Early Phase 1
Completed N=4
Extending taVNS Paired With Infant CIMT Into a Home-Based Setting
Source: ClinicalTrials.gov NCT05857527 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcomePrimary: Device Feasibility — 33.33 percent time EMG taVNS stimulation
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.
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 | — |
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
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. Informational only — not medical advice.