CIMT and taVNS for Hemiplegia in Infants

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Constraint Induced Movement Therapy; Hemiplegia; Infant Development

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05101707

P2CHD086844 (U.S. NIH Grant/Contract)

109558

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 6 to 18 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

CIMT + taVNS

Experimental group

Description:

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

Treatment:

Other: Constraint induced movement therapy

Device: transcutaneous auricular vagus nerve stimulation