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Behavioural Intervention

Nerve Stimulation + Hand Therapy for Cerebral Palsy

Q: What qualifications are necessary to become an enrollee in this experiment?

Eligibility criteria for this clinical trial necessitate that participants have <a href="https://www.withpower.com/clinical-trials/cerebral-palsy">cerebral palsy</a> and are between 6 Months to 18 Months old. The study requires a maximum of 5 enrollees.

Q: Does this research endeavor accept participants aged 55 or over?

This clinical study has a 6 month lower limit and 18 month upper age restriction for inclusion.

Q: How many participants are taking part in this research experiment?

Affirmative. According to information available on clinicaltrials.gov, this research endeavour is actively recruiting patients with enrolment beginning April 17th 2023 and the most recent update posted June 23rd 2023. 5 individuals are sought from a single site for participation in this study.

Q: Are there remaining vacancies available to participants of this research study?

The trial, which was first published on April 17th 2023, is currently recruiting participants. This information has been confirmed on clinicaltrials.gov and the details of this medical study were last revised on June 23rd 2023.

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

Awards & highlights

Study Summary

This trial will study if combining nerve stimulation with intensive hand therapy can help infants & children with one-sided weakness improve their motor skills.

Who is the study for?

This trial is for infants aged 6-18 months with cerebral palsy who have difficulty using one side of their body but can sit with some help. It's not suitable for those with the most severe motor impairments, uncorrected blindness or deafness, or heart muscle disease.Check my eligibility

What is being tested?

The study tests a new therapy combining nerve stimulation by the ear (taVNS) triggered by muscle activity sensors, alongside constraint-induced movement therapy (CIMT), to improve motor skills in infants with one-sided weakness.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site near the ear and possible skin irritation from wearing EMG sensors. Since it's non-invasive, serious risks are expected to be low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of 4 week treatment intervention (40 hours of cimt)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of 4 week treatment intervention (40 hours of cimt)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of 4 week treatment intervention (40 hours of cimt) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Device Feasibility

Treatment fidelity

Secondary outcome measures

Change in motor function

Trial Design

1Treatment groups

Experimental Treatment

Group I: Soterix taVNS stimulation using EMG sensorsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy

2023

Completed Early Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,631 Total Patients Enrolled

2 Trials studying Cerebral Palsy

29 Patients Enrolled for Cerebral Palsy

Media Library

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05857527 — Phase < 1

Cerebral Palsy Research Study Groups: Soterix taVNS stimulation using EMG sensors

Cerebral Palsy Clinical Trial 2023: Custom EMG triggered Soterix taVNS stimulation with CIMT therapy Highlights & Side Effects. Trial Name: NCT05857527 — Phase < 1

Custom EMG triggered Soterix taVNS stimulation with CIMT therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857527 — Phase < 1

Frequently Asked Questions

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

What qualifications are necessary to become an enrollee in this experiment?

"Eligibility criteria for this clinical trial necessitate that participants have cerebral palsy and are between 6 Months to 18 Months old. The study requires a maximum of 5 enrollees."

Answered by AI

Does this research endeavor accept participants aged 55 or over?

"This clinical study has a 6 month lower limit and 18 month upper age restriction for inclusion."

Answered by AI

How many participants are taking part in this research experiment?

"Affirmative. According to information available on clinicaltrials.gov, this research endeavour is actively recruiting patients with enrolment beginning April 17th 2023 and the most recent update posted June 23rd 2023. 5 individuals are sought from a single site for participation in this study."

Answered by AI

Are there remaining vacancies available to participants of this research study?

"The trial, which was first published on April 17th 2023, is currently recruiting participants. This information has been confirmed on clinicaltrials.gov and the details of this medical study were last revised on June 23rd 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kelly Mcgloon 2023. "Extending taVNS Paired With Infant CIMT Into a Home-Based Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05857527.