Hemiplegic Cerebral PalsySCAP-CPNCT07607665
Spinal Cord Associative Plasticity in Cerebral Palsy
A study testing Paired brain and nerve stimulation in people with Hemiplegic Cerebral Palsy, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Paired brain and nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to May 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance of caffeine and exercise levels at time of sessions
- Ability to provide informed consent
- Manual ability classification system (MACS) level I to III
Who cannot join
- History of seizures in last two years
- Use of medications that lower seizure threshold
- History of implanted equipment including stimulators/pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jason Carmel, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10040
Shaker Dukkipati, MD, PhD, 2123046501, sd3850@cumc.columbia.edu
Jason Carmel, MD, PhD, jbc28@cumc.columbia.edu
About this study
Official title: Paired Stimulation of Hand Motor Cortex and Median Nerve to Induce Spinal Cord Plasticity in Hemiplegic 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.
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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Paired brain and nerve stimulation
- Keywords
- cervical spinal cord, spinal cord associative plasticity, SCAP, corticospinal, manual dexterity, cerebral palsy, motor evoked potential, hemiplegia, adults with CP, sensory, somatosensation
- Medical subject headings
- Cerebral Palsy, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Paired brain and nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start27 Jul 2026
- Primary completionMay 2031 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Carmel, Columbia University
- Investigators
- Jason Carmel, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607665
- Sponsor's protocol ID
- AAAV2760-CP
- Acronym
- SCAP-CP
- Status last verified
- Sep 2026
- First submitted
- 19 May 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
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 31889474Gillick 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 29616203Pal 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 36063483Stefan 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 10686179McIntosh 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 38758005Murray 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 41106070Shulga 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Stimulation of Hand Motor Cortex and Median Nerve to Induce Spinal Cord Plasticity in Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07607665
- Acronym / sponsor ID
- SCAP-CP / AAAV2760-CP
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- cervical spinal cord, spinal cord associative plasticity, SCAP, corticospinal, manual dexterity, cerebral palsy, motor evoked potential, hemiplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paired brain and nerve stimulation | Experimental | Device: Paired brain and nerve stimulationWith 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Maintenance of caffeine and exercise levels at time of sessions
- Ability to provide informed consent
- Manual ability classification system (MACS) level I to III
Key exclusion criteria (3 listed)
- History of seizures in last two years
- Use of medications that lower seizure threshold
- History of implanted equipment including stimulators/pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paired brain and nerve stimulationThis utilizes pairing of repetitive transcranial magnetic stimulation (rTMS) and peripheral nerve stimulation (rPNS) timed to converge in the cervical spinal cord. | Device | Paired brain and nerve stimulation |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 31889474Ling 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.
- Background: PubMed 29616203Gillick 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.
- Background: PubMed 36063483Pal 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.
- Background: PubMed 10686179Stefan 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.
- Background: PubMed 38758005McIntosh 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.
- Background: PubMed 41106070Murray 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.
- Background: PubMed 28053760Shulga 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Carmel, MD, PhD contact
Jason Carmel, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paired brain and nerve stimulation in people with Hemiplegic Cerebral Palsy, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaker Dukkipati, MD, PhD (2123046501, sd3850@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of muscle response to brain stimulation after intervention (percentage) (time frame: 30 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07607665, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.