Actively Recruiting
sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
Led by Medical University of South Carolina · Updated on 2025-11-26
10
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
sTMS Combined With CIMT and taVNS In Infants With Hemiplegia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants aged 8 to 24 months with hemiplegia or one-sided arm weakness, with or without trunk and transitional motor delays
- Gross Motor Function Classification System (GMFCS) levels I to IV
- Parents able to attend consecutive appointments for assessments and intervention over 2 weeks and complete a 3-month follow-up
- Parents willing to complete developmental questionnaires and provide feedback on tolerability and outcomes
You will not qualify if you...
- Previous constraint induced movement therapy within 3 months
- GMFCS level V or severe motor impairment/quadriplegia
- Uncorrected blindness or deafness
- Cardiomyopathy (heart muscle disease)
- Poorly controlled seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
D
Dorothea Jenkins, MD
CONTACT
C
Cynthia Dodds, PT PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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