ClinicalTrials.gg
RecruitingNCT07607665SCAP-CPUpdated Sep 14, 2026

Spinal Cord Associative Plasticity in Cerebral Palsy

An interventional study of Paired brain and nerve stimulation in Hemiplegic Cerebral Palsy, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Columbia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Hemiplegic Cerebral Palsy

Keywords

  • cervical spinal cord
  • spinal cord associative plasticity
  • SCAP
  • corticospinal
  • manual dexterity
  • cerebral palsy
  • motor evoked potential
  • hemiplegia
  • adults with CP
  • sensory
  • somatosensation
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 25 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of seizures in last two years
  • Use of medications that lower seizure threshold
  • History of implanted equipment including stimulators/pacemakers
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Paired brain and nerve stimulation

    With this session, participants will receive paired motor cortical stimulation and median nerve stimulation at sub-threshold intensities, timed to converge in the cervical spinal cord simultaneously.

    Device: Paired brain and nerve stimulation

Interventions

  • DevicePaired brain and nerve stimulation

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

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 30 minutes after intervention

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

    Time frame: 30 minutes after intervention

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Ling YT, Alam M, Zheng YP. Spinal Cord Injury: Lessons about Neuroplasticity from Paired Associative Stimulation. Neuroscientist. 2020 Jun;26(3):266-277. doi: 10.1177/1073858419895461. Epub 2019 Dec 31. PubMed 31889474 ↗
  • Gillick BT, Gordon AM, Feyma T, Krach LE, Carmel J, Rich TL, Bleyenheuft Y, Friel K. Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide. Front Pediatr. 2018 Mar 16;6:56. doi: 10.3389/fped.2018.00056. eCollection 2018. PubMed 29616203 ↗
  • Pal A, Park H, Ramamurthy A, Asan AS, Bethea T, Johnkutty M, Carmel JB. Spinal cord associative plasticity improves forelimb sensorimotor function after cervical injury. Brain. 2022 Dec 19;145(12):4531-4544. doi: 10.1093/brain/awac235. PubMed 36063483 ↗
  • Stefan K, Kunesch E, Cohen LG, Benecke R, Classen J. Induction of plasticity in the human motor cortex by paired associative stimulation. Brain. 2000 Mar;123 Pt 3:572-84. doi: 10.1093/brain/123.3.572. PubMed 10686179 ↗
  • McIntosh JR, Joiner EF, Goldberg JL, Greenwald P, Dionne AC, Murray LM, Thuet E, Modik O, Shelkov E, Lombardi JM, Sardar ZM, Lehman RA, Chan AK, Riew KD, Harel NY, Virk MS, Mandigo C, Carmel JB. Timing-dependent synergies between motor cortex and posterior spinal stimulation in humans. J Physiol. 2024 Jun;602(12):2961-2983. doi: 10.1113/JP286183. Epub 2024 May 17. PubMed 38758005 ↗
  • Murray LM, McIntosh JR, Goldsmith JA, Wu YK, Liu M, Sanford SP, Joiner EF, Mandigo C, Tyagi V, Virk MS, Carmel JB, Harel NY. Timing-dependent synergies between noninvasive motor cortex and spinal cord stimulation in chronic cervical spinal cord injury. Clin Neurophysiol. 2025 Dec;180:2111372. doi: 10.1016/j.clinph.2025.2111372. Epub 2025 Oct 10. PubMed 41106070 ↗
  • Shulga A, Lioumis P, Zubareva A, Brandstack N, Kuusela L, Kirveskari E, Savolainen S, Ylinen A, Makela JP. Long-term paired associative stimulation can restore voluntary control over paralyzed muscles in incomplete chronic spinal cord injury patients. Spinal Cord Ser Cases. 2016 Jul 14;2:16016. doi: 10.1038/scsandc.2016.16. eCollection 2016. PubMed 28053760 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07607665
Responsible party
Jason Carmel (Weinberg Family Associate Professor of Neurology (in Orthopedic Surgery); Chief of the Division of Child Neurology, Columbia University) — Principal investigator
First posted
May 26, 2026
Start date
Jul 27, 2026
Primary completion
May 2031 (estimated)
Completion
May 2032 (estimated)
Last update
Sep 14, 2026

Study contacts

Shaker Dukkipati, MD, PhD
Contact
sd3850@cumc.columbia.edu
2123046501
Jason Carmel, MD, PhD
Contact
jbc28@cumc.columbia.edu
Jason Carmel, MD, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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