CIMT and taVNS for Hemiplegia in Infants

NCT ID: NCT05101707

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-02-29

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.

Conditions

Infant Development; Hemiplegia; Constraint Induced Movement Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

CIMT + taVNS

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

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

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

Constraint induced movement therapy

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

Other Intervention Names

taVNS; CIMT

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Neuromodulation for Rehabilitation

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P2CHD086844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

109558

Identifier Type: -

Identifier Source: org_study_id