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sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

ConditionsHemiplegiaPerinatal Brain Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-24
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

previous CIMT within 3 months

GMFCS V or severe motor impairment/quadriplegia

uncorrected blindness/deafness, cardiomyopathy

poorly controlled seizure disorder

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: sTMS with taVNS paired CIMTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Assisted Hand Assessment

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

Time frame
3months
2

Motor Evoked Potential (MEP)

Presence or absence (+ or -) of MEP in the affected upper extremity in response to sTMS of primary motor cortex in both hemispheres (circuit analysis)

Time frame
3 months

Secondary outcomes

1

GMFM-88

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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