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NCT Number: NCT07607665

Spinal Cord Associative Plasticity in Cerebral Palsy

Associative plasticity has been used to promote functional recovery from conditions affecting movement. The long term goal of this project is to use electrical stimulation techniques to improve arm and hand function. The goal of this prospective experimental study in adults with hemiplegic cerebral palsy (hCP) is to test the effects of pairing hand motor cortical and median nerve stimulation targeted to induce plasticity in the cervical spinal cord. Based on preliminary data in neurotypical adults, the investigators are testing the effects of this approach in adults with hCP.

This study will first verify the present stimulation parameters as sufficient to promote induction of associative plasticity of sensorimotor connections for manual dexterity in adults with hCP. This will be assessed through neurophysiological, biomechanical, and clinical functional outcome measures. Successful pairing showing meaningful improvements in dexterity could then be used as an impetus for a larger study examining the efficacy of SCAP in people with hCP.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10040, United States

Location status: Recruiting

Location contact

Jason Carmel, MD, PhD

CONTACT

[email protected]

Shaker Dukkipati, MD, PhD

CONTACT

[email protected]

2123046501

About this study

Associative plasticity has been used to promote functional recovery in patient populations, such as adults with spinal cord injuries (SCI). Using safe and well-tolerated non-invasive neuromodulation approaches, pairing of motor cortical stimulation and peripheral nerve stimulation has been shown to augment motor responses and promote plasticity, primarily through the convergence of sensory afferent stimuli and descending cortical stimuli in the motor cortex.

Our laboratory has shown that paired associative stimulation timed to converge in the cervical spinal cord induces significantly larger upper limb motor responses than if timed to converge in the motor cortex. While paired associative stimulation has shown promise for strengthening motor responses, it is unclear if plasticity from convergence of non-invasive stimuli in the spinal cord (termed spinal cord associative plasticity or SCAP) instead of the motor cortex can produce greater motor effects, and potentially greater promotion of movement recovery.

The goal of this present study is to test the effects of pairing sub-threshold hand motor cortical and median nerve stimulation targeted to induce plasticity in the cervical spinal cord of adults with hemiplegic cerebral palsy. The investigators aim to fill a knowledge gap regarding the ideal target of non-invasive stimulation to maximize associative plasticity for upper limb movement recovery. The study hypothesis is that pairing stimulation of the hand motor cortex with median nerve stimulation will produce associative plasticity in the cervical spinal cord measured through augmentation of motor responses in upper limb muscles, leading to improvements in dexterity.

This study will first verify that the present stimulation parameters are sufficient to promote induction of associative plasticity of sensorimotor connections for manual dexterity. The outcomes from this study could be translated to an efficacy study in people with CP to test whether pairing brain and afferent-targeted nerve stimulation for convergence in the cervical spinal cord can lead to clinically meaningful improvements in manual dexterity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maintenance of caffeine and exercise levels at time of sessions
  • Ability to provide informed consent
  • Manual ability classification system (MACS) level I to III

Exclusion criteria

  • History of seizures in last two years
  • Use of medications that lower seizure threshold
  • History of implanted equipment including stimulators/pacemakers

Treatment and study plan

Paired brain and nerve stimulation

Device

This utilizes pairing of repetitive transcranial magnetic stimulation (rTMS) and peripheral nerve stimulation (rPNS) timed to converge in the cervical spinal cord.

Primary outcomes

  1. Size of muscle response to brain stimulation after intervention (percentage)

    Time frame: 30 minutes after intervention

    Size of muscle response will be measured in response to brain stimulation. This value will be normalized to the equivalent measure taken before the SCAP protocol.

  2. Number of blocks moved during box and blocks testing (BBT) after intervention

    Time frame: 30 minutes after intervention

    Number of blocks moved during box and blocks testing will be measured after SCAP protocol. This value will be normalized to the equivalent measure taken before the SCAP protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Carmel, MD, PhD

CONTACT

[email protected]

Shaker Dukkipati, MD, PhD

CONTACT

[email protected]

2123046501

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Paired Stimulation of Hand Motor Cortex and Median Nerve to Induce Spinal Cord Plasticity in Hemiplegic Cerebral Palsy

Acronym: SCAP-CP

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
May 26, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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