Combined nerve stimulation and movement therapy for infants with perinatal brain injury
Tests ear nerve stimulation with arm therapy in infants with perinatal brain injury.
Key facts
- Who runs it
- University of Wisconsin, Madison
- Where
- Madison, United StatesSee the site
- Trial code
- Registry title
- Neuro-MoD: Neuroplasticity With Motor Development
- Status
- Recruiting
- People taking part
- 8 people, planned
- Started
- Oct 2026
- Expected to end
- Jun 2027
- Type of study
- Interventional
- Treatments tested
- Constraint-Induced Movement Therapy (CIMT)
- Transcutaneous auricular vagus nerve stimulation (taVNS)
- Record updated
- 19 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for babies and toddlers aged 8 to 24 months who have weakness in one arm or hand because of a brain injury around birth.
- Age
- 8 to 24 months
- Sex
- All sexes can join.
- Disease stage
- Hemiplegia or clear weakness of one upper limb caused by perinatal brain injury. Motor function level (GMFCS) I-IV.
- Earlier treatment
- Must not have had constraint-induced movement therapy (CIMT) in the past 3 months.
Main reasons for not taking part
- GMFCS level V
- Severe motor impairment or involvement of all four limbs
- Uncontrolled seizure disorder
- Cardiomyopathy
- Severe congenital malformations
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Infants aged 8 to 24 months, diagnosed with hemiplegia or with an evident unilateral upper-limb weakness due to perinatal brain injury
- Gross Motor Function Classification System (GMFCS) level I-IV
- Infants who have not received previous CIMT in the preceding 3 months
- Able to make consecutive appointments for assessments and intervention over 2 weeks, and complete the 3-month follow-up
Who cannot take part
- Prior CIMT within the past 3 months
- Severe motor impairment/quadriplegic involvement
- Uncontrolled seizure disorders, cardiomyopathy, severe congenital malformations,
- significant sensory impairments, or conditions preventing safe participation in therapy sessions
- GMFCS level V
Where in United States
- University of Wisconsin - MadisonMadison, United StatesContact: Bernadette Gillick, PhD, MSPTTaking people
About the trial
What the trial wants to find out
This study is for infants and toddlers between 8 and 24 months old who use one arm and/or hand differently following a perinatal brain injury. This is a time when investigators think they can best help improve how the brain controls movement. Investigators are testing whether the combination of transcutaneous auricular vagus nerve stimulation (taVNS) with 40 hours of constraint-induced movement therapy (CIMT) can help infants move their weaker arm and hand better and make the brain pathways for movement stronger.
The group in the trial
- Infants and Toddlers with Perinatal Brain InjuryTreatment being tested
Therapy sessions in this study will take 4 hours a day, 5 days a week for 2 weeks (40 hours total CIMT). Sticker like sensors (electrodes) are placed just inside and outside the child's left earlobe at the start of the session to deliver the taVNS. During daily therapy sessions, the taVNS will be on whenever the child moves their free arm, for up to 2.5 minutes at a time.
Treatment: Constraint-Induced Movement Therapy (CIMT) and Transcutaneous auricular vagus nerve stimulation (taVNS)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Harnessing Early Neuroplasticity in Infants With Perinatal Brain Injury: A Study of Combined Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) Paired With Constraint Induced Movement Therapy (CIMT) and Transcranial Magnetic Stimulation (TMS)
- Plain-language title
- Combined nerve stimulation and movement therapy for infants with perinatal brain injuryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 October 2026