Recruiting

taVNS & CIMT

Sponsor:

Medical University of South Carolina

Code:

NCT07063446

Conditions

Hemiplegia

Perinatal Brain Injury

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

sTMS

taVNS

Study Details

Brief 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.

Conditions

Hemiplegia

Perinatal Brain Injury

Study ID

NCT07063446

Start date

Nov 7, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: sTMS with taVNS paired CIMT

sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment

Interventions

sTMS

Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials

taVNS

taVNS will be used to stimulate the auricular branch of the vagus nerve and paired with CIMT for a total of 40hours of CIMT

Primary outcome measure

  • Assisted Hand Assessment [ Time Frame: 3months ]
  • Motor Evoked Potential (MEP) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Dorothea Jenkins, MD

843-792-2112jenkd@mus.edu

Cynthia Dodds, PT PhD

843- 792-5731doddscb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Dorothea Jenkins, MD

843-792-2112jenkd@msuc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • constraint induced movement therapy
  • infants
  • taVNS
  • sTMS
  • hemiplegia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-11-26.