CIMT and taVNS for Hemiplegia in Infants

Combining taVNS With Early CIMT to Improve Health Outcomes of Infants With Unilateral Upper Extremity Weakness

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Infant Development; Constraint Induced Movement Therapy
• Intervention / Treatment: Device: transcutaneous auricular vagus nerve stimulation; Other: Constraint induced movement therapy

Detailed Description

Recent pioneering studies have used neuromodulation combined with intensive motor therapies in adults after stroke. Few studies have investigated combining neuromodulation and evidence-based pediatric intensive therapies such as CIMT, and then only in older children with CP to enhance neuroplasticity and improve functional outcomes. The investigators are the first to use non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) paired with a motor task of bottle-feeding in infants with feeding failure. taVNS paired with motor feeding activity was safe and over 50% infants attained full oral feeds who were slated to receive a gastrostomy tube (G-tube). With the unique collaboration of experts in brain stimulation, pediatric translational clinical science and pediatric occupational therapy in this pilot project, the investigators propose to expand the paradigm of pairing neuromodulation with motor training in at-risk infants by exploring the safety, feasibility, and effectiveness of delivering taVNS concurrently with CIMT. The hypothesis is that combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage while improving infant outcomes.

The investigators aim to determine the feasibility and safety of taVNS in at-risk infants 6-18mo undergoing CIMT therapy in open label pilot trial and assess both infant tolerability and the therapist's ability to deliver high-quality CIMT along with taVNS.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Must have all of the following:

• 6-18 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

Exclusion Criteria:

Must have none of the following:

• GMFCS level V
• severe motor impairment/quadriplegic involvement
• uncorrected blindness or deafness
• cardiomyopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CIMT + taVNS; The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia

Device: transcutaneous auricular vagus nerve stimulation; Applying a pulsed microcurrent to the auricular branch of the vagus nerve, timed with motor activity of the weaker arm/hand; Other Names: taVNS; Other: Constraint induced movement therapy; Applying a custom-made splint constraint to the stronger hand/arm to encourage use of the weaker hand/arm in intensive therapy sessions; Other Names: CIMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure-88 (GMFM-88)	The Gross Motor Function Measure-88 (GMFM-88) assessment tool includes 88 items, each receiving a score from 0 to 3 (0 = does not initiate; 1 = initiates; 2 = partially completes; 3 = completes). Items span the spectrum of gross motor activities in five dimensions: A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), E: Walking, Running, Jumping (24 items). Every dimension score is expressed with a percentage. All dimension scores are then averaged to a total GMFM-88 percentage score, which is an estimate of the participant's gross motor function (0 = low motor function; 100 = high motor function).	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: transcutaneous auricular vagus nerve stimulation; constraint induced movement therapy; infant hemiplegia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Paralysis; Hemiplegia
• Other Study ID Numbers: 109558; P2CHD086844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes