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taVNS + CIMT for Infant Hemiplegia

Phase < 1
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-2 months
Awards & highlights

Study Summary

This trial is testing whether a non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), is safe and effective to improve motor skills when paired with constraint-induced movement therapy (CIMT) in infants with one-sided weakness.

Who is the study for?
This trial is for infants aged 6-18 months with hemiplegia or motor asymmetry who can handle high-intensity therapy and are classified as GMFCS level I-IV. Infants with severe motor impairment, quadriplegia (GMFCS level V), heart muscle disease, or uncorrected blindness or deafness cannot participate.Check my eligibility
What is being tested?
The study tests if combining transcutaneous auricular vagus nerve stimulation (taVNS)—a non-invasive ear nerve stimulation—with constraint-induced movement therapy (CIMT) helps improve motor skills in infants with one-sided weakness more effectively than CIMT alone.See study design
What are the potential side effects?
Potential side effects of taVNS may include discomfort at the stimulation site near the ear. Since CIMT involves restraint of the stronger arm to encourage use of the weaker side, it might cause frustration or skin irritation under the mitt.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CIMT fidelity
Quality of Upper Extremity Skills Test (QUEST)
Secondary outcome measures
Developmental Assessment of Young Children (DAYC) Physical Development domain
Goal Attainment Scale (GAS)
Gross Motor Function Measure-66 (GMFM-66)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CIMT + taVNSExperimental Treatment2 Interventions
The investigators will deliver taVNS paired with 40h of Constraint Induced Movement Therapy for unilateral weakness/hemiplegia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcutaneous auricular vagus nerve stimulation
2022
Completed Early Phase 1
~100

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,680,794 Total Patients Enrolled
7 Trials studying Hemiplegia
509 Patients Enrolled for Hemiplegia
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,224 Total Patients Enrolled
4 Trials studying Hemiplegia
231 Patients Enrolled for Hemiplegia
Medical University of South CarolinaLead Sponsor
940 Previous Clinical Trials
7,396,961 Total Patients Enrolled

Media Library

Constraint induced movement therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05101707 — Phase < 1
Hemiplegia Research Study Groups: CIMT + taVNS
Hemiplegia Clinical Trial 2023: Constraint induced movement therapy Highlights & Side Effects. Trial Name: NCT05101707 — Phase < 1
Constraint induced movement therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101707 — Phase < 1
~1 spots leftby Jun 2025
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