Neuro-MoD: Neuroplasticity With Motor Development
11. september 2026 oppdatert av: University of Wisconsin, Madison
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
8
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bernadette Gillick, PhD, MSPT
- Telefonnummer: 608-262-7457
- E-post: bgillick@wisc.edu
Studer Kontakt Backup
- Navn: Arun Karumattu Manattu, PhD
- Telefonnummer: 608-381-2699
- E-post: karumattuman@wisc.edu
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Infants and Toddlers with Perinatal Brain Injury
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.
|
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.
Stimulates a nerve by the ear, called the vagus nerve, that may enhance learning motor skills.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants in whom MEPs can be elicited reliably at baseline (presence/absence)
Tidsramme: 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.
|
baseline (Day 1)
|
|
Completion rate of spTMS sessions
Tidsramme: 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.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Baseline MEP Amplitude
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
MEP amplitude will be reported in millivolts (mV), measured from electromyography recordings of the target muscle.
|
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
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
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.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
Change in Quality of Upper Extremity Skills Test (QUEST) score from baseline
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
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. |
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
Bayley Scales of Infant Development (Bayley-4; Fine Motor subtest)
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
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.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
Bayley Scales of Infant Development (Bayley-4; Gross Motor subtests)
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
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.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
Gross Motor Function Measure (GMFM-88)
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
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.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
MEP Amplitude
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Motor-evoked potential (MEP) amplitude measures the strength of the muscle response produced after a brief magnetic pulse is applied to the brain using single-pulse transcranial magnetic stimulation (spTMS).
Larger amplitudes indicate stronger communication between the brain and the target muscle.
MEP amplitude will be reported in millivolts (mV).
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
MEP Threshold
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Motor-evoked potential (MEP) threshold is the minimum level of magnetic stimulation needed to produce a muscle response.
Lower thresholds generally indicate that the pathway between the brain and muscle can be activated more easily.
MEP threshold will be reported as a percentage of maximum stimulator output (%MSO).
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
|
Cortical Map Topography
Tidsramme: baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Cortical map topography describes the location and distribution of brain areas that produce muscle responses when stimulated using single-pulse transcranial magnetic stimulation (spTMS).
Changes in the size, location, or organization of these areas over time may reflect changes in brain connectivity and neuroplasticity.
|
baseline (Day 1), post-intervention (Day 12), 3 month follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Bernadette Gillick, PhD, MSPT, UW School of Medicine and Public Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. juni 2027
Datoer for studieregistrering
Først innsendt
27. juli 2026
Først innsendt som oppfylte QC-kriteriene
27. juli 2026
Først lagt ut (Faktiske)
31. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. september 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske prosesser
- Blødning
- Hjerneiskemi
- Tegn og symptomer, luftveier
- Hypoksi, hjerne
- Hypoksi
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hypoksi-iskemi, hjerne
- Intrakranielle blødninger
- Terapeutikk
- Fysioterapi -modaliteter
- Treningsterapi
- Rehabilitering
- Constraint Induced Movement Therapy
Andre studie-ID-numre
- 2026-0790
- ICTR Pilot Award (Annet stipend/finansieringsnummer: NCATS)
- Protocol Version 6/17/26 (Annen identifikator: UW Madison)
- SMPH/Pediatrics/Dev & Reh Med (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .