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

NCT05857527 | Completed Early Phase 1 Results DMC FDA Device

• 1 other identifier: Pro00123579
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Device Feasibility

  Feasibility is measured as percent of total treatment time Electromyography (EMG) can successfully trigger stimulation during a Constraint induced movement therapy (CIMT) rehabilitation session.

  end of 4 week treatment intervention (40 hours of CIMT)

Secondary Outcomes (2)

• Fidelity of Implementation Measure (FIRM)

  end of 4 week treatment intervention (40 hours of CIMT)

• Quality of Upper Extremity Skills Test (QUEST)

  Change in functional motor outcome completed pre and post 40 hours of treatment

Study Arms (2)

EMG triggering feasibility

EXPERIMENTAL

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.

Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab

taVNS and EMG feasibility at home

EXPERIMENTAL

For the 2nd phase of the study we will trial using the EMG triggered system to deliver taVNS and CIMT in the home setting.

Combination Product: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home

Interventions

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab COMBINATION_PRODUCT

Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 1 will occur in the lab, and ongoing notifications will be made to the EMG system to test feasibility of automatic stimulation

EMG triggering feasibility

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home COMBINATION_PRODUCT

Participants will receive taVNS stimulation paired with 40 hours of constraint-induced movement therapy. The new device will automatically trigger stimulation using EMG muscle sensors worn during the therapy session. Phase 2 will occur in the home and will assess the quality of the CIMT therapy provided with the automated EMG system.

taVNS and EMG feasibility at home

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• GMFCS level V
• Severe motor impairment/ quadriplegic involvement
• Uncorrected blindness or deafness
• Cardiomyopathy

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Laboratories; Home Care Services

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services; Community Health Services; Health Services; Nursing Services

Limitations and Caveats

The purpose of this trial was to test the feasibility of using EMG to trigger taVNS stimulation. The EMG sensors did not stay in place well for some infants. Additionally, there was a large amount of time and effort required for individual calibration. We met the goal threshold of phase 1 for our EMG sensor to trigger taVNS stimulation. However, the automatic triggering did not continue to work well for subsequent participants.

Results Point of Contact

• Title: Kelly McGloon
• Organization: Medical University of South Carolina

mcgloon@musc.edu

8437926443

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For this study we are making modifications to the taVNS stimulation (Soterix unit) system. These modifications include using Electromyography (EMG) muscle sensors to trigger stimulation instead of a manual button. We are also transitioning the manual stimulation option to Bluetooth to improve ease of use in the clinic with infants. The taVNS stimulation will be paired with constraint induced movement therapy (CIMT) an established rehabilitation intervention. The Soterix taVNS unit is FDA registered and is a custom version of an FDA cleared device. The first 2 participants will complete phase 1 of the study. In this phase we will make adjustments to the EMG system and physical set up with the goal of having the EMG sensors trigger taVNS stimulation with 75% of total time for active arma and trunk movements during CIMT. In phase 2 we will use the EMG triggered taVNS setup to deliver CIMT in home.

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: May 12, 2023
• Study Start: April 17, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)