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NCT Number: NCT07063446

sTMS Combined With CIMT and taVNS 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.

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Key information

Age range

8 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Cynthia Dodds, PhD PT

SUB_INVESTIGATOR

Dorothea Jenkins, MD

CONTACT

[email protected]

843-792-2112

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sTMS

Device

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

taVNS

Device

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

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia Dodds, PT PhD

CONTACT

[email protected]

843- 792-5731

Dorothea Jenkins, MD

CONTACT

[email protected]

843-792-2112

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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