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taVNS + CIMT for Infant Hemiplegia

Q: Are there currently any openings for participants in this research project?

Correct. According to information on clinicaltrials.gov, this medical experiment was first posted in April 1st 2022 and is actively recruiting patients as of August 11th 2022. The research requires 5 participants from a single location.

Q: Is it feasible to join this clinical experiment?

Candidates for this trial should have gone through mirror movements therapy, and be between 6 months to 18 months old. A total of 5 participants will be taken into the experiment.

Q: Does this study admit participants who are beyond 30 years of age?

This medical trial is available to infants between the ages of 6 and 18 months, in line with its pre-defined criteria.

Q: What is the current quota for participants in this research project?

Affirmative. According to clinicaltrials.gov, recruitment for this treatment trial is still ongoing; it was first announced on April 1st 2022 and the most recent update occurred August 11th of that same year. The study aims to enrol 5 individuals from a single medical site.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-2 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,964 Previous Clinical Trials

2,674,727 Total Patients Enrolled

7 Trials studying Hemiplegia

509 Patients Enrolled for Hemiplegia

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,536 Total Patients Enrolled

4 Trials studying Hemiplegia

231 Patients Enrolled for Hemiplegia

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,387 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for participants in this research project?

"Correct. According to information on clinicaltrials.gov, this medical experiment was first posted in April 1st 2022 and is actively recruiting patients as of August 11th 2022. The research requires 5 participants from a single location."

Answered by AI

Is it feasible to join this clinical experiment?

"Candidates for this trial should have gone through mirror movements therapy, and be between 6 months to 18 months old. A total of 5 participants will be taken into the experiment."

Answered by AI

Does this study admit participants who are beyond 30 years of age?

"This medical trial is available to infants between the ages of 6 and 18 months, in line with its pre-defined criteria."

Answered by AI

What is the current quota for participants in this research project?

"Affirmative. According to clinicaltrials.gov, recruitment for this treatment trial is still ongoing; it was first announced on April 1st 2022 and the most recent update occurred August 11th of that same year. The study aims to enrol 5 individuals from a single medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CIMT and taVNS for Hemiplegia in Infants

Dorothea D. Jenkins 2022. "CIMT and taVNS for Hemiplegia in Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101707.