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sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

RecruitingNAAges 8 Months - 24 MonthsAllMedical University of South Carolina
NCT07063446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * previous CIMT within 3 months * GMFCS V or severe motor impairment/quadriplegia * uncorrected blindness/deafness, cardiomyopathy * poorly controlled seizure disorder
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What it tests

  • sTMS
  • taVNS
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Where

1 site
Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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