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CIMT and taVNS for Hemiplegia in Infants
EARLY_PHASE1 trial testing transcutaneous auricular vagus nerve stimulation in Infant Development in 6 participants. Completed in 29 February 2024.
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 6 |
| Start date | 1 April 2022 |
| Primary completion | 29 February 2024 |
| Estimated completion | 29 February 2024 |
| Sites | 1 location across United States |
Medical University of South Carolina
Adults 6 Months to 18 Months, any sex, with Infant Development or Hemiplegia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility of delivering high fidelity CIMT therapy sessions while the therapist is also triggering taVNS using the Fidelity of Implementation Measure (FIRM) with scoring range (0-4), higher scores indicate greater consistency of therapy with established CIMT procedure
| Group | Value | 95% CI |
|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | 3.76 | 3.58 – 3.76 |
change in test of hand function and quality of movement between the right and left sides of the body, scoring range 0-100, higher scores indicate better hand function; from baseline to end of treatment
| Group | Value | 95% CI |
|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | 209 | ± 161 |
The Gross Motor Function Measure-88 (GMFM-88) assessment tool includes 88 items, each receiving a score from 0 to 3 (0 = does not initiate; 1 = initiates; 2 = partially completes; 3 = completes). Items span the spectrum of gross motor activities in five dimensions: A: Lying and Rolling (17 items), B: Sitting (20 items), C: Crawling and Kneeling (14 items), D: Standing (13 items), E: Walking, Running, Jumping (24 items). Every dimension score is expressed with a percentage. All dimension scores are then averaged to a total GMFM-88 percentage score, which is an estimate of the participant's gros
| Group | Value | 95% CI |
|---|---|---|
| Open Label taVNS Paired With 40 Hours CIMT | 32 | ± 28 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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