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Recruiting NCT07063446

sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

No phase Interventional Hemiplegia Perinatal Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sTMS, taVNS.
Who it may be relevant to
Registry conditions: Hemiplegia, Perinatal Brain Injury. Basic parameters: 8 months — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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 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.

Interventions

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

Primary outcome measures

  • Assisted Hand Assessment [Time frame: 3months]
  • Motor Evoked Potential (MEP) [Time frame: 3 months]
Secondary outcome measures (1)
  • GMFM-88 [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Publications

  • Sutter EN, Casey CP, Gillick BT. Single-pulse transcranial magnetic stimulation for assessment of motor development in infants with early brain injury. Expert Rev Med Devices. 2024 Mar;21(3):179-186. doi: 10.1080/17434440.2023.2299310. Epub 2024 Jan 3. PMID 38166497
  • Casey CP, Sutter EN, Grimaldo A, Collins KM, Guerrero-Gonzalez J, McAdams RM, Dean DC 3rd, Gillick BT. Preservation of Bilateral Corticospinal Projections from Injured Hemisphere After Perinatal Stroke. Brain Sci. 2025 Jan 17;15(1):82. doi: 10.3390/brainsci15010082. PMID 39851449
  • McGloon K, Humanitzki E, Brennan J, Summers P, Brennan A, George MS, Badran BW, Cribb AR, Jenkins D, Coker-Bolt P. Pairing taVNS and CIMT is feasible and may improve upper extremity function in infants. Front Pediatr. 2024 Feb 13;12:1365767. doi: 10.3389/fped.2024.1365767. eCollection 2024. PMID 38415207

Identifiers

NCT: NCT07063446 · Pro00146198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗