Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05857527 |
| Other study ID # |
Pro00123579 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
April 17, 2023 |
| Est. completion date |
March 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Medical University of South Carolina |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Preterm birth and complications in term births can result in increased risk for
intraventricular hemorrhage, global hypoxia-ischemia (HIE), arterial stoke, and
neuroinflammation with white matter injury in newborns. CNS injuries then may manifest as
early developmental delays and motor weakness in the first 12 months, that presage hemiplegic
cerebral palsy (CP).
Early targeted therapy interventions for high-risk infants aim to improve neurological
outcomes by taking advantage of critical windows for neuroplasticity. Intensive
interventions, such as constraint-induced movement therapy (CIMT), are designed to ameliorate
early motor predecessors of CP in at-risk infants. This intervention must be provided at a
minimally effective dosage of 40 hours, and 60-120 hours for optimal outcomes, and are
typically provided in a condensed time period, over 4 to 6 weeks with intensive task-practice
for 3-6 hours a day. Delivering CIMT within the context a typical family day is a challenge.
Interventional strategies that reduce the time requirement while offering the same or better
outcomes would benefit families and facilitate treatment delivery.
Few studies have used neuromodulation combined with intensive motor therapies, such as CIMT,
to enhance neuroplasticity and improve functional outcomes in children. Transcranial direct
current stimulation has been used safely in older children with CP during bimanual learning
therapy. Our group is 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 determined to
need a gastrostomy tube (G-tube) attained full oral feeds (mean time to full oral feeds 15
days with once daily, and 7.8 days with twice daily treatment). This study will use EMG
sensing of muscle activity to trigger the taVNS system. Use of EMG sensors is hypothesized to
improve pairing of stimulation with motor activity while also decreasing the treatment burden
for the therapist.
