CIMT and taVNS for Hemiplegia in Infants

Early Phase 1

Completed

• Conditions: Hemiplegia; Constraint Induced Movement Therapy; Infant Development
• Interventions: Device: transcutaneous auricular vagus nerve stimulation; Other: Constraint induced movement therapy

• Registration Number: NCT05101707
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Study Start: 2022-04-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIMT + taVNS	transcutaneous auricular vagus nerve stimulation	The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia
CIMT + taVNS	Constraint induced movement therapy	The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia

Primary Outcome Measures

Name	Time	Method
CIMT fidelity	0-1 month	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
Quality of Upper Extremity Skills Test (QUEST)	0-2 months	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

Secondary Outcome Measures

Name	Time	Method
Gross Motor Function Measure-66 (GMFM-66)	0-2 months	Gross Motor Function Measure-66 scores range from 0-3, with higher scores indicating better foundational gross motor skills and greater mastery of a task
Goal Attainment Scale (GAS)	0-2 months	Goal Attainment Scale is an individualized standardized outcome measure that calculates the extent to which a patient's individual therapy goals are met, scored from -2 to +2 with higher scores indicating better than expected outcome, -2 indicating worse than expected outcome
Developmental Assessment of Young Children (DAYC) Physical Development domain	0-2 months	Developmental Assessment of Young Children, 2nd edition, physical domain is a standardized assessment of fine and gross motor skills, with a mean of 100 +/- 15

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States