← Back to Search

Procedure

Treatment Group for Facial Palsy

N/A

Recruiting

Led By Patrick Byrne, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial aims to see if using a quick electrical stimulation during surgery can help improve nerve regrowth and smiling ability in patients undergoing facial reanimation surgery.

Who is the study for?

This trial is for individuals aged 18-80 with one-sided facial paralysis who are suitable candidates for a specific two-stage nerve graft surgery aimed at restoring their smile. Participants must agree to join the study. Those with paralysis on both sides of the face or other medical conditions that prevent this surgery cannot take part.Check my eligibility

What is being tested?

The study is testing whether a short session of electrical stimulation, called BES, during surgery can enhance nerve healing and improve smiling after undergoing cross-face nerve grafting procedures compared to standard surgical care without BES.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from electrical stimulation, typical surgical risks like infection or bleeding, and possible lack of improvement or differences in facial movement post-surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

To evaluate efficacy of an intraoperative dose of brief electrical stimulation (BES) to improve axonal regeneration across a cross-face nerve graft (CFNG) using nerve histology.

Secondary outcome measures

To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

Treatment group undergoes nerve biopsies during surgery. In addition, patients in the treatment group receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

Group II: Control GroupExperimental Treatment1 Intervention

Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BES

2017

N/A

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,365,538 Total Patients Enrolled

Patrick Byrne, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

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

Which individuals are eligible to participate in this clinical trial?

"Individuals aged between 18 and 80 years old with facial paralysis are eligible for enrollment in this clinical study, which aims to recruit approximately 20 participants."

Answered by AI

Are there any available slots for patients to participate in this research study?

"As per the information on clinicaltrials.gov, this research is actively seeking participants. The trial was first listed on March 1st, 2023, and most recently revised on March 21st, 2024."

Answered by AI

Is the clinical trial open to individuals younger than 70 years old?

"To be considered for participation in this research endeavor, individuals aged 18 to 80 are eligible. It is worth noting that there are separate trials available for those under 18 and over 65 years old - with a total of 50 and 61 respective trials dedicated to these age groups."

Answered by AI

What is the current number of individuals participating in this research project?

"Yes, the information on clinicaltrials.gov suggests that this investigation is currently seeking volunteers. The trial was first listed on 3/1/2023 and its last update occurred on 3/21/2024. Enrollment calls for 20 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

2023. "Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06335719.

All > Bells Palsy > Cleveland