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Study of sTMS, CIMT, and taVNS for Infants with Hemiplegia

This study is looking at new ways to help infants aged 8 to 24 months who have hemiplegia (weakness on one side of the body) or uneven arm weakness due to a brain injury around birth. It combines sTMS (single pulse transcranial magnetic stimulation), taVNS (transcutaneous auricular vagus nerve stimulation), and CIMT (constraint-induced movement therapy). CIMT involves encouraging the use of the weaker arm while the stronger arm is gently restricted. Researchers want to see if taVNS, when paired with 40 hours of CIMT, can improve arm and hand function. They will also use sTMS to measure how well the brain is connected to the hand, which might help predict who benefits most from the treatment. The study aims to enroll 10 infants.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would need to attend consecutive appointments for assessments and intervention over two weeks. There will also be a follow-up assessment at 3 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up for 3 months after the intervention, with assessments of hand function and motor evoked potentials.

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NCT07063446

sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Recruiting
NAAges 8–24InterventionalTreatment
Medical University of South Carolina
~10 participants
Updated 2025-11-26 on ClinicalTrials.gov
What's tested:sTMStaVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assisted Hand Assessment
Measured over 3months
+1 more outcome measured

Conditions

Hemiplegia
Perinatal Brain Injury

Explore related trials

HemiplegiaPerinatal Brain Injury

Where it's being run

1 sites across 1 states
South Carolina1

Who to contact

Dorothea Jenkins, MD
[email protected]
843-792-2112
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

previous CIMT within 3 months
GMFCS V or severe motor impairment/quadriplegia
uncorrected blindness/deafness, cardiomyopathy
poorly controlled seizure disorder

What this trial measures

  • Assisted Hand Assessment3months

    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

  • Motor Evoked Potential (MEP)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)