NCT07607665

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
70mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026May 2032

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2031

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2032

Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

4.9 years

First QC Date

May 19, 2026

Last Update Submit

May 26, 2026

Conditions

Hemiplegic Cerebral Palsy

Keywords

cervical spinal cordspinal cord associative plasticitySCAPcorticospinalmanual dexteritycerebral palsymotor evoked potentialhemiplegiaadults with CPsensorysomatosensation

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 minutes after intervention

  • 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.

    30 minutes after intervention

Study Arms (1)

Paired brain and nerve stimulation

EXPERIMENTAL

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

Paired brain and nerve stimulationDEVICE

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

Paired brain and nerve stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10040, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 31889474BACKGROUND

  • 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.

    PMID: 29616203BACKGROUND

  • 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.

    PMID: 36063483BACKGROUND

  • 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.

    PMID: 10686179BACKGROUND

  • 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.

    PMID: 38758005BACKGROUND

  • 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.

    PMID: 41106070BACKGROUND

  • 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.

    PMID: 28053760BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Carmel, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaker Dukkipati, MD, PhD

CONTACT

2123046501sd3850@cumc.columbia.edu

Jason Carmel, MD, PhD

CONTACT

jbc28@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Weinberg Family Associate Professor of Neurology (in Orthopedic Surgery); Chief of the Division of Child Neurology

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2032

Last Updated

May 28, 2026

Record last verified: 2026-05

Locations

US(1)