Clinical trial NCT05101707: CIMT and taVNS for Hemiplegia in Infants
Official title: Combining taVNS With Early CIMT to Improve Health Outcomes of Infants With Unilateral Upper Extremity Weakness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infant Development
Hemiplegia
Constraint Induced Movement Therapy
Keywords: transcutaneous auricular vagus nerve stimulation
constraint induced movement therapy
infant hemiplegia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Center of Neuromodulation for Rehabilitation
name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-01
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CIMT plus taVNS
Primary purpose: DEVICE_FEASIBILITY

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. 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.

Detailed description: Recent pioneering studies have used neuromodulation combined with intensive motor therapies in adults after stroke. Few studies have investigated combining neuromodulation and evidence-based pediatric intensive therapies such as CIMT, and then only in older children with CP to enhance neuroplasticity and improve functional outcomes. The investigators are 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 attained full oral feeds who were slated to receive a gastrostomy tube (G-tube). With the unique collaboration of experts in brain stimulation, pediatric translational clinical science and pediatric occupational therapy in this pilot project, the investigators propose to expand the paradigm of pairing neuromodulation with motor training in at-risk infants by exploring the safety, feasibility, and effectiveness of delivering taVNS concurrently with CIMT. The hypothesis is that combining taVNS with intensive CIMT may boost neuroplasticity, allowing for delivery of infant therapy at a minimally effective dosage while improving infant outcomes.

The investigators aim to determine the feasibility and safety of taVNS in at-risk infants 6-18mo undergoing CIMT therapy in open label pilot trial and assess both infant tolerability and the therapist's ability to deliver high-quality CIMT along with taVNS.

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

Primary outcomes:
measure: CIMT Fidelity
timeFrame: at 1 month
measure: Quality of Upper Extremity Skills Test (QUEST), GRASP
timeFrame: 1 month
Secondary outcomes:
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: 1 month
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: