이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

주산기 뇌졸중: 유아기 동안의 뇌 재구성

2026년 9월 15일 업데이트: University of Wisconsin, Madison

주산기 뇌졸중: 신경흥분성, 신경영상 및 운동 발달을 통한 유아 뇌 조직 및 회복의 종단 평가

This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with perinatal stroke.

65 participants will be recruited and complete 1 visit at time point 1 (0-2 months), and 2 visits at each timepoints 2-5 with windows of +- 4 weeks (3-6 months, 12 months, 18 months and 24 months). Visits will consist of Magnetic Resonance Imaging (MRI) assessment during the child's natural sleep, Transcranial Magnetic Stimulation (TMS), and Motor Behavioral Assessments.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Perinatal stroke has disabling consequences; 50-75% of individuals will develop life-long motor impairment, and 10-60% will also have cognitive deficits. These deficits lead to challenges in the school and home environments, with decreased likelihood of employment and independence and increased caregiver burden. Additionally, perinatal stroke is one of the primary causes of cerebral palsy (CP), a chronic and disabling neurological condition affecting motor function.

The first two years of life constitute a critical period of brain development and heightened neuroplasticity. There is now a consensus that, due to brain plasticity and rapid development, providing an early intervention may result in optimal recovery and lower costs of care. Unfortunately, researchers still have only limited understanding of how the brain develops after perinatal stroke and as a result CP diagnoses are typically not made until two years of age. There is an urgent need for very early diagnosis, prognosis and understanding of mechanisms in order to develop novel early interventions to improve outcomes in perinatal stroke with resultant CP.

Integrating study team's experience in studying and caring for this vulnerable infant stroke population, they propose to use non-invasive brain stimulation, neuroimaging, and behavioral assessments to analyze associations between development patterns, especially in the CST, and potential diagnosis of CP.

Specific aims of this study are:

  • Aim 1. Map the presence and excitability of corticospinal pathways.
  • Aim 2. Map the structural integrity and connectivity of corticospinal pathways.
  • Aim 3. Compare motor outcomes from clinical behavioral assessments against corticospinal tract excitability and integrity.
  • Aim 4. Identify the association between brain white-matter connectivity and general movements.
  • Aim 5. Identify the association between corticospinal circuitry and general movements.

Protocol Amendment approved on 10/22/2021 removes TMS intervention and outcomes, adds a study time point at 0-2 months, and lowers the eligibility age to term.

Protocol Amendment approved on 12/21/2021 adds the TMS intervention back.

연구 유형

관찰

등록 (추정된)

65

연락처 및 위치

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

연구 연락처

  • 이름: Bernadette Gillick, PhD, MSPT
  • 전화번호: 608-262-3079
  • 이메일: bgillick@wisc.edu

연구 장소

    • Wisconsin
      • Madison, Wisconsin, 미국, 53705
        • 모병
        • University of Wisconsin School of Medicine and Public Health

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

1초 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Pre-term and term born infants with corrected gestational age between term age and 24 months with radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, or periventricular leukomalacia. Parents/legal guardians and infants able to attend study visits at the University of Wisconsin-Madison.

설명

Main Inclusion Criteria:

  • Infants with corrected gestational age between term age and 24 months of age at study enrollment
  • Radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, periventricular leukomalacia, and hypoxic-ischemic encephalopathy (HIE)
  • English-speaking parent/legal guardian (able to provide consent)

Main Exclusion Criteria:

  • Other neurologic disorders unrelated to perinatal stroke/brain bleed/HIE
  • Metabolic disorders
  • Disorders of Cellular Migration and Proliferation
  • Acquired Traumatic Brain Injury

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
Infants

Pre-term and term born infants with corrected gestational age between term age and 24 months with radiologically-confirmed acute unilateral or bilateral brain lesions, including perinatal stroke, neonatal hemorrhagic or thrombotic stroke, involving the motor cortex and/or subcortical structures, and intracranial hemorrhage, involving the motor cortex and/or subcortical white matter, or periventricular leukomalacia. Parents/legal guardians able to attend study visits at the University of Wisconsin-Madison.

3 Tesla Discovery MR750 MRI scanner (GE Healthcare, Waukesha, WI) will be used to perform structural imaging, diffusion MRI, relaxometry and microstructural imaging. The exact scan length and parameters of each scan type (T1, T2, DWI) will be set for this study to optimize the quality of data and decrease the length of scanning session for each type of scan. All of the imaging methods have been previously implemented at UW-Madison. Each sequence will take approximately 5-10 minutes.

다른 이름들:
  • MRI

The behavioral assessments (GMA: General Movements Assessment; HINE: Hammersmith Infant Neurological Examination; Baby Observation of Selective Control AppRaisal (BabyOSCAR); Bayley-4 / Bayley Scales of Infant and Toddler Development 4th ed; Pediatric Evaluation of Disability Inventory -Computer Adaptive Test (PEDI-CAT)) are infant and age-specific and will be administered by trained pediatric occupational and physical therapists.

TMS will be used to assess cortical excitability and circuitry (not as a neuromodulation intervention). Single-pulse TMS (Magstim 200², Magstim, UK) with a scalp surface coil will be used to assess how the brain is developing and how connected the tract is, between the brain and a target muscle on the arm. 10-20 TMS stimulation pulses will be delivered at a range of stimulation intensities (50-100%) increasing by 5% maximal stimulator output (MSO) at each stage. After this assessment, a brief assessment of peripheral nerve excitability will be performed. Peripheral stimulation will begin at 40% MSO. Stimulation intensity will be adjusted in increments of 5% until motor responses are evident on the EMG. Once motor responses are identified, 10 pulses will be delivered at the stimulation intensity that produced the response. In sum, around 150 stimulation pulses per hemisphere of brain stimulation and 22-60 pulses of peripheral stimulation are expected for TMS assessment of each infant.

다른 이름들:
  • TMS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Cortical excitability measured as presence/absence of motor evoked potentials (MEP)
기간: 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

Motor evoked potentials (MEPs) are the electrical signals recorded from the descending motor pathways or from muscles following stimulation of motor pathways within the brain.

Responses from TMS pulses will be measured by recording muscle activity, referred to as motor evoked potentials (MEP).

3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
Change in Cortical excitability measured by intensity of motor threshold (MT)
기간: 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

The MT is the minimum stimulation intensity that will elicit a consistent MEP of a pre-determined amplitude. MT and MEP are the common measures of TMS-induced excitability. Together, these measures provide information about the brain's excitability, associated with synaptic activity.

3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
Change in Mean Fractional Anisotropy (FA) within the CST
기간: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

Mean Fractional Anisotropy (FA) within the CST will be used to study structural connectivity. It is a dimensionless index between 0 and 1. (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1).

N=10 infants aged 0-2 months (first timepoint) will participate in MRI scans

1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
Behavioral assessments: General Movements Assessment (GMA) reported on binary (Y/N) scale
기간: 1 ±1 month

The General Movements Assessment is used to identify absent or abnormal general movements. GMA requires 5-10 minutes video taping when infants are placed in spine position for scoring.

"Absence or abnormal movements" will be reported as "Y".

1 ±1 month
Behavioral assessments: General Movements Assessment (GMA) reported on binary (Y/N) scale
기간: 3 ±1 months

The General Movements Assessment is used to identify absent or abnormal general movements. GMA requires 5-10 minutes video taping when infants are placed in spine position for scoring.

"Absence or abnormal movements" will be reported as "Y".

3 ±1 months
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score
기간: 1 ±1 month

The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. High-risk cutoff scores for cerebral palsy are <57 at 3 months and <73 at 6, 9, or 12 months. See Novak et al, 2017 linked in the reference section for context.

1 ±1 month
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score
기간: 3-6 months (one visit in this time frame)

The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. High-risk cutoff scores for cerebral palsy are <57 at 3 months and <73 at 6, 9, or 12 months. See Novak et al, 2017 linked in the reference section for context.

3-6 months (one visit in this time frame)
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score
기간: 12±1 months

The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. High-risk cutoff scores for cerebral palsy are <57 at 3 months and <73 at 6, 9, or 12 months. See Novak et al, 2017 linked in the reference section for context.

12±1 months
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score
기간: 18±1 months

The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. High-risk cutoff scores for cerebral palsy are <57 at 3 months and <73 at 6, 9, or 12 months. See Novak et al, 2017 linked in the reference section for context.

18±1 months
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score
기간: 24±1 months

The HINE includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour. The first section evaluates cranial nerve, posture, movements, tone and reflexes. These items are not age-dependent. The second section evaluates head control, sitting, voluntary grasping, rolling, crawling and walking. The third section evaluates state of consciousness, emotional state and social orientation.

The maximum score for any one item is a score of 3 and the minimum is a score of 0. A subscore can be given for each section and the overall global score can be calculated by summing up all 26 items (range: 0-78), with higher scores indicating better neurological performance. High-risk cutoff scores for cerebral palsy are <57 at 3 months and <73 at 6, 9, or 12 months. See Novak et al, 2017 linked in the reference section for context.

24±1 months
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) Asymmetry Scores
기간: data collected at 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

An asymmetry can also be recorded for each item, with one point maximum allotted per item, with a total score ranging from 0-26. Based on the literature regarding asymmetries, the cutoff score of >3 asymmetries will be used for recommendation of referral to early intervention service. See article by Fehlings, 2024 for additional context.

data collected at 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-4) score
기간: 3-6 months (one visit in this time frame)

Bayley-4 is a developmental test that measures cognitive, language, motor, and social-emotional domains of infants and young children between 1 and 42 months of age. A higher score generally corresponds with higher function.

3-6 months (one visit in this time frame)
Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-4) score
기간: 12±1 months

Bayley-4 is a developmental test that measures cognitive, language, motor, and social-emotional domains of infants and young children between 1 and 42 months of age. A higher score generally corresponds with higher function.

12±1 months
Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-IV) score
기간: 18±1 months

Bayley-4 is a developmental test that measures cognitive, language, motor, and social-emotional domains of infants and young children between 1 and 42 months of age. A higher score generally corresponds with higher function.

18±1 months
Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-4) score
기간: 24±1 months

Bayley-4 is a developmental test that measures cognitive, language, motor, and social-emotional domains of infants and young children between 1 and 42 months of age. A higher score generally corresponds with higher function.

24±1 months
Baby Observation of Selective Control AppRaisal (Baby OSCAR)
기간: 1±1 month

Baby OSCAR assessments are scored from video recordings of infant movement. Each limb is scored separately, with scores ranging 0-7 per lower limb, and 0-9 per upper limb for a total score of 0-32. Higher scores indicate better selective motor control.

1±1 month
Baby Observation of Selective Control AppRaisal (Baby OSCAR)
기간: 3-6 months (one visit in this time frame)

Baby OSCAR assessments are scored from video recordings of infant movement. Each limb is scored separately, with scores ranging 0-7 per lower limb, and 0-9 per upper limb for a total score of 0-32. Higher scores indicate better selective motor control.

3-6 months (one visit in this time frame)
Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT)
기간: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

Patient/caregiver-reported outcome measure of functional abilities and performance in children with disabilities. Scores are displayed instantly after completion of an assessment. A Detailed Score Report and a Summary Score Report are available. Normative scores are provided as age percentiles and T scores are based on a child's chronological age and intended for use by clinicians so that they may interpret a particular child's functioning relative to others of the same age. Scaled scores provide a way to look at a child's current functional skills and progress in these skills over time. Scaled scores are especially helpful in documenting improvements in functional skills for children not expected to exhibit or regain normative levels of functioning.

1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

2차 결과 측정

결과 측정
측정값 설명
기간
혈압의 변화
기간: 1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
심박수의 변화
기간: 1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
피부 발적/발진의 유무로 보고된 피부 무결성의 변화
기간: 1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
체온의 변화
기간: 1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
1 ±1개월, 3-6개월(이 기간 동안 1회 방문), 12±1개월, 18±1개월, 24±1개월
Change in respiration rate
기간: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

Respiration rate will be measured as breaths/minute.

1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Bernadette Gillick, PhD, MSPT, University of Wisconsin, Madison

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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)

2022년 7월 26일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2021년 8월 13일

QC 기준을 충족하는 최초 제출

2021년 8월 13일

처음 게시됨 (실제)

2021년 8월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 15일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2021-0412
  • SMPH/PEDIATRICS/PEDIATRICS (기타 식별자: UW Madison)
  • A536761 (기타 식별자: UW Madison)
  • 7R01HD098202-02 (미국 NIH 보조금/계약)
  • Protocol ver 15 (기타 식별자: UW Madison)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data collected during the trial will be shared after deidentification.

IPD 공유 기간

Beginning 3 months after publication of primary outcomes, and ending 5 years after that date

IPD 공유 액세스 기준

Data will be shared with the researchers whose proposed use of the data is for independent verification of study outcomes or to conduct subsequent clinical research. Data sharing will be approved by an independent review committee identified for this purpose.

Proposals should be directed to bgillick@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

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. .