Baby Brain Recovery Study

RecruitingOBSERVATIONAL
Enrollment

65

Participants

Timeline

Start Date

July 26, 2022

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Perinatal Stroke
Interventions
DEVICE

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

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.

DEVICE

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. In sum, around 150 stimulation pulses per hemisphere are expected for TMS assessment for each infant.

Trial Locations (1)

53705

RECRUITING

University of Wisconsin School of Medicine and Public Health, Madison

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of Wisconsin, Madison

OTHER