Baby Brain Recovery Study

NCT05013736 | Recruiting DMC FDA Device

• 5 other identifiers: 2021-0412A536761SMPH/PEDIATRICS/PEDIATRICSProtocol ver 157R01HD098202-02
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (18)

• 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).

  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)

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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)

  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)

  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)

  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

Secondary Outcomes (5)

• Change in blood pressure

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

• Change in heart rate

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

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

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

• Change in body temperature

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

• Change in respiration rate

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

Study Arms (1)

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.

Device: Magnetic Resonance Imaging; Behavioral: Behavioral Assessments; Device: Non invasive Transcranial Magnetic Stimulation

Interventions

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.

Also known as: MRI

Infants

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.

Infants

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.

Also known as: TMS

Infants

Eligibility Criteria

• Age: 0 Years - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

RECRUITING

Related Publications (23)

• Ganesan V, Hogan A, Shack N, Gordon A, Isaacs E, Kirkham FJ. Outcome after ischaemic stroke in childhood. Dev Med Child Neurol. 2000 Jul;42(7):455-61. doi: 10.1017/s0012162200000852.

  PMID: 10972417 BACKGROUND

• Kirton A, Deveber G. Life after perinatal stroke. Stroke. 2013 Nov;44(11):3265-71. doi: 10.1161/STROKEAHA.113.000739. Epub 2013 Oct 8. No abstract available.

  PMID: 24105698 BACKGROUND

• Herskind A, Greisen G, Nielsen JB. Early identification and intervention in cerebral palsy. Dev Med Child Neurol. 2015 Jan;57(1):29-36. doi: 10.1111/dmcn.12531. Epub 2014 Jul 9.

  PMID: 25041565 BACKGROUND

• Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.

  PMID: 28715518 BACKGROUND

• Lemon RN. Descending pathways in motor control. Annu Rev Neurosci. 2008;31:195-218. doi: 10.1146/annurev.neuro.31.060407.125547.

  PMID: 18558853 BACKGROUND

• Cioni G, D'Acunto G, Guzzetta A. Perinatal brain damage in children: neuroplasticity, early intervention, and molecular mechanisms of recovery. Prog Brain Res. 2011;189:139-54. doi: 10.1016/B978-0-444-53884-0.00022-1.

  PMID: 21489387 BACKGROUND

• Frye RE, Rotenberg A, Ousley M, Pascual-Leone A. Transcranial magnetic stimulation in child neurology: current and future directions. J Child Neurol. 2008 Jan;23(1):79-96. doi: 10.1177/0883073807307972. Epub 2007 Dec 3.

  PMID: 18056688 BACKGROUND

• Chen CY, Georgieff M, Elison J, Chen M, Stinear J, Mueller B, Rao R, Rudser K, Gillick B. Understanding Brain Reorganization in Infants With Perinatal Stroke Through Neuroexcitability and Neuroimaging. Pediatr Phys Ther. 2017 Apr;29(2):173-178. doi: 10.1097/PEP.0000000000000365.

  PMID: 28350777 BACKGROUND

• Gillick BT, Gordon AM, Feyma T, Krach LE, Carmel J, Rich TL, Bleyenheuft Y, Friel K. Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide. Front Pediatr. 2018 Mar 16;6:56. doi: 10.3389/fped.2018.00056. eCollection 2018.

  PMID: 29616203 BACKGROUND

• Nemanich ST, Chen CY, Chen M, Zorn E, Mueller B, Peyton C, Elison JT, Stinear J, Rao R, Georgieff M, Menk J, Rudser K, Gillick B. Safety and Feasibility of Transcranial Magnetic Stimulation as an Exploratory Assessment of Corticospinal Connectivity in Infants After Perinatal Brain Injury: An Observational Study. Phys Ther. 2019 Jun 1;99(6):689-700. doi: 10.1093/ptj/pzz028.

  PMID: 30806664 BACKGROUND

• Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.

  PMID: 28216033 BACKGROUND

• Chen CY, Rich TL, Cassidy JM, Gillick BT. Corticospinal Excitability in Children with Congenital Hemiparesis. Brain Sci. 2016 Oct 20;6(4):49. doi: 10.3390/brainsci6040049.

  PMID: 27775599 BACKGROUND

• Roze E, Harris PA, Ball G, Elorza LZ, Braga RM, Allsop JM, Merchant N, Porter E, Arichi T, Edwards AD, Rutherford MA, Cowan FM, Counsell SJ. Tractography of the corticospinal tracts in infants with focal perinatal injury: comparison with normal controls and to motor development. Neuroradiology. 2012 May;54(5):507-16. doi: 10.1007/s00234-011-0969-5. Epub 2011 Oct 18.

  PMID: 22006424 BACKGROUND

• van der Aa NE, Northington FJ, Stone BS, Groenendaal F, Benders MJ, Porro G, Yoshida S, Mori S, de Vries LS, Zhang J. Quantification of white matter injury following neonatal stroke with serial DTI. Pediatr Res. 2013 Jun;73(6):756-62. doi: 10.1038/pr.2013.45. Epub 2013 Mar 11.

  PMID: 23478641 BACKGROUND

• Adde L, Rygg M, Lossius K, Oberg GK, Stoen R. General movement assessment: predicting cerebral palsy in clinical practise. Early Hum Dev. 2007 Jan;83(1):13-8. doi: 10.1016/j.earlhumdev.2006.03.005. Epub 2006 May 2.

  PMID: 16650949 BACKGROUND

• Yu YT, Hsieh WS, Hsu CH, Chen LC, Lee WT, Chiu NC, Wu YC, Jeng SF. A psychometric study of the Bayley Scales of Infant and Toddler Development - 3rd Edition for term and preterm Taiwanese infants. Res Dev Disabil. 2013 Nov;34(11):3875-83. doi: 10.1016/j.ridd.2013.07.006. Epub 2013 Sep 9.

  PMID: 24029804 BACKGROUND

• Peyton C, Yang E, Msall ME, Adde L, Stoen R, Fjortoft T, Bos AF, Einspieler C, Zhou Y, Schreiber MD, Marks JD, Drobyshevsky A. White Matter Injury and General Movements in High-Risk Preterm Infants. AJNR Am J Neuroradiol. 2017 Jan;38(1):162-169. doi: 10.3174/ajnr.A4955. Epub 2016 Oct 27.

  PMID: 27789448 BACKGROUND

• Romeo DM, Ricci D, Brogna C, Mercuri E. Use of the Hammersmith Infant Neurological Examination in infants with cerebral palsy: a critical review of the literature. Dev Med Child Neurol. 2016 Mar;58(3):240-5. doi: 10.1111/dmcn.12876. Epub 2015 Aug 25.

  PMID: 26306473 BACKGROUND

• Chen CY, Tafone S, Lo W, Heathcock JC. Perinatal stroke causes abnormal trajectory and laterality in reaching during early infancy. Res Dev Disabil. 2015 Mar;38:301-8. doi: 10.1016/j.ridd.2014.11.014. Epub 2015 Jan 9.

  PMID: 25577180 BACKGROUND

• Dean DC 3rd, Dirks H, O'Muircheartaigh J, Walker L, Jerskey BA, Lehman K, Han M, Waskiewicz N, Deoni SC. Pediatric neuroimaging using magnetic resonance imaging during non-sedated sleep. Pediatr Radiol. 2014 Jan;44(1):64-72. doi: 10.1007/s00247-013-2752-8. Epub 2013 Aug 6.

  PMID: 23917588 BACKGROUND

• Kowalski JL, Nemanich ST, Nawshin T, Chen M, Peyton C, Zorn E, Hickey M, Rao R, Georgieff M, Rudser K, Gillick BT. Motor Evoked Potentials as Potential Biomarkers of Early Atypical Corticospinal Tract Development in Infants with Perinatal Stroke. J Clin Med. 2019 Aug 13;8(8):1208. doi: 10.3390/jcm8081208.

  PMID: 31412592 BACKGROUND

• Fehlings D, Makino A, Church P, Banihani R, Thomas K, Luther M, Lam-Damji S, Vollmer B, Haataja L, Cowan F, Romeo DM, George J, Kumar S. The Hammersmith Infant Neurological Exam Scoring Aid supports early detection for infants with high probability of cerebral palsy. Dev Med Child Neurol. 2024 Sep;66(9):1255-1257. doi: 10.1111/dmcn.15977. Epub 2024 May 31. No abstract available.

  PMID: 38818710 BACKGROUND

• Casey CP, Sutter EN, Grimaldo A, Collins KM, Guerrero-Gonzalez J, McAdams RM, Dean DC 3rd, Gillick BT. Preservation of Bilateral Corticospinal Projections from Injured Hemisphere After Perinatal Stroke. Brain Sci. 2025 Jan 17;15(1):82. doi: 10.3390/brainsci15010082.

  PMID: 39851449 DERIVED

Related Links

• Link to ClinicalTrials.gov record of the pilot study which lead to current study

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Brain Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bernadette Gillick, PhD, MSPT

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernadette Gillick, PhD, MSPT

CONTACT

608-262-3079; bgillick@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 19, 2021
• Study Start: July 26, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months after publication of primary outcomes, and ending 5 years after that date
• Access Criteria: 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.

Locations

US (1)