NCT05101707

CIMT and taVNS for Hemiplegia in Infants

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2021-11-01
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study