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Optimizing Cortical Priming

2026년 10월 2일 업데이트: Wan-Wen Liao

Optimizing Cortical Priming to Enhance Bimanual Arm Coordination in Individuals With Chronic Stroke

Each year over 795,000 people suffer from stroke resulting in the primary cause of adult disability. Persistent upper limb dysfunction due to stroke significantly impairs performance and results in a serious decline of quality of life. As most daily activities involve the use of both arms, restoring the coordination between upper limbs is essential for regaining functional independence. Only a few interventions have been designed for improving function of both arms, and most of these interventions have focused on movement retraining without directly facilitating the injured brain. The purpose of this study is to design and test a noninvasive brain stimulation protocol tailored to enhance the coordination between the arms in individuals with chronic stroke. The investigators propose that the dorsal premotor cortex on the noninjured side of the brain (cPMd) could serve as a potential stimulation target for enhancing arm coordination and brain function. In the first part of this study (Aim 1), the investigators will examine its effects on modulating arm movements in individuals with chronic stroke. In the second part of this study (Aim 2), the investigators will upregulate the activity of the most responsive region (cPMd or iM1) of each participant prior to arm movement training (bilateral arm training, BAT) to determine the combined effects on augmenting bilateral arm coordination and brain function in individuals with chronic stroke.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

14

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Baltimore, Maryland, 미국
        • Physical Therapy & Rehabilitation Science, University of Maryland Baltimore

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

Stroke Participants:

  • Age 50 years and older
  • Unilateral ischemic cortical or white matter subcortical stroke
  • At least 6 months post-stroke and have completed all inpatient and outpatient therapy
  • Residual arm paresis as indicated by Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scores between 25 and 65 (individuals in this range have demonstrated the ability to generate motor evoked potentials during active muscle contraction)
  • Able to reach forward for at least 15 centimeters

Healthy Controls:

  • Age-matched to a stroke participant within plus or minus 3 years
  • Gender-matched to a stroke participant

Exclusion Criteria:

Stroke Participants and Healthy Controls:

  • A non-stroke neuromuscular disorder restricting exercise
  • Stroke involving the brainstem or cerebellum
  • Any medical conditions that could limit physical activity levels required for testing and training, such as acute cardiac or pulmonary/respiratory conditions, or uncontrolled hypertension (blood pressure greater than 180/100 mmHg)
  • Significant orthopedic or chronic pain conditions limiting upper extremity movements
  • Any medications that may adversely impact upper extremity control
  • Metallic implant in the head or chest, implanted pumps/stimulators/shunts, or cardiac pacemaker
  • A history of seizures
  • Use of any neuropsychoactive medication
  • History of fainting spells of undetermined etiology
  • Pregnancy
  • Any other concomitant neurological condition affecting sensorimotor systems, such as brain tumor, substance abuse, or dementia

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Contralesional Dorsal Premotor Cortex

Participants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the contralesional dorsal premotor cortex (cPMd) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of 5 Hz cPMd rTMS only. In Aim 2, participants who were responsive to cPMd stimulation received 5 Hz cPMd rTMS immediately prior to bilateral arm training (BAT) for 3 sessions.

Participant received 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) only (Aim 1) and 5 Hz repetitive transcranial magnetic stimulation (rTMS) on the contralesional dorsal premotor cortex (cPMd) combined with 3 essions of bilateral arm training (Aim 2)

실험적: 5 Hz Repetitive Transcranial Magnetic Stimulation (rTMS) over Ipsilesional Primary Motor Cortex

Participants received high-frequency (5 Hz) repetitive Transcranial Magnetic Stimulation (rTMS) delivered over the ipsilesional primary motor cortex (iM1) using a figure-of-eight magnetic coil. In Aim 1, participants received a single session of iM1 rTMS only. In Aim 2, participants who were responsive to iM1 stimulation received iM1 rTMS immediately prior to bilateral arm training (BAT) for 3 sessions.

Participant received 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) only (Aim 1) and 5 Hz rTMS on the ipsilesional primary motor cortex (iM1) combined with 3 essions of bilateral arm training (Aim 2)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cortical Excitability Assessed by Transcranial Magnetic Stimulation (TMS)-Induced Motor Evoked Potential (MEP) Amplitude
기간: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

Cortical excitability was quantified using single-pulse Transcranial Magnetic Stimulation (TMS) over the targeted motor cortex. Peak-to-peak amplitude of Motor Evoked Potentials (MEPs) recorded from the target upper limb muscle via surface electromyography (EMG) was measured in microvolts to evaluate stimulation- and training-induced neuroplastic changes.

Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
Interlimb Coordination Assessed by Surface Electromyography (EMG) -Interlimb Muscle Coherence
기간: Day 1: Baseline and within 30 minutes post-stimulation (Aim 1)

Interlimb coordination was quantified by measuring interlimb muscle coherence (intermuscular coherence) between homologous upper limb muscles via surface electromyography (EMG) during bilateral arm movements. Coherence was calculated in the frequency domain, where higher values indicated greater synchronous neural drive and coordination between the two upper limbs.

Day 1: Baseline and within 30 minutes post-stimulation (Aim 1)
Arm Reaching Kinematics (Speed, Acceleration, Interlimb Coordination, and Trajectory Smoothness) Assessed by the 3D Kinesiological Instrument for Normal and Altered Reaching Movement (KINARM)
기간: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training) (Aim 2)

Upper limb kinematic performance during arm reaching tasks was assessed using the 3D Kinesiological Instrument (KINARM). Specific kinematic parameters analyzed included: (1) movement speed, (2) movement acceleration, (3) interlimb coordination, and (4) arm trajectory smoothness.

Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training) (Aim 2)

2차 결과 측정

결과 측정
측정값 설명
기간
Intracortical Inhibition Assessed by Paired-Pulse Transcranial Magnetic Stimulation (TMS)- Short-Interval Intracortical Inhibition (SICI)
기간: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

Intracortical inhibition was quantified using paired-pulse Transcranial Magnetic Stimulation (TMS) over the motor cortex, recorded via surface electromyography (EMG) from the target upper limb muscle. A subthreshold conditioning stimulus followed by a suprathreshold test stimulus was applied. Intracortical inhibition was expressed as the ratio or percentage of the conditioned Motor Evoked Potential (MEP) amplitude relative to the unconditioned test MEP amplitude (% of test MEP), where lower percentages indicated greater intracortical inhibition.

Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
Interhemispheric Inhibition Assessed by Transcranial Magnetic Stimulation (TMS) Ipsilateral Silent Period (iSP)
기간: Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)

Interhemispheric inhibition was quantified by the Ipsilateral Silent Period (iSP), elicited by delivering single-pulse Transcranial Magnetic Stimulation (TMS) to the motor cortex ipsilateral to the target upper limb during voluntary isometric muscle contraction. The iSP was recorded via surface electromyography (EMG) and quantified by duration in milliseconds (ms) and normalized area of EMG suppression (%).

Aim 1: Day 1 (Baseline and within 30 minutes post-stimulation); Aim 2: Day 1 (Baseline) and Day 3 (within 30 minutes after completing 3 sessions of bilateral arm training)
Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE)
기간: Aim 1: Day 1 (Baseline); Aim 2: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training)

The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a performance-based impairment index used to assess upper limb motor recovery in individuals with post-stroke hemiparesis. The upper extremity motor domain consists of 33 items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Each item is scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), yielding a total motor score ranging from 0 to 66, where higher scores indicate better upper extremity motor function (less motor impairment).

Aim 1: Day 1 (Baseline); Aim 2: Day 1 (Baseline) and Day 3 (within 60 minutes after completing 3 sessions of bilateral arm training)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 4월 1일

기본 완료 (실제)

2018년 5월 1일

연구 완료 (실제)

2018년 5월 1일

연구 등록 날짜

최초 제출

2026년 2월 4일

QC 기준을 충족하는 최초 제출

2026년 10월 2일

처음 게시됨 (실제)

2026년 10월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • HP00068268

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

To protect the privacy of stroke participants and adhere to the Institutional Review Board (IRB) guidelines, individual participant data (IPD) will not be made publicly available. The raw neurophysiological data and clinical assessments are reserved for the research team to complete the primary and secondary analyses specified in the study protocol. However, de-identified aggregate results and study documents will be shared through peer-reviewed publications. Some participant data were shared on one of our publications (https://doi.org/10.1016/j.clinph.2019.04.711)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

아니

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. .