CIMT and taVNS for Hemiplegia in Infants

NCT05101707 | Completed Early Phase 1 Results FDA Device

• 2 other identifiers: 109558P2CHD086844
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.

Conditions

Infant Development; Hemiplegia; Constraint Induced Movement Therapy

Keywords

transcutaneous auricular vagus nerve stimulation; constraint induced movement therapy; infant hemiplegia

Outcome Measures

Primary Outcomes (2)

• CIMT Fidelity

  Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure

  at 1 month

• Quality of Upper Extremity Skills Test (QUEST), GRASP

  change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment

  1 month

Secondary Outcomes (1)

• Gross Motor Function Measure-88 (GMFM-88)

  1 month

Study Arms (1)

CIMT + taVNS

EXPERIMENTAL

The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia

Device: transcutaneous auricular vagus nerve stimulation; Other: Constraint induced movement therapy

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

Applying a pulsed microcurrent to the auricular branch of the vagus nerve, timed with motor activity of the weaker arm/hand

Also known as: taVNS

CIMT + taVNS

Constraint induced movement therapy OTHER

Applying a custom-made splint constraint to the stronger hand/arm to encourage use of the weaker hand/arm in intensive therapy sessions

Also known as: CIMT

CIMT + taVNS

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Must have all of the following:
• month-old infants with hemiplegia/motor asymmetry
• Must be able to participate in high intensity CIMT
• Gross Motor Function Classification System (GMFCS) level I-IV

You may not qualify if:

• Must have none of the following:
• GMFCS level V
• severe motor impairment/quadriplegic involvement
• uncorrected blindness or deafness
• cardiomyopathy

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center of Neuromodulation for Rehabilitation: collaborator
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Dr Dorothea Jenkins
• Organization: Medical University of South Carolina

jenkd@musc.edu

(843)792-2112

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CIMT plus taVNS

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 1, 2021
• Study Start: April 1, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)