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sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

NCT07063446 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

  • Hemiplegia
  • Perinatal Brain Injury

Interventions

DEVICE

sTMS

Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials

DEVICE

taVNS

taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07063446 on ClinicalTrials.gov