sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

November 20, 2025 updated by: Dorothea Jenkins, Medical University of South Carolina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the most effective early therapies for improving motor skills in infants with unilateral motor weakness after perinatal brain injury, is constraint induced movement therapy (CIMT), in which a therapist engages a child in targeted play therapy with the more-affected arm/hand while the less-affected arm is immobilized in a mitt, reinforcing activity-dependent neuroplasticity. taVNS may accelerate functional gains and boost CIMT effects in young infants with hemiplegia over CIMT alone, based on pilot data. Before embarking on a larger scale trial, single pulse transcranial magnetic stimulation (sTMS) will be used to determine the connectivity and strength of the cortical spinal tract motor circuit with motor evoked potential of the hand or thumb.

The hypothesis is that the ability to respond to taVNS paired with intensive motor skill therapy in hemiplegic infants may be predicted by motor evoked potentials (MEP) elicited from sTMS over the motor cortex, as a quantifiable biomarker of CST circuit integrity, circuit response and cortical excitability.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dorothea Jenkins, MD
  • Phone Number: 843-792-2112
  • Email: jenkd@mus.edu

Study Contact Backup

  • Name: Cynthia Dodds, PT PhD
  • Phone Number: 843- 792-5731
  • Email: doddscb@musc.edu

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Sub-Investigator:
          • Cynthia Dodds, PhD PT
        • Contact:
          • Dorothea Jenkins, MD
          • Phone Number: 843-792-2112
          • Email: jenkd@msuc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sTMS with taVNS paired CIMT
sTMS diagnostic testing will be performed before and after 40hours of taVNS paired with CIMT treatment
Device: sTMS
Single pulses of TMS will be delivered over the motor cortex to quantify and map the motor evoked potentials
Device: 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
Other Names:
  • transcutaneous auricular vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assisted Hand Assessment
Time Frame: 3months
Percent Change in the mini-AHA or AHA from baseline to end of treatment- the standardized scale on the Assisted hand assessments range from 0-100 where 100 indicates greatest possible functional use of the hand and 0 indicates no hand function
3months
Motor Evoked Potential (MEP)
Time Frame: 3 months
Presence or absence (+ or -) of MEP in the affected upper extremity in response to sTMS of primary motor cortex in both hemispheres (circuit analysis)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMFM-88
Time Frame: 3 months
Percent Change in scores of Gross motor function measure-88 from baseline to end of treatment; total raw scores range from 0-264, with higher scores indicating greater motor function
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

South Carolina Clinical & Translational Research Institute (SCTR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

July 3, 2025

First Posted (Actual)

July 14, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00146198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Videotapes of motor skills assessments are identifiable PHI and will not be shared. Extracted, de-identifed data may be shared on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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