Studies
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| Long Title: | Perinatal Stroke: Longitudinal Assessment of Infant Brain Organization and Recovery through Neuroexcitability, Neuroimaging and Motor Development |
| Eligibility: | 0-24 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: Multi-Visit Option: Participation occurs over the first two years of your child’s life at 4 specific growth timepoints. Visit time points: (corrected for prematurity): 3-6, 12, 18, and 24 months One-Visit Option: Participation occurs for one timepoint when your child is 3-24 months of age. |
| Planning Your Visit: | The 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. |
| Compensation: | $100 at each session, for a total of $400 over the multi-visit 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 2027 |
| 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 |
| Long Title: | Motion Robust Relaxometry for Infant Imaging |
| Eligibility: | 0-24 months of age, accompanied by a parent/legal guardian. Please contact our team to help determine eligibility and learn more about the study |
| Brief Explanation: | The purpose of this research study is to develop new approaches to study brains with magnetic resonance imaging (MRI) with the overall goal of improving imaging studies of infants and young children. Specifically, we aim to create a more pleasant experience by making the process faster, quieter, and less sensitive to motion. The new methods may eventually help with the diagnosis and monitoring of diseases. |
| Tasks: | There are two elements to this study: Imaging and Developmental Assessments. Imaging will consist of taking photos of the child’s brain (MRI) while they are naturallysleeping (during a nap or evening sleep). Developmental assessments will consist of observing your baby’s movement to assess how your baby is moving and developing. |
| Time: | Participation involves up to two visits to the Waisman Center. The imaging visit will take ~2-4 hours and the developmental assessment visit will take 1 hour (~3-5 hours total). These visits may be completed on the same day or on two separate days no more than five days apart. |
| Planning Your Visit: | The 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. |
| Compensation: | Up to $75 ($50 for imaging, $25 for developmental assessments). |
| Current Status: | Recruiting children for MRI visit only (no developmental assessments). |
| More Information: | Study Summary Study Flyer |
| Contact Us: | Interested in participating? Questions about the study? Call us at 608-516-4558 or email us at relaxmri@bi.wisc.edu. |
| Dates: | March 2022-July 2026 |
| Project Number: | UW-Madison IRB: 2022-0043. NIH: 5R01HD108868-03 |
| Funding Agency: | National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development |
| Long Title: | Harnessing Early Neuroplasticity in Infants With Perinatal Brain Injury: A Pilot Study of Combined Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) Paired With Constraint-Induced Movement Therapy (CIMT) and Transcranial Magnetic Stimulation (TMS) |
| Eligibility: | Children 8–24 months of age with a history of perinatal brain injury or weakness affecting one side of the body. Additional eligibility criteria will be reviewed during a screening call. |
| Brief Explanation: | This study combines intervention of Constraint-Induced Movement Therapy (CIMT) and transcutaneous auricular vagus nerve stimulation (taVNS) in infants who use one side of their body differently after a brain injury. The study will explore changes in arm and hand function and use a non-invasive assessment called single-pulse transcranial magnetic stimulation (spTMS) to look at communication between the brain and muscles and better understand responses to therapy. |
| Tasks: | Participation begins with a brief screening call. Eligible families will complete three assessment visits (before treatment, immediately after treatment, and three months later). Assessments include non-invasive spTMS testing and motor development evaluations. Children will also participate in a two-week therapy program. Therapy sessions occur 4 hours per day, 5 days per week, for a total of 40 therapy hours. The total study duration is approximately 3.5 months from enrollment through follow-up. |
| Planning Your Visit: | The 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. |
| Compensation: | Families will be paid up to $150 for completing study assessments ($50 after the baseline assessment, $50 after the post-intervention assessment, and $50 after the 3-month follow-up). |
| Current Status: | Now recruiting children with early brain injury Study Flyer |
| Contact Us: | Interested in participating? Questions about the study? Call us at 608-381-2699 or email us at brainrecovery@pediatrics.wisc.edu. |
| Dates: | August 2026 – June 2027 |
| Funding Agency: | Institute for Clinical and Translational Research (ICTR) Translational Basic & Clinical Research (TBCR) Pilot Award |
Past Studies
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| 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:
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:
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| 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: | Recruitment Closed |
| More Information: | ClinicalTrials.gov (NCT number): NCT03910075 Website: https://www.nihstrokenet.org/trials/i-acquire/home |
| Dates: | February 2019 – October 2025 |
| Project Number: | 1U01NS106655-01A1 |
| Funding Agency: | National Institutes of Health, National Institute of Neurological Disorders and Stroke |
| Title: | Teleneuromodulation in Children with Cerebral Palsy (tDCS) |
| 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: | Recruitment closed |
| 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 |
| “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. |