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Baby Brain Recovery Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Sep 2026 → Jun 2027
See other at-risk trials from University of Wisconsin, Madison

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 2026 to Jun 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 3 of 18 entries
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Publications: details revised at 23 of 23 entries
    • Study description expanded, about 5 words
  2. 2 versions Re-verified since Sep 24, 2025, no change to tracked fieldsv19-v20
  3. Primary endpoints: 17 to 18
    • Eligibility criteria shortened, about 41 words
    • Publications: 22 to 23
    v18
  4. Primary endpoints: 14 to 17v17
  5. Study title shortened, about 2 wordsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Eligibility criteria expanded, about 5 wordsv15
  2. Start date changed from estimate of Aug 1, 2022 to Jul 26, 2022v14
  3. Start date: Jul 2022 to Aug 1, 2022v13
  4. Start date: Jun 2022 to Jul 2022v12
  5. Start date: May 2022 to Jun 2022v11
  6. Start date: Apr 2022 to May 2022v10
  7. Start date: Feb 2022 to Apr 2022
    • Enrollment target: 50 to 65
    v9
  8. Start date: Jan 2022 to Feb 2022v8
  9. Primary endpoints: 12 to 14v7 Show 4 more changesShow less
    • Start date: Dec 2021 to Jan 2022
    • Interventions: Behavioral Assessments (Behavioral), Magnetic Resonance Imaging (Device) to Behavioral Assessments (Behavioral), Magnetic Resonance Imaging (Device), Non invasive Transcranial Magnetic Stimulation (Device)
    • Study description expanded, about 36 words
    • Eligibility criteria expanded, about 2 words
  10. Start date: Nov 2021 to Dec 2021v6
  11. Trial status: Not Yet Recruiting to Recruitingv5 Show 6 more changesShow less
    • Primary endpoints: 6 to 12
    • Study sites: 0 to 1
    • Interventions: Magnetic Resonance Imaging (Device), Non invasive Transcranial Magnetic Stimulation (Device) to Behavioral Assessments (Behavioral), Magnetic Resonance Imaging (Device)
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study description expanded, about 114 words
  12. Start date: Oct 2021 to Nov 2021v4
  13. Start date: Sep 2021 to Oct 2021v3
  14. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05013736
Lead Sponsor University of Wisconsin, Madison
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Perinatal Stroke
Related terms Brain Injuries, Hypoxia-Ischemia, Brain
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov