Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT05013736

Conditions

Perinatal Stroke

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging

Behavioral Assessments

Non invasive Transcranial Magnetic Stimulation

Study Details

Brief summary:

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.

Conditions

Perinatal Stroke

Study ID

NCT05013736

Start date

Jul 26, 2022

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

65 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Magnetic Resonance Imaging

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.

Behavioral Assessments

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.

Non invasive Transcranial Magnetic Stimulation

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.

Primary outcome measure

  • Change in Cortical excitability measured as presence/absence of motor evoked potentials (MEP) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 ±1 month ]
  • Behavioral assessments: General Movements Assessment (GMA) reported on binary (Y/N) scale [ Time Frame: 3 ±1 months ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score [ Time Frame: 1 ±1 month ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score [ Time Frame: 3-6 months (one visit in this time frame) ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score [ Time Frame: 12±1 months ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score [ Time Frame: 18±1 months ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) global score [ Time Frame: 24±1 months ]
  • Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) Asymmetry Scores [ Time Frame: 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 [ Time Frame: 3-6 months (one visit in this time frame) ]
  • Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-4) score [ Time Frame: 12±1 months ]
  • Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-IV) score [ Time Frame: 18±1 months ]
  • Behavioral assessments: Bayley Scales of Infant and Toddler Development Test, 4th edition (Bayley-4) score [ Time Frame: 24±1 months ]
  • Baby Observation of Selective Control AppRaisal (Baby OSCAR) [ Time Frame: 1±1 month ]
  • Baby Observation of Selective Control AppRaisal (Baby OSCAR) [ Time Frame: 3-6 months (one visit in this time frame) ]
  • Change in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) [ Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months ]

Central Contacts and Locations

Central contacts

Bernadette Gillick, PhD, MSPT

608-262-3079bgillick@wisc.edu

Locations

University of Wisconsin School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jan 8, 2026

Last verified

Sep, 2025

Keywords

  • Magnetic Resonance Imaging (MRI)
  • Brain Reorganization
  • Brain Lesions
  • perinatal stroke
  • neonatal hemorrhagic stroke
  • neonatal thrombotic stroke
  • neonatal intracranial hemorrhage
  • neonatal periventricular leukomalacia
  • hypoxic ischemic encephalopathy
  • neonatal brain bleed
  • early brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-01-08.