Integrating Corticospinal Tract Assessment Via sTMS And taVNS-Augmented CIMT In Infants With Hemiplegia

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 2
Healthy Volunteers: f
View:

• 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.

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Dorothea Jenkins, MD
jenkd@mus.edu
843-792-2112
Backup
Cynthia Dodds, PT PhD
doddscb@musc.edu
843- 792-5731
Time Frame
Start Date: 2025-11-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 10
Treatments
Experimental: sTMS with taVNS paired CIMT
sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment
Sponsors
Leads: Medical University of South Carolina

This content was sourced from clinicaltrials.gov