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Baby Brain Recovery Study

ConditionPerinatal Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-24
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Other neurologic disorders unrelated to perinatal stroke/brain bleed/HIE

Metabolic disorders

Disorders of Cellular Migration and Proliferation

Acquired Traumatic Brain Injury

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Device

    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

    Behavioral

    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

    Device

    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.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Infants3 interventions

Trial outcomes

Primary outcomes

1

Change in Cortical excitability measured as presence/absence of motor evoked potentials (MEP)

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).

Time frame
3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
2

Change in Cortical excitability measured by intensity of motor threshold (MT)

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.

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

Change in Mean Fractional Anisotropy (FA) within the CST

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

Time frame
1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
4

Behavioral assessments: General Movements Assessment (GMA) reported on binary (Y/N) scale

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".

Time frame
1 ±1 month

Secondary outcomes

1

Change in blood pressure

Time frame
1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
2

Change in heart rate

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

Change in skin integrity reported as presence/absence of skin redness/rash

Time frame
1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
4

Change in body temperature

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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