sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

NCT07063446 | Recruiting DMC FDA Device

• 1 other identifier: Pro00146198
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia; Perinatal Brain Injury

Keywords

constraint induced movement therapy; infants; taVNS; sTMS; hemiplegia

Outcome Measures

Primary Outcomes (2)

• 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

  3months

• 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)

  3 months

Secondary Outcomes (1)

• GMFM-88

  3 months

Study Arms (1)

sTMS with taVNS paired CIMT

EXPERIMENTAL

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

Device: sTMS; Device: taVNS

Interventions

sTMS DEVICE

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

sTMS with taVNS paired CIMT

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

Also known as: transcutaneous auricular vagus nerve stimulation

sTMS with taVNS paired CIMT

Eligibility Criteria

• Age: 8 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dorothea Jenkins, MD

CONTACT

843-792-2112; jenkd@mus.edu

Cynthia Dodds, PT PhD

CONTACT

843- 792-5731; doddscb@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

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

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)