Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02743728
Previous Study | Return to List | Next Study

Perinatal Stroke: Understanding Brain Reorganization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02743728
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : August 27, 2020
Sponsor:
Collaborators:
Cerebral Palsy Alliance
American Academy of Cerebral Palsy and Developmental Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but little is known about the resulting changes in the brain that eventually manifest as cerebral palsy (CP). More importantly, no therapy has been devised to mitigate these specific maladaptive changes leading to hemiplegic CP. However, motor signs that indicate the infant is beginning to develop CP often do not become evident for several months after the diagnosis of perinatal stroke. This delays therapy. We view the first several months after perinatal stroke as a "window of opportunity" because it is known to be a critical period of development. During this period, a well-designed intervention could minimize maladaptive changes in the brain. To design such a science-based rehabilitation protocol for young infants during this window of opportunity, we must first develop efficient and reliable assessments to detect and measure maladaptive cortical reorganization in the brain.

Therefore, the main purpose of this study is to examine early brain reorganization in infants 3-12 months of age corrected for prematurity with perinatal stroke using magnetic resonance imaging (MRI) and non-invasive transcranial magnetic stimulation (TMS). In addition, the association between the brain reorganization and motor outcomes of these infant participants will be identified.

In this study, the MRI scans will include diffusion tensor imaging (DTI) - an established method used to investigate the integrity of pathways in the brain that control limb movement. Infants will be scanned during nature sleeping after feeding. The real scanning time will be less than 38 minutes. TMS is a painless, non-surgical brain stimulation device which uses principles of electromagnetic induction to excite cortical tissue from outside the skull. Using TMS as a device to modulate and examine cortical excitability in children with hemiparetic CP and in adults has been conducted previously. In this infant study, we will assess cortical excitability from the motor cortex of both the ipsilesional and contralesional hemispheres under the guidance of a frameless stereotactic neuronavigation system. Additionally, the investigators will assess infants' movement quality using an age-appropriate standardized movement assessment. This will allow the investigators to examine the relationship between measures of motor pathway integrity and early signs of potential motor impairment.

We will longitudinally follow enrolled infants up to 24 months of age corrected for prematurity, and complete repeat assessments at 12 and 24 months corrected age to assess how infants develop over time after perinatal stroke.

Modified protocol as of October 2019:

  1. No longer doing longitudinal followup
  2. Evaluate relationship between legion, heterogeneity, and cortical motor excitability and circuitry
  3. Using MRI and computational modeling to estimate individualized electric fields from each infants neuroanatomy

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: Magnetic Resonance Imaging Device: Transcranial Magnetic Stimulation Behavioral: General Movement Assessment Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All Infants
Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.
Device: Magnetic Resonance Imaging
Anatomical and Diffusion Tensor Imaging Analysis.

Device: Transcranial Magnetic Stimulation
Assessment of brain (cortical) excitability

Behavioral: General Movement Assessment
Spontaneous movement assessment of infant while lying in unperturbed state.




Primary Outcome Measures :
  1. Cortical excitability (map volume) of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke [ Time Frame: Day 2, 2 hour assessment performed once in the entire study ]
    TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimate time of TMS assessment is around 2 hours during Visit 2.


Secondary Outcome Measures :
  1. Bilateral corticospinal tract integrity (fractional anisotropy) derived from diffusion tensor imaging [ Time Frame: Day 1, 2 hour Imaging Session performed once in the entire study ]
    Magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) will be performed when infants are sleeping with a real scanning time of 38 minutes during visit 1.

  2. The association of movement quality (atypical vs. typical movement) with ipsilesional cortical excitability and relative tract integrity between hemispheres (ratio of FA values) [ Time Frame: Day 2, 15 minute assessment performed once in the entire study ]
    The movement quality will be assessed by general movement assessment (GMA). GMA requires 5-10 minutes video taping when infants are placed in spine position for scoring.

  3. Recording adverse events during TMS cortical mapping and MRI scanning of infants with perinatal stroke [ Time Frame: Day 1 during 2 hour session, and Day 2 during 2 hour 15 minute sessions once during the entire study ]
    Assessment of vital signs changes and pain/stress responses during both MRI and TMS assessment during visit 1 and visit 2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth diagnosis of unilateral perinatal stroke by cranial ultrasound, computer tomography (CT) or magnetic resonance imaging (MRI)
  • Corrected gestational age between 3 and 24 months of age for both infants with stroke and typically developing infants

Exclusion Criteria:

  • Metabolic Disorders
  • Neoplasm
  • Disorders of Cellular Migration and Proliferation
  • Acquired Traumatic Brain Injury
  • Received surgeries that may constraint current spontaneous movements
  • Indwelling metal or incompatible medical devices
  • Received surgeries that may constraint current spontaneous movements
  • Other neurologic disorders unrelated to stroke
  • Small for gestational age (SGA): Infants are smaller in size than normal for the gestational age
  • Apneic episodes and syncope (known heart defects) for the safety of participants in the stud.
  • Genetic disorders
  • Uncontrolled seizures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743728


Contacts
Layout table for location contacts
Contact: Maureen E Boxrud, BA 612-626-6415 brown029@umn.edu

Locations
Layout table for location information
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Maureen E Boxrud, BA    612-626-6415    brown029@umn.edu   
Sponsors and Collaborators
University of Minnesota
Cerebral Palsy Alliance
American Academy of Cerebral Palsy and Developmental Medicine
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT University of Minnesota
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02743728    
Other Study ID Numbers: PT-2015-23643
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Keywords provided by University of Minnesota:
perinatal stroke
transcranial magnetic stimulation
magnetic resonance imaging
diffusion tensor imaging
non-invasive brain stimulation
infant
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations