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임상시험 NCT07220005 (LIFUS-OPTIMIZE)은(는) 뇌졸중, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments, 상지 약화에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization (LIFUS-OPTIMIZE) 24

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임상시험 NCT07220005 (LIFUS-OPTIMIZE)은(는) 뇌졸중, Arm Weakness as a Consequence of Stroke, Upper Extremity Hemiparesis, Upper Extremity Impairments, 상지 약화에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 12월 10일에 시작되어 24명의 참여자를 모집하고 있습니다. 듀크 대학교이(가) 진행하며, 2026년 6월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 12월 23일에 갱신되었습니다.
간단한 개요
The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions.

  • with increasing power, would LIFUS be more effective?
  • with the same power, what LIFUS timing is the best

For Aim 1, the study will co...

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공식 제목

Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

질환명
뇌졸중Arm Weakness as a Consequence of StrokeUpper Extremity HemiparesisUpper Extremity Impairments상지 약화
기타 연구 식별자
  • LIFUS-OPTIMIZE
  • Pro00117400
NCT 번호
NCT07220005
실제 연구 시작일
2025-12-10
최신 업데이트 게시
2025-12-23
예상 연구 완료일
2026-06-30
계획된 등록 인원
24
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Brain Stimulation
Transcranial Focused Ultrasound Stimulation
Low Intensity Focused Ultrasound Stimulation
Stroke Recovery
Motor Learning
Corticospinal Excitability
주요 목적
치료
설계 할당
비랜덤화 배정
중재 모델
교차 설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of 8 W/cm\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
실험적ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\^2
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
거짓 대조군Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\^2 or sham stimulation
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
실험적Pulse repetition frequency(PRF) at 2000 Hz
each participant will receive LIFUS with pulse repetition frequency at 2000 Hz
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
실험적Pulse repetition frequency(PRF) at 1000 Hz
each participant will receive LIFUS with pulse repetition frequency at 1000 Hz
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
실험적Pulse repetition frequency (PRF) at 500 Hz
Participants will receive LIFUS with pulse repetition frequency at 500 Hz
Low Intensity Focused Ultrasound Stimulation
A low-intensity focused ultrasound stimulation
주요결과변수
결과변수측정값 설명시간 범위
Motor sequence learning
Motor sequence learning (MSL) involves predictive processing that results in the anticipation of each component of a sequence of actions. MSL will produce response times and the MSL measure will be the number of responders (i.e., those with ≥20% reduction in the response time).
Baseline, immediately after intervention, and 1 hour after intervention
Corticospinal excitability
Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.
Baseline, immediately after intervention, and 1 hour after intervention.
참여 도우미
적격성 기준

연령대
성인, 노인
최소 연령
21 Years
참여 가능한 성별
전체
  • age >=21 years old of any gender or race
  • First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms
  • Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64
  • Inducible rest motor threshold and testing motor threshold recorded from the affected abductor pollicis brevis muscle

  • Bilateral strokes (infarcts and/or hematoma)
  • Other co-existent neuromuscular disorders affecting upper extremity motor impairment
  • History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study
  • History of confirmed dementia or taking dementia drugs
  • Uncontrolled hypertension despite medical treatment(s) at the time of enrollment, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and enrolled later)
  • Presence of any MRI/TMS/LIFUS risk factors
  • Concurrent enrollment in another interventional stroke recovery study
  • Concerns that the subject cannot comply with study procedures and visits
  • Pregnant
Duke University logo듀크 대학교
연구 대표 연락처
연락처: Clinical Research Coordinator, 919-668-7597, [email protected]
연락처: Ziping Huang, MS, [email protected]
1 1개국에 임상시험 장소

North Carolina

Duke University Hospital, Durham, North Carolina, 27710, United States
Megan Gonzalez, MS, 연락처, 919-668-7597, [email protected]
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