sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-24
SponsorMedical University of South Carolina
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
previous CIMT within 3 months
GMFCS V or severe motor impairment/quadriplegia
uncorrected blindness/deafness, cardiomyopathy
poorly controlled seizure disorder
Trial design
Treatments tested in this trial
- sTMS
- taVNS
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov