sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Medical University of South Carolina (MUSC)

Status and phase

Begins enrollment this month

Early Phase 1

Conditions

Perinatal Brain Injury

Hemiplegia

Treatments

Device: sTMS

Device: taVNS

Study type

Interventional

Funder types

Other

Identifiers

NCT07063446

Pro00146198

Details and patient eligibility

About

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.

Full 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 our pilot data. Before embarking on a larger scale trial, we will use single pulse transcranial magnetic stimulation (sTMS) to determine the connectivity and strength of the cortical spinal tract motor circuit with motor evoked potential of the hand or thumb.

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

Enrollment

10 estimated patients

Sex

All

Ages

8 to 24 months old

Volunteers

No Healthy Volunteers

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