sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hemiplegia Perinatal Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The trial is designed to use a diagnostic device prior to using an experimental treatment device paired with non-experimental physical therapy (CIMT).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sTMS with taVNS paired CIMT

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

Group Type EXPERIMENTAL

sTMS

Intervention Type DEVICE

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

taVNS

Intervention Type 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

Interventions

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sTMS

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

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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

Minimum Eligible Age

8 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No