Early Phase 1
N=6
CIMT and taVNS for Hemiplegia in Infants
Infant Development · Hemiplegia · Constraint Induced Movement Therapy
Bottom Line
View on ClinicalTrials.gov: NCT05101707 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: CIMT Fidelity — 3.76 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- transcutaneous auricular vagus nerve stimulation (Device); Constraint induced movement therapy (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CIMT Fidelity |
3.76 | — |
| PRIMARY Quality of Upper Extremity Skills Test (QUEST), GRASP |
209 | — |
| SECONDARY Gross Motor Function Measure-88 (GMFM-88) |
32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05101707). 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.