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

Early Phase 1

Completed

Conditions: Cerebral Palsy

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. Centeral Nervous System (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4

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: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Device Feasibility	end of 4 week treatment intervention (40 hours of CIMT)	Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.

Secondary Outcome Measures

Name	Time	Method
Quality of Upper Extremity Skills Test (QUEST)	Change in functional motor outcome completed pre and post 40 hours of treatment	Quality of Upper Extremity Skills Test The QUEST is a criterion-referenced measure designed to evaluate the quality of upper extremity function in young children with spasticity. We calculated scores from 2 domains:1) Dissociated movement and2) Grasp Item scores are summed; formulas are used to calculate percentages for each domain. Domain percentages are summed and divided by number of domains (2 for our study) to obtain total score. Minimum score = 0; Maximum score = 100 The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.
Fidelity of Implementation Measure (FIRM)	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. Fidelity of Implementation Measure (FIRM) which describes how consistently therapists exhibit behaviors consistent with CIMT principles and operant conditioning techniques and are rated on a scale of 1-4. A 4 being consistently demonstrating with less than 1 exception, and 1 being rarely or not at all. A score of 3 indicates acceptable to high fidelity.

Trial Locations

Locations (1): Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States