- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607665
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jason Carmel, MD, PhD
- 이메일: jbc28@cumc.columbia.edu
연구 연락처 백업
- 이름: Shaker Dukkipati, MD, PhD
- 전화번호: 2123046501
- 이메일: sd3850@cumc.columbia.edu
연구 장소
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New York
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New York, New York, 미국, 10040
- 모병
- Columbia University Irving Medical Center
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연락하다:
- Jason Carmel, MD, PhD
- 이메일: jbc28@cumc.columbia.edu
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연락하다:
- Shaker Dukkipati, MD, PhD
- 전화번호: 2123046501
- 이메일: sd3850@cumc.columbia.edu
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Size of muscle response to brain stimulation after intervention (percentage)
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jason Carmel, MD, PhD, Columbia University
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AAAV2760-CP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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