sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07063446
Status
Recruiting
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Conditions

  • Hemiplegia
  • Perinatal Brain Injury

Eligibility Criteria

Sex
ALL
Age
8 Months - 24 Months
Healthy Volunteers
Not accepted

Interventions

  • sTMS — DEVICE
    Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials
  • taVNS — DEVICE
    taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT

Study Details

Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.

Key Dates

Start date
Nov 7, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: sTMS with taVNS paired CIMT
    sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment

Primary Outcome Measure

Assisted Hand Assessment [ Time Frame: 3months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Dorothea Jenkins, MD
[email protected]
843-792-2112
Cynthia Dodds, PhD PT (SUB_INVESTIGATOR)

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By research site
Medical University of South Carolina· Charleston, SC

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