Perinatal Brain InjuryNCT07738432
Neuro-MoD: Neuroplasticity With Motor Development
A study testing Constraint-Induced Movement Therapy (CIMT) and Transcutaneous auricular vagus nerve stimulation (taVNS) in people with Perinatal Brain Injury, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 24 months
- Conditions the study is for
- Perinatal Brain Injury
- What is being tested?
- Constraint-Induced Movement Therapy (CIMT) and Transcutaneous auricular vagus nerve stimulation (taVNS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- GMFCS level V
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53715
Bernadette Gillick, PhD, MSPT, 608-262-7457, bgillick@wisc.edu
Bernadette Gillick, PhD, MSPT
About this study
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)
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.
Read the detailed description
Primary Objective • To evaluate the feasibility of using spTMS to elicit motor-evoked potentials (MEPs) in infants with hemiplegic cerebral palsy (CP) due to perinatal brain injury and to determine whether baseline MEP characteristics predict motor response to a 40-hour intervention combining taVNS with CIMT.
Exploratory Objective:
- To investigate neuroplastic changes in cortical motor circuitry associated with taVNS-paired CIMT by examining longitudinal changes in MEP topography and corresponding motor function.
- Conditions
- Perinatal Brain Injury
- Being tested
- Constraint-Induced Movement Therapy (CIMT), Transcutaneous auricular vagus nerve stimulation (taVNS)
- Keywords
- hypoxic-ischemic encephalopathy (HIE), perinatal stroke, intracranial hemorrhage, hemiplegic cerebral palsy (CP), Constraint-Induced Movement Therapy (CIMT), transcutaneous auricular vagus nerve stimulation (taVNS), motor-evoked potentials (MEPs), Single Pulse Transcranial Magnetic Stimulation (spTMS)
- Medical subject headings
- Hypoxia-Ischemia, Brain, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy (CIMT)Behavioural
CIMT involves placing a mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions.
Transcutaneous auricular vagus nerve stimulation (taVNS)Device
Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.
| Study group | Role | What they receive |
|---|---|---|
| Infants and Toddlers with Perinatal Brain Injury | Experimental | 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. Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT); Device: Transcutaneous auricular vagus nerve stimulation (taVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
Motor-evoked potentials (MEPs) are electrical responses recorded from a muscle following a brief magnetic pulse delivered to the brain using single-pulse transcranial magnetic stimulation (spTMS). This outcome measures the proportion of participants in whom a reliable MEP can be elicited at baseline and serves as a measure of the feasibility of assessing corticospinal connectivity in infants with perinatal brain injury.
Measured: baseline (Day 1)
Completion rate of spTMS sessions
This outcome measures the proportion of planned spTMS assessment sessions that are successfully completed at baseline, post-intervention, and 3-month follow-up. Completion rates will be used to evaluate the feasibility, tolerability, and practicality of conducting repeated spTMS assessments in infants and toddlers with perinatal brain injury.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Secondary outcomes (6)
Baseline MEP Amplitude
MEP amplitude will be reported in millivolts (mV), measured from electromyography recordings of the target muscle.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Percent change in Mini-Assisting Hand Assessment (mini-AHA) score from baseline to end of treatment
The mini-AHA evaluates how effectively infants with unilateral upper extremity impairment use their affected hand during bimanual play activities. Scores are reported on a standardized 0-100 scale, with higher scores indicating greater functional use of the affected hand and lower scores indicating less functional use.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline
This is a measure of movement, scored in several domains: dissociated movement (joint mobility), grasp (holding and manipulating objects), protective extension (reflex reactions), and weight bearing assessments. It is scored from 0 to 100 where higher scores mean better movement.
Change in QUEST score from baseline will be used to assess changes in upper extremity function following the intervention.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Fine Motor subtest evaluates fine motor skills, including reaching, grasping, object manipulation, and hand-eye coordination. Scores are standardized based on age and range from 1 to 19, with a normative mean of 10 and standard deviation of 3. Scores in the range of 8-12 are generally considered within the typical range for age. Higher scores indicate more advanced motor development.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)
The Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Gross Motor subtest evaluates gross motor skills, including posture, sitting, crawling, standing, walking, and other age-appropriate movement abilities. Scores are standardized based on age and range from 1 to 19, with a normative mean of 10 and standard deviation of 3. Scores in the range of 8-12 are generally considered within the typical range for age. Higher scores indicate more advanced motor development.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Gross Motor Function Measure (GMFM-88)
The Gross Motor Function Measure-88 (GMFM-88) evaluates gross motor function across five domains: lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. Items are scored on a 4-point scale and converted to dimension and total scores ranging from 0 to 100. Higher scores indicate better gross motor function and greater ability to perform age-appropriate motor activities.
Measured: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette Gillick, PhD, MSPT, Principal investigator, UW School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738432
- Sponsor's protocol ID
- 2026-0790
- Other IDs
- Protocol Version 6/17/26, SMPH/Pediatrics/Dev & Reh Med, ICTR Pilot Award
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07738432
- Acronym / sponsor ID
- 2026-0790
- Conditions
- Perinatal Brain Injury
- Keywords
- hypoxic-ischemic encephalopathy (HIE), perinatal stroke, intracranial hemorrhage, hemiplegic cerebral palsy (CP), Constraint-Induced Movement Therapy (CIMT), transcutaneous auricular vagus nerve stimulation (taVNS), motor-evoked potentials (MEPs), Single Pulse Transcranial Magnetic Stimulation (spTMS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective • To evaluate the feasibility of using spTMS to elicit motor-evoked potentials (MEPs) in infants with hemiplegic cerebral palsy (CP) due to perinatal brain injury and to determine whether baseline MEP characteristics predict motor response to a 40-hour intervention combining taVNS with CIMT.
Exploratory Objective:
- To investigate neuroplastic changes in cortical motor circuitry associated with taVNS-paired CIMT by examining longitudinal changes in MEP topography and corresponding motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants and Toddlers with Perinatal Brain Injury | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT), Device: Transcutaneous auricular vagus nerve stimulation (taVNS)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. |
Who may qualify
- Ages
- 8 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- GMFCS level V
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT)CIMT involves placing a mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions. | Behavioural | Infants and Toddlers with Perinatal Brain Injury |
| Transcutaneous auricular vagus nerve stimulation (taVNS)Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills. | Device | Infants and Toddlers with Perinatal Brain Injury |
Primary outcome
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
Time frame: baseline (Day 1)
Motor-evoked potentials (MEPs) are electrical responses recorded from a muscle following a brief magnetic pulse delivered to the brain using single-pulse transcranial magnetic stimulation (spTMS). This outcome measures the proportion of participants in whom a reliable MEP can be elicited at baseline and serves as a measure of the feasibility of assessing corticospinal connectivity in infants with perinatal brain injury.
Completion rate of spTMS sessions
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
This outcome measures the proportion of planned spTMS assessment sessions that are successfully completed at baseline, post-intervention, and 3-month follow-up. Completion rates will be used to evaluate the feasibility, tolerability, and practicality of conducting repeated spTMS assessments in infants and toddlers with perinatal brain injury.
6 secondary outcomes
Baseline MEP Amplitude
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Percent change in Mini-Assisting Hand Assessment (mini-AHA) score from baseline to end of treatment
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Gross Motor Function Measure (GMFM-88)
Time frame: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy
Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia
RecruitingObservational study
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Not yet recruitingPhase 1/2
Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy
Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bernadette Gillick, PhD, MSPT principal investigator
UW School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-Induced Movement Therapy (CIMT) and Transcutaneous auricular vagus nerve stimulation (taVNS) in people with Perinatal Brain Injury, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernadette Gillick, PhD, MSPT (608-262-7457, bgillick@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence) (time frame: baseline (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.