Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Facial Paralysis Clinical Trial

Official title:

Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335719
• Other study ID #: IRB #22-926
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: The Cleveland Clinic
• Contact: Hana Rosen, MD
• Phone: 216-444-7018
• Email: rosenh[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross face nerve graft facial reanimation surgery.

Description:

Participants that choose to enroll in this study will be randomly assigned in a 2:1 ratio to a "treatment" or "control" group. In either group, patients will receive the same care as they normally would except for two minor differences. First, patients in both groups undergo nerve biopsies during surgery; these biopsies do not affect the length or outcome of surgery. Second, the treatment group will receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery. The purpose of this study is 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 and to evaluate clinical outcomes of treatment and control groups using clinician graded, patient reported, and objective smile metric.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients 18-80 years-old with unilateral facial paralysis who are candidates for two- stage CFNG smile reanimation surgery (i.e. CFNG-driven free gracilis muscle transfer (FGMT) or dual innervation FGMT).

2. Agree to participate in the study.

Exclusion Criteria:

1. Bilateral facial paralysis

2. Age less than 18 years-old or older than 80 years-old

3. Comorbid medical condition preventing two-stage CFNG surgery

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Paralysis

Intervention

Procedure:
• BES
Nerve biopsies during surgery + brief electrical stimulation therapy
• Standard of Care surgery
Nerve biopsies during surgery - no brief electrical stimulation therapy

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months
Secondary	To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.	Evaluation of Clinical Outcomes	24 months