Spinal Cord Associative Plasticity in Cerebral Palsy (SCAP-CP)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jason Carmel, MD, PhD
- E-post: jbc28@cumc.columbia.edu
Studera Kontakt Backup
- Namn: Shaker Dukkipati, MD, PhD
- Telefonnummer: 2123046501
- E-post: sd3850@cumc.columbia.edu
Studieorter
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New York
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New York, New York, Förenta staterna, 10040
- Rekrytering
- Columbia University Irving Medical Center
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Kontakt:
- Jason Carmel, MD, PhD
- E-post: jbc28@cumc.columbia.edu
-
Kontakt:
- Shaker Dukkipati, MD, PhD
- Telefonnummer: 2123046501
- E-post: sd3850@cumc.columbia.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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This utilizes pairing of repetitive transcranial magnetic stimulation (rTMS) and peripheral nerve stimulation (rPNS) timed to converge in the cervical spinal cord.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Size of muscle response to brain stimulation after intervention (percentage)
Tidsram: 30 minutes after intervention
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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.
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30 minutes after intervention
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Number of blocks moved during box and blocks testing (BBT) after intervention
Tidsram: 30 minutes after intervention
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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.
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30 minutes after intervention
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jason Carmel, MD, PhD, Columbia University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAAV2760-CP
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