MedTrace Logo

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

NCT05857527 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-07-04

Study results available
· View outcomes & findings →

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

Interventions

COMBINATION_PRODUCT

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in lab

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

COMBINATION_PRODUCT

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy in home

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.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2024-03-30
Completion
2024-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05857527 on ClinicalTrials.gov