sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia
Medical University of South Carolina
10 participants
Nov 7, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Infants 8-24mo with hemiplegia or asymmetric weakness of one arm, with or without truncal and transitional motor delays
- Gross Motor function Classification system (GMFCS) I - IV
- Parents are able to make consecutive appointments for assessments and intervention over 2wks and complete the 3mo follow-up.
- Parents are willing to fill out developmental questionnaires and provide the study team feedback on tolerability and outcomes.
Exclusion Criteria4
- previous CIMT within 3 months
- GMFCS V or severe motor impairment/quadriplegia
- uncorrected blindness/deafness, cardiomyopathy
- poorly controlled seizure disorder
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Interventions
Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials
taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07063446