- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04807764
SCI를 위한 경척수 자극 플러스 운동 훈련
고주파 척수 경추 자극을 통한 프라이밍으로 척수 손상 시 운동 효과 향상
연구 개요
상태
상세 설명
척수 손상(SCI)은 서고 걷는 능력을 크게 손상시켜 일상 생활 활동을 심각하게 손상시킵니다. 이러한 결손은 운동 훈련으로 부분적으로 개선되지만, 여러 번의 훈련 세션 후에도 비정상적인 근육 활동과 협응은 여전히 지속됩니다. 따라서 운동 훈련만으로는 뇌, 척수 및 국소 회로를 연결하는 시냅스를 강화하는 데 필요한 신경 가소성을 완전히 최적화할 수 없습니다. 따라서 척추 운동 네트워크의 신경 조절을 효과적으로 촉진하고 신체 재활과 함께 손상된 인간 척수의 신경 연결성을 강화하는 치료 중재가 절실히 필요합니다. 운동 훈련에 더 잘 반응하도록 신경계를 상승적으로 '프라이밍'하는 방법으로 경피적 척수(경척수) 자극이 제안되었습니다. 경척수 자극은 내림차순 및 국소 입력 기능을 위한 전제 조건인 여러 척수 분절에 대한 운동신경 흥분성을 변경합니다. 중요한 것은 경척추 자극 및 운동 훈련을 통한 동시 치료가 SCI 후 운동 회복을 최대화하는지 여부는 알려지지 않았습니다. 이 임상 시험의 목표는 고주파(30Hz) 경척추 자극을 사용하여 운동 훈련을 촉진하고 궁극적으로 만성 불완전 SCI(iSCI)가 있는 개인의 서기, 걷기 및 전반적인 기능을 개선하는 것입니다. iSCI를 가진 45명의 개인은 고주파 경척추 자극으로 준비된 체중 지원 단계 훈련의 40개 세션을 받게 됩니다. 참가자는 서 있는 동안(진짜 또는 가짜) 또는 누운 동안(진짜) 경척수 자극을 받도록 무작위 배정됩니다. 목표 1은 다리에서 기록된 모터 유발 전위에 의해 표시된 대로 SCI에서 고주파 경척추 자극으로 프라이밍 운동 훈련이 피질 운동 신경 연결 강도를 변경하는 방법을 평가합니다.
목표 2는 iSCI에서 고주파수 경척추 자극으로 프라이밍 운동 훈련이 척추 신경 회로의 재구성 및 적절한 참여에 어떻게 영향을 미치는지 평가합니다. 마지막으로 목표 3은 활동 기반 운동 기능, 서고 걷는 능력, 삶의 질을 평가합니다. 이러한 결과는 긴장성 고주파 경척추 자극이 피질 운동 신경 연결을 강화하고 자세 의존 피질 척수 신경 가소성을 통해 척추 회로 조직을 개선한다는 개념을 뒷받침합니다. 이 기계론적 임상 시험에서 얻은 정보는 임상 실습에 큰 영향을 미칠 것으로 예상됩니다. 이는 실제 임상 환경에서 비침습적 경척추 자극이 침습적 경막외 자극보다 더 쉽고 광범위하게 시행될 수 있기 때문입니다.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Maria Knikou, PT, PhD
- 전화번호: 17189823316
- 이메일: Maria.Knikou@csi.cuny.edu
연구 연락처 백업
- 이름: Noam Y. Harel, MD, PhD
- 전화번호: 1742 718-584-9000
- 이메일: noam.harel@mountsinai.org
연구 장소
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New York
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Bronx, New York, 미국, 10468
- 모병
- Veterans Affairs Medical Center
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연락하다:
- Noam Y. Harel, MD, PhD
- 전화번호: 1742 718-584-9000
- 이메일: noam.harel@mountsinai.org
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연락하다:
- Gregory Mendez, BS
- 전화번호: 3107 718-584-9000
- 이메일: gregory.mendez1@va.gov
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Staten Island, New York, 미국, 10314
- 모병
- Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
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연락하다:
- Maria Knikou, PT, PhD
- 전화번호: 718-982-3316
- 이메일: maria.knikou@csi.cuny.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 연구 기간 동안 모든 연구 절차 및 가용성을 준수하려는 의지.
- 동의서를 이해하고 동의서에 서명할 수 있는 능력.
- 18-70세의 남성 또는 여성.
- 병력에 의해 입증된 바와 같이 일반적으로 건강 상태가 양호합니다.
- 모터 불완전 SCI(AIS C-D)로 진단되었습니다.
- 고관절(근위 대퇴골)의 골밀도 T-점수
- 하부 운동 신경 병변이 없는지 확인하기 위해 흉부(T) 10 위의 병변.
- 가자미근 H-반사를 유발할 수 있는 힘줄 반사의 존재.
- 피질 척수 및 척추 흥분성은 발목 각도를 기반으로 하기 때문에 수동적 또는 능동적 발목 움직임을 방지하는 영구 발목 관절 구축이 없습니다. Lokomat의 발목 스트랩에는 유연한 발목 관절도 필요합니다.
- 외상, 혈관 또는 정형외과적 병리학으로 인한 최초 SCI 진단.
- 6개월 이상의 SCI 후 시간.
- 심폐질환이나 인지장애가 없는 안정적인 의학적 상태.
제외 기준:
- 척추상 병변.
- 말초 신경계의 중요한 신경병증.
- 척추 또는 척수의 중대한 퇴행성 신경학적 장애.
- AIS A 또는 B.
- 욕창의 존재.
- 고급 요로 감염.
- 척추 또는 척수의 종양 또는 혈관 장애.
- 진행 중인 연구 또는 새로운 재활 프로그램에 참여.
- 임산부 또는 임신했거나 임신할 가능성이 있는 여성은 태아에 대한 흉요추 자극의 위험이 알려지지 않았기 때문에 참여에서 제외됩니다.
- 달팽이관 이식, 심박조율기, 이식된 주입 장치 및/또는 모든 유형 및 목적의 이식된 자극기를 가진 사람은 자극으로 인한 오작동을 피하기 위해 제외됩니다.
- 발작 병력이 있는 사람.
- 발작 가능성을 높이는 의학적 상태.
- 발작 역치를 변경할 수 있는 약물.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 서 있는 동안 전달된 실제 경척추 자극과 운동 훈련
안전을 보장하기 위해 기립 프레임 또는 Lokomat에서 필요에 따라 체중 지지대(BWS)를 사용하여 서 있는 동안 흉요추 영역의 경척수 긴장 자극이 30Hz의 주파수로 전달됩니다.
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척수 손상이 있는 15명의 사람들은 서 있는 동안 30분간의 비침습적 고주파(예: 30Hz) 경피 경척추 자극과 30분간 보조 보행 로봇 보행 훈련을 매일 40회씩 받게 됩니다.
훈련 전후에 표준화된 임상 및 신경생리학적 검사를 사용하여 감각 운동 기능의 회복을 평가합니다.
다른 이름들:
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실험적: 반듯이 누운 상태에서 전달되는 실제 경척추 자극 후 운동 훈련
반듯이 누운 상태에서 경척수 긴장 자극이 30Hz의 주파수로 전달됩니다.
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척수 손상이 있는 15명의 사람들은 치료 테이블에 반듯이 누운 상태에서 30분 동안 비침습적 고주파(예: 30Hz) 경피 경척추 자극을 매일 40회 받은 후 30분 동안 보행 보조 로봇 보행 훈련을 받게 됩니다.
훈련 전후에 표준화된 임상 및 신경생리학적 검사를 사용하여 감각 운동 기능의 회복을 평가합니다.
다른 이름들:
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가짜 비교기: 서 있는 동안 전달된 가짜 경척추 자극과 운동 훈련
한 가짜 그룹은 감각이 없는 강도로 서 있는 동안 경척추 자극을 받게 됩니다.
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척수 손상이 있는 15명의 사람들은 감각이 없는 강도로 서 있는 동안 30분 동안 가짜 경척추 자극을 받은 후 30분 동안 로봇 보행 훈련을 받는 매일 40회 세션을 받게 됩니다.
훈련 전후에 표준화된 임상 및 신경생리학적 검사를 사용하여 감각 운동 기능의 회복을 평가합니다.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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척추 신경 네트워크의 가소성
기간: 4 년
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신경생리학적 평가는 휴식 시와 로봇 보조 스테핑 중 후경골 및 일반비골신경 자극 후 가자미근 H-반사의 진폭 변조를 기록하여 개입으로 인한 흥분성 및 억제성 척추 반사 흥분성의 변화를 조사합니다.
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4 년
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피질 척수 네트워크의 가소성
기간: 4 년
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휴식 시 및 로봇 보조 스테핑 동안 단일 펄스 경두개 자기 자극(TMS)에 대한 반응을 기록하여 개입으로 인한 피질척수 흥분성의 변화를 평가하는 신경생리학적 측정.
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4 년
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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보행 기능
기간: 4 년
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2분 걷기와 10미터 시간 테스트의 변화.
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4 년
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균형
기간: 4 년
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BESTtest 임상 평가의 변화.
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4 년
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자율 기능
기간: 4 년
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참가자가 장, 방광 및 성기능의 변화를 인지했는지 평가하는 설문지
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4 년
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공동 작업자 및 조사자
수사관
- 수석 연구원: Noam Y. Harel, MD, PhD, Bronx Veterans Medical Research Foundation
- 수석 연구원: Maria Knikou, PT, PhD, Research Foundation of the City University of New York
간행물 및 유용한 링크
일반 간행물
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