Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke
연구 개요
상세 설명
The goal of this study is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in stroke patients. This study has a crossover design comparing low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude modulation in kTMP on upper extremity kinematics in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.
The trial also aims to assess the short-term effects of kTMP on reach-to-grasp kinematics. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate short term changes in motor performance.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Berkeley, California, 미국, 94704
- Magnetic Tides Inc.
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18-80 years who have a history of a unilateral stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-55.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion Criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S ≥ 6/12 (with proprioception ≥ 2/4).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study assessments/testing through the last visit.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 3).
- Absolute contraindications related to non-invasive brain stimulation, including:
History of seizures in the last 12 months while taking anti-epilepsy medication Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants Permanent eye liner or head tattoos Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Stimulation Condition A
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
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새로운 비침습적 뇌 자극 도구
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실험적: Stimulation Condition B
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
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새로운 비침습적 뇌 자극 도구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Reach-to-grasp (Range of Motion)
기간: 3 weeks
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Defined as the standard deviation of the joint angle time series for a given trial.
The average will be computed over a set of 15 trials.
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3 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Fugl- Meyer Assessment (Upper Extremity)
기간: 3 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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3 weeks
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Modified Ashworth Scale (MAS)
기간: 3-weeks
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Clinical tool for measuring muscle spasticity and increased muscle tone.
The MAS is a 6-point scale (0, 1, 1+, 2, 3, 4) measuring spasticity from no increase in tone to rigid limbs.
Higher scores indicate greater spasticity, increased muscle tone, and greater upper limb rigidity, reflecting poorer outcomes.
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3-weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
키워드
기타 연구 ID 번호
- Magnetic Tides Inc
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. .
뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병
kTMP에 대한 임상 시험
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Magnetic TidesNational Institute of Neurological Disorders and Stroke (NINDS); University of California...모병뇌졸중 | 뇌졸중의 결과로서의 팔 약화 | 만성 뇌졸중 환자미국
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University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS)아직 모집하지 않음
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Magnetic TidesUniversity of California, Berkeley완전한