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

Early Phase 1

Completed

• Conditions: Cerebral Palsy
• Interventions: Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy

• Registration Number: NCT05857527
• Lead Sponsor: Medical University of South Carolina

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-23
• Study Start: 2023-04-17
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-12
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soterix taVNS stimulation using EMG sensors	Custom EMG triggered Soterix taVNS stimulation with CIMT therapy	We will trial use of a new taVNS unit that uses automated EMG sensors to trigger stimulation and an optional Bluetooth manual trigger. This experimental device will be used to during CIMT rehabilitation treatment to pair stimulation with active movement.

Primary Outcome Measures

Name	Time	Method
Treatment fidelity	end of 4 week treatment intervention (40 hours of CIMT)	Fidelity Rating of Quality of Constraint Induced Movement Therapy Delivery while using the experimental EMG triggered Soterix taVNS stimulator.
Device Feasibility	end of 4 week treatment intervention (40 hours of CIMT)	Feasibility is measured as percent of total treatment time EMG can successfully trigger stimulation during a CIMT rehabilitation session.

Secondary Outcome Measures

Name	Time	Method
Change in motor function	Change in functional motor outcome completed pre and post 40 hours of treatment	Assessment of change in functional motor outcomes pre and post intervention on the Quality of Upper Extremity Skills Test (QUEST)

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States