Early Phase 1 N=4 Device Feasibility

Extending taVNS Paired With Infant CIMT Into a Home-Based Setting

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT05857527 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Device Feasibility — 33.33 percent time EMG taVNS stimulation

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab (Combination_product); Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home (Combination_product)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Device Feasibility	33.33	—
SECONDARY Fidelity of Implementation Measure (FIRM)	—	—
SECONDARY Quality of Upper Extremity Skills Test (QUEST)	14.8; 24.89	—

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. taVNS stimulation will be triggered by EMG sensors which detect muscle activity. 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 6-18 months of age.

Eligibility Criteria

Inclusion Criteria

Five 6-18-month-old infants
Hemiplegia/motor asymmetry qualifying for Constraint Induced Movement Therapy
Gross Motor Function Classification System (GMFCS) level I-IV
Ability to maintain a sitting position for 5 minutes with moderate assistance

Exclusion Criteria

GMFCS level V
Severe motor impairment/ quadriplegic involvement
Uncorrected blindness or deafness
Cardiomyopathy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05857527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.