sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jul 3, 2025

Keywords

ClinConnect Summary

This study is exploring a new way to help infants who have weakness on one side of their body, often caused by brain injury around the time of birth. This condition, called hemiplegia, can lead to delays in movement and may be an early sign of cerebral palsy. The trial is testing whether a gentle electrical stimulation called transcutaneous vagus nerve stimulation (taVNS), combined with a special therapy that encourages use of the weaker arm (called constraint-induced movement therapy or CIMT), can improve arm and hand movement in infants aged 8 to 24 months.

Families interested in this study should have a child with noticeable weakness on one side and be able to commit to several appointments over two weeks, plus a follow-up after three months. During the study, researchers will also use a quick brain test to see if a single pulse of brain stimulation can cause movement, which helps identify which babies might benefit most from the treatment. Parents will be asked to complete questionnaires and share their observations about how well the therapy is working and how comfortable their child feels during the process. This trial is not yet enrolling participants but aims to find better ways to support infants with early movement challenges.

Gender

ALL

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 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