Studies

Baby in lab

Baby Brain Recovery Study – Now Recruiting Participants

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Long Title: Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery through Neuroexcitability, Neuroimaging and Motor Development
Eligibility: 0-6 months of age, history of early brain injury, accompanied by a parent/legal guardian.
Please contact our team to help determine eligibility and learn more about the study
Brief Explanation: This study will assess, over the first two years of life, concurrent recovery and development of the infant brain and resultant function after perinatal stroke. 
Tasks: There are three elements to this study: Imaging, Connectivity, and Movement.
Imaging will consist of taking photos of the child’s brain (MRI) while they are naturally sleeping. We test brain connectivity with brief and painless pulses applied from a device that rests gently on your baby’s head (TMS). We assess how your baby is moving and developing by observing your baby’s movement. Check out the
Tests and Interventions page on our website to learn more about these methods.  
Time: We offer two enrolment options:
Two-Year Option:
Participation occurs over the first two years of your child’s life at 4-5 specific growth timepoints.
Visit time points:  (corrected for prematurity): 0-2, 3-6, 12, 18, and 24 months
One-Visit Option:
Participation occurs for one timepoint when your child is 3-6months of age. 
Planning Your Visit: The visits will take place at the University of WisconsinMadison
Waisman Center, 1500 Highland Avenue.  
Free parking will be provided on the day of your visit. 
Compensation: $50 at each session, for a total of $450 over the two years of participation.
Travel reimbursement is available.
Current Status: Now recruiting children with early brain injury
Study Brochure
Study Flyer
More Information: ClinicalTrials.gov (NCT number): NCT05013736
Study Summary: This is a one-page overview of the protocol paper.
Protocol Paper: This is the published protocol of the study
Contact Us: Interested in participating? Questions about the study? Call us at 608-381-2699 or email us at brainrecovery@pediatrics.wisc.edu.
Dates: September 2021-June 2025
Project Number:   7R01HD098202-02
Funding Agency:  National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Neurological Disorders and Stroke

I-ACQUIRE – Now recruiting participants

Long Title: Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE) 
Eligibility: Your infant or toddler may be eligible if he or she: 

  • Had a stroke in the newborn period or was thought to have had a stroke even before birth. 
  • Shows motor weakness or poor control of movements on one side of the body (often diagnosed as hemiparesis) 
  • Will be between 8 and 36 months old when treatment is received 
  • Program staff can speak with you to review all eligibility requirements in detail. 

Please contact our team to help determine eligibility and learn more about the study 

Brief Explanation: This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol – I-ACQUIRE – to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). 
Tasks: I-ACQUIRE is a form of infant and toddler rehabilitation. Two dosages are being evaluated compared with the treatments that infants and toddlers with hemiparesis typically receive. Both dosages of I-ACQUIRE therapy involve 5 days a week for 4 weeks in a row, provided by a therapist trained in I-ACQUIRE. The general name for this form of therapy is constraint-induced movement therapy (CIMT). 
Time: Your child will be assigned by chance to 1 of 3 groups: 

  • Group 1: I-ACQUIRE 6 hours daily, 5 days per week for 4 weeks. 
  • Group 2: I-ACQUIRE 3 hours daily, 5 days per week for 4 weeks. 
  • Group 3: Continue the current therapy your child normally receives. Six months later participants in this group can choose to be assigned by chance to the high or low dose of I-ACQUIRE therapy. 
Planning Your Visit: The evaluation and casting visits will take place at the University of Wisconsin–Madison
Waisman Center, 1500 Highland Avenue.
Free parking will be provided on the day of your visit.  Therapy is provided in your home, a homelike setting (for families who need to relocate for the month of therapy), or a homelike setting in a child-care center or early intervention program that your child attends. 
Current Status: Now recruiting participants  
Study Flyer
More Information: ClinicalTrials.gov (NCT number): NCT03910075 
Website: https://www.nihstrokenet.org/trials/i-acquire/home  
Contact Us: Interested in participating? Questions about the study? Call us at 608-381-2699 or email us at brainrecovery@pediatrics.wisc.edu.
Dates: February 2019 October 2025 (or until enrollment is met) 
Project Number:  1U01NS106655-01A1 
Funding Agency: National Institutes of Health, National Institute of Neurological Disorders and Stroke 

Pediatric Brain and Movement Study – Recruitment Closed

Long Title: Teleneuromodulation in Children with Cerebral Palsy (tDCS) Transcranial Direct Current Stim
Eligibility: 8-17 years old, hemiparetic cerebral palsy with a history of perinatal stroke/brain bleed
Brief Explanation: Families will work with our team to perform a first-of-its-kind remote, in-home teleneuromodulation study.
Tasks: Virtually meet with the study team to complete each session in the comfort of your own home; set up the headgear; rest during sessions of stimulation (tDCS) through the sponge pads; move small blocks using one hand; complete surveys
Time:  5 consecutive days (about 1 hour per day)
Compensation: $100
Current Status: Recruitment Closed

Study Flyer

More Information: ClinicalTrials.gov (NCT Number): NCT05071586

Protocol Paper: This is the published protocol of the study

Contact Us: Interested in participating? Questions about the study? Call us at 608-381-2699 or email us at pnl@waisman.wisc.edu
Dates: May 2021-May 2024
Funding Agency: 2020 American Academy of Cerebral Palsy and Developmental Medicine Research Grant, funded by the NIH
through the National Pediatric Rehabilitation Resource Center
Related Publications: Final Publication: Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy

Remotely Monitored Transcranial Direct Current Stimulation in Pediatric Cerebral Palsy: Open Label Trial Protocol

Feasibility of remote transcranial direct current stimulation for pediatric cerebral palsy during the COVID-19 pandemic

Transcranial direct current stimulation and constraint-induced therapy in cerebral palsy: a randomized, blinded, sham-controlled clinical trial

 

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Teleneuromodulation in Children with Cerebral Palsy

Title: Teleneuromodulation in Children with Cerebral Palsy (tDCS)
 Transcranial Direct Current Stim
Dates: May 2021-May 2024
Funding Agency: 2020 American Academy of Cerebral Palsy and Developmental Medicine Research Grant, funded by the NIH
through the National Pediatric Rehabilitation Resource Center
Brief Explanation: Families will work with our team to perform a first-of-its-kind remote, in-home teleneuromodulation study.
Eligibility: 8-17 years old, history of perinatal stroke/brain bleed
Tasks: Virtually meet with the study team to complete each session in the comfort of your own home; set up the headgear; rest during sessions of stimulation (tDCS) through the sponge pads; move small blocks using one hand; complete surveys
Time: 5 consecutive days (about 1 hour per day)
Compensation: $100
Current Status: Recruiting
Contact Us: Interested in participating? Questions about the study? Call us at 608-381-2699 or email us at pnl@waisman.wisc.edu

Perinatal Brain Injury: Identifying Cortical Excitability and Circuitry through Multi-Modal Assessment

Title: Perinatal Brain Injury: Identifying Cortical Excitability and Circuitry through Multi-Modal Assessment
Dates: August 2019-November 2022
Project #: NIH 1R21HD097575-01A1
Funding Agency:
National Institutes of Health/NICHD
Brief Explanation: To identify correlations between brain structure, function and computational modeling in children with perinatal stroke.
Current Status: Recruitment Closed, Analysis in Process

Studies During Covid-19 Pandemic

“Disrupted access to therapies and impact on well-being during the COVID-19 pandemic for children with motor impairment and their caregivers” Many children with childhood-onset disabilities affecting physical and cognitive function need early and continuous therapies to address their needs and optimize outcomes. COVID-19 disrupted access to therapy services, with unknown impact on child and caregiver well-being. Caregivers completed an online survey regarding the impact of COVID-19 on access to therapy services and physical/mental health. We found that access to pediatric rehabilitation therapies was disrupted for the majority of families during the first few months of the COVID-19 pandemic, with Telehealth options available to some but not all families. Disrupted access may be related to physical and mental health impacts such as decline in mobility and increased caregiver stress. With the expansion of telehealth, caregiver and child feedback should be incorporated to optimize benefit.

“Assessing the feasibility of at-home neurorehabilitation: Applications for children with cerebral palsy and limited mobility during the COVID-19 Mandate”. The COVID-19 stay at home mandate has changed the landscape of rehabilitation, and will likely require an increased capacity to deliver effective remote rehabilitation. Our lab and others have shown that neuromodulation may be an effective strategy to enhance the effects of standard rehabilitation interventions. This study was an initial step in the assessment of feasibility to perform mock remote neuromodulation (tDCS-transcranial direct current stimulation) in children with cerebral palsy (CP) and has since been published in Brain Stimulation. We found that parent-child teams have the ability to perform the steps required for future remote tDCS. Our next study, now funded by an American Academy of Cerebral Palsy NIH C-PROGRESS grant, will assess the safety, tolerability and feasibility of remotely monitored real tDCS for children with CP.