- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013736
Baby Brain Recovery Study
Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery Through Neuroexcitability, Neuroimaging and Motor Development
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.
Study Overview
Status
Conditions
Detailed Description
Perinatal stroke has disabling consequences; 50-75% of individuals will develop life-long motor impairment, and 10-60% will also have cognitive deficits. These deficits lead to challenges in the school and home environments, with decreased likelihood of employment and independence and increased caregiver burden. Additionally, perinatal stroke is one of the primary causes of cerebral palsy (CP), a chronic and disabling neurological condition affecting motor function.
The first two years of life constitute a critical period of brain development and heightened neuroplasticity. There is now a consensus that, due to brain plasticity and rapid development, providing an early intervention may result in optimal recovery and lower costs of care. Unfortunately, researchers still have only limited understanding of how the brain develops after perinatal stroke and as a result CP diagnoses are typically not made until two years of age. There is an urgent need for very early diagnosis, prognosis and understanding of mechanisms in order to develop novel early interventions to improve outcomes in perinatal stroke with resultant CP.
Integrating study team's experience in studying and caring for this vulnerable infant stroke population, they propose to use non-invasive brain stimulation, neuroimaging, and behavioral assessments to analyze associations between development patterns, especially in the CST, and potential diagnosis of CP.
Specific aims of this study are:
- Aim 1. Map the presence and excitability of corticospinal pathways.
- Aim 2. Map the structural integrity and connectivity of corticospinal pathways.
- Aim 3. Compare motor outcomes from clinical behavioral assessments against corticospinal tract excitability and integrity.
- Aim 4. Identify the association between brain white-matter connectivity and general movements.
- Aim 5. Identify the association between corticospinal circuitry and general movements.
Protocol Amendment approved on 10/22/2021 removes TMS intervention and outcomes, adds a study time point at 0-2 months, and lowers the eligibility age to term.
Protocol Amendment approved on 12/21/2021 adds the TMS intervention back.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bernadette Gillick, PhD, MSPT
- Phone Number: 608-262-3079
- Email: bgillick@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin School of Medicine and Public Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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, or periventricular leukomalacia
- Diagnosis of hypoxic ischemic encephalopathy
- English-speaking parent/legal guardian (able to provide consent)
Exclusion Criteria:
- Other neurologic disorders unrelated to perinatal stroke
- Metabolic disorders
- Neoplasm
- Disorders of Cellular Migration and Proliferation
- Acquired Traumatic Brain Injury
- Received surgeries that may constrain current spontaneous movements
- Indwelling metal or incompatible medical devices, or other contraindications for MRI or TMS assessment
- Apneic episodes and syncope (known heart defects) for the safety of participants in the study
- Supplemental ventilation
- Uncontrolled seizure
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
Other Names:
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
Time Frame: 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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
Time Frame: 1 ±1 month
|
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
Time Frame: 3 ±1 months
|
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) score
Time Frame: 1 ±1 month
|
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. |
1 ±1 month
|
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) score
Time Frame: 3-6 months (one visit in this time frame)
|
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. |
3-6 months (one visit in this time frame)
|
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) score
Time Frame: 12±1 months
|
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. |
12±1 months
|
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) score
Time Frame: 18±1 months
|
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. |
18±1 months
|
Behavioral assessments: Hammersmith Infant Neurological Examination (HINE) score
Time Frame: 24±1 months
|
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. |
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)
|
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
Time Frame: 12±1 months
|
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
Time Frame: 18±1 months
|
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
Time Frame: 24±1 months
|
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)
Time Frame: 1±1 month
|
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)
Time Frame: 3-6 months (one visit in this time frame)
|
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)
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
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
Time Frame: 1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
Respiration rate will be measured as breaths/minute.
|
1 ±1 month, 3-6 months (one visit in this time frame), 12±1 months, 18±1 months, 24±1 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernadette Gillick, PhD, MSPT, University of Wisconsin, Madison
Publications and helpful links
General Publications
- 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. Erratum In: JAMA Pediatr. 2017 Sep 1;171(9):919.
- 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.
- 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.
- Lemon RN. Descending pathways in motor control. Annu Rev Neurosci. 2008;31:195-218. doi: 10.1146/annurev.neuro.31.060407.125547.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0412
- SMPH/PEDIATRICS/PEDIATRICS (Other Identifier: UW Madison)
- A536761 (Other Identifier: UW Madison)
- 7R01HD098202-02 (U.S. NIH Grant/Contract)
- Protocol ver 13 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Perinatal Stroke
-
UMC UtrechtM.D. Anderson Cancer Center; The University of Texas Health Science Center... and other collaboratorsCompletedNeonatal Stroke | Perinatal Arterial Ischemic StrokeNetherlands
-
UMC UtrechtThe Hospital for Sick Children; Alberta Children's HospitalRecruitingPerinatal Stroke | Neonatal Stroke | PAISNetherlands
-
University of AlbertaBrain CanadaRecruitingPerinatal StrokeCanada
-
University of AlbertaAlberta Innovates Health SolutionsCompleted
-
University Hospital, Clermont-FerrandCompletedPregnancy Related | Sedentary Behavior | Sedentary Time | Perinatal Problems | Morbidity;PerinatalFrance
-
Weill Medical College of Cornell UniversityRecruitingPerinatal Depression | Perinatal AnxietyUnited States
-
Fundación IVIRecruitingPerinatal DisorderSpain, Italy, United Kingdom
-
Massachusetts General HospitalPositive Intelligence Inc.Not yet recruitingPerinatal Depression | Perinatal Anxiety
-
Virginia Polytechnic Institute and State UniversityMedical University of South Carolina; Stanford University; Ohio State University and other collaboratorsRecruitingHemiparesis | Perinatal StrokeUnited States
Clinical Trials on Magnetic Resonance Imaging
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Recruiting
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingProstate Adenocarcinoma | Prostate CarcinomaUnited States
-
University of California, San FranciscoTerminatedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic... and other conditionsUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingIntracranial NeoplasmUnited States
-
University of MichiganPhilips Healthcare; General ElectricCompleted
-
American College of Radiology Imaging NetworkNational Cancer Institute (NCI)Completed
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Healthy SubjectUnited States
-
Stanford UniversityTerminatedLaryngeal Neoplasms | Head and Neck Cancers | Larynx CancerUnited States
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)CompletedBreast CancerUnited States