerebral palsy (hCP) improve arm and hand movement. The goal is to determine if this method can strengthen nervous system connections to enhance manual dexterity. Participants should maintain their usual levels of caffeine and exercise, have some ability to use their hands, and not have had recent seizures or use certain medications. If successful, researchers could test this approach further in larger studies. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could lead to innovative treatments for hCP.

Do I need 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 on such medications, you may need to stop taking them to participate.

What prior data suggests that this paired brain and nerve stimulation is safe for adults with hemiplegic cerebral palsy?

Research shows that combining brain and nerve stimulation is generally safe and well-tolerated for people with cerebral palsy. Studies have found that a similar method, non-invasive brain stimulation (NIBS), can safely improve movement and function in children with cerebral palsy. These studies indicate that NIBS is not only safe but also effective in enhancing mobility and upper body function.

Previous research on non-invasive brain stimulation techniques did not show any major side effects. This suggests that the treatment is unlikely to cause harm when used at low levels, where stimulation remains below the threshold that typically causes a reaction.

While this trial does not list specific side effects, the treatment's similarity to other safe non-invasive methods offers reassurance. Prospective participants might find this information helpful in feeling more comfortable about the safety of the treatment being tested.12345

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral palsy, which typically include physical therapy, medication, and sometimes surgery, the paired brain and nerve stimulation technique offers a novel approach by directly targeting the brain and nerves. This method involves synchronized stimulation of the motor cortex and median nerve, aiming to improve motor function by enhancing neural connections in the cervical spinal cord. Researchers are excited about this treatment because it represents a non-invasive option that potentially promotes more precise and effective brain-to-muscle communication, which could lead to improved motor skills for individuals with cerebral palsy.

What evidence suggests that paired brain and nerve stimulation is effective for cerebral palsy?

Research has shown that combining brain and nerve stimulation may enhance movement and hand use in individuals with cerebral palsy. In this trial, participants will receive paired motor cortical stimulation and median nerve stimulation. Studies have found that non-invasive brain stimulation can boost motor skills, reduce muscle stiffness, and enhance hand movement. Tests measuring movement ability support these findings. Early evidence suggests this treatment could be safe and practical for improving arm and hand function in cerebral palsy. Although more research in adults is needed, these promising results offer hope for a better quality of life.14678

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 adults diagnosed with hemiplegic cerebral palsy (hCP) who want to improve arm and hand function. Participants should be able to take part in brain and nerve stimulation sessions. People with other major health issues or conditions that could interfere with the study may not be eligible.

Inclusion Criteria

My hand function is classified as MACS level I, II, or III.
Maintenance of caffeine and exercise levels at time of sessions
Ability to provide informed consent

Exclusion Criteria

I have had seizures in the past two years.
I am taking medications that may increase my risk of seizures.
History of implanted equipment including stimulators or pacemakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive paired motor cortical and median nerve stimulation at sub-threshold intensities, timed to converge in the cervical spinal cord

Duration not specified
1 session

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of muscle response and dexterity improvements

30 minutes after intervention

What Are the Treatments Tested in This Trial?

Interventions

  • Paired brain and nerve stimulation

Trial Overview

The study tests paired electrical stimulation of the brain's motor area and a nerve in the arm, aiming to boost connections in the spinal cord and improve hand dexterity. The effects will be measured using physical tests and clinical assessments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Paired brain and nerve stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

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Results showed that NIBS could safely and effectively improve mobility in children with CP, as demonstrated by improvements in 6MWT, key gait ...

Spinal Cord Associative Plasticity in Cerebral Palsy

The study hypothesis is that pairing stimulation of the hand motor cortex with median nerve stimulation will produce associative plasticity in ...

Non-invasive brain stimulation for upper extremity dysfunction ...

Our findings suggest for the first time that tDCS is effective in improving spasticity (MAS), and hand fine motor function, especially hand ...

Safety and efficacy of non‐invasive brain stimulation for the ...

Evidence indicates that NIBS is a safe and feasible intervention to target upper extremity outcomes in children with CP, although it also ...

Effectiveness of neurofeedback interventions in cerebral ...

Reported benefits included improvements in brain activity, motor outcomes, and cognitive functions. However, not all studies confirmed these ...

Paired Non-invasive VNS in Adolescent Cerebral Palsy ...

This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) ...

Infancy through young adulthood - Brain Stimulation

SAFETY AND OUTCOMES OF PEDIATRIC NEUROMODULATION IN. CEREBRAL PALSY: INFANCY ... Keywords: Non-invasive brain stimulation, Cerebral Palsy, Pediatrics,.

Safety and efficacy of non-invasive brain stimulation for the ...

Interpretation: Evidence indicates that NIBS is a safe and feasible intervention to target upper extremity outcomes in children with CP, ...