CIMT and taVNS for Hemiplegia in Infants

Hemiplegia Clinical Trial

Official title:

Combining taVNS With Early CIMT to Improve Health Outcomes of Infants With Unilateral Upper Extremity Weakness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05101707
• Other study ID #: 109558
• Secondary ID: P2CHD086844
• Status: Completed
• Phase: Early Phase 1
• Start date: April 1, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Constraint Induced Movement Therapy
• Hemiplegia
• Infant Development

Intervention

Device:
• transcutaneous auricular vagus nerve stimulation
Applying a pulsed microcurrent to the auricular branch of the vagus nerve, timed with motor activity of the weaker arm/hand

Other:
• Constraint induced movement therapy
Applying a custom-made splint constraint to the stronger hand/arm to encourage use of the weaker hand/arm in intensive therapy sessions

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center of Neuromodulation for Rehabilitation, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIMT fidelity	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	0-1 month
Primary	Quality of Upper Extremity Skills Test (QUEST)	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	0-2 months
Secondary	Developmental Assessment of Young Children (DAYC) Physical Development domain	Developmental Assessment of Young Children, 2nd edition, physical domain is a standardized assessment of fine and gross motor skills, with a mean of 100 +/- 15	0-2 months
Secondary	Goal Attainment Scale (GAS)	Goal Attainment Scale is an individualized standardized outcome measure that calculates the extent to which a patient's individual therapy goals are met, scored from -2 to +2 with higher scores indicating better than expected outcome, -2 indicating worse than expected outcome	0-2 months
Secondary	Gross Motor Function Measure-66 (GMFM-66)	Gross Motor Function Measure-66 scores range from 0-3, with higher scores indicating better foundational gross motor skills and greater mastery of a task	0-2 months