sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
Recruiting
N/AInterventional Study
HemiplegiaPerinatal Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
8 Months – 24 Months
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
10 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for infants aged 8 to 24 months who have weakness in one arm due to brain injury. Participants will receive a new treatment that combines brain stimulation and therapy to help improve their movement abilities.
Are You a Good Fit for This Trial?
You may be able to join if
I am 8 to 24 months old.
I have hemiplegia or weakness in one arm.
I may have delays in movement.
I can attend appointments over 2 weeks.
I can complete a 3-month follow-up.
I am willing to fill out questionnaires about my progress.
You may not be able to join if
I have had CIMT in the last 3 months.
I have severe motor impairment or quadriplegia.
I have uncorrected blindness or deafness.
I have a poorly controlled seizure disorder.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 move…
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.
Trial Locations
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Eligibility Criteria
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 an…
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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