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RecruitingNCT06335719Updated Sep 28, 2026

Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

An interventional study of BES and Standard of Care surgery in Facial Paralysis, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Mar 2023, registered Mar 2024).
  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Facial Paralysis

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03

In context

Facial Paralysis

81 studies on the registry are indexed under Facial Paralysis; 28 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 59 interventional studies indexed under Facial Paralysis.

Browse Facial Paralysis studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Browse The Cleveland Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    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.

    Procedure: BES

  • Experimental
    Control Group

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

    Procedure: Standard of Care surgery

Interventions

  • ProcedureBES

    Nerve biopsies during surgery + brief electrical stimulation therapy

  • ProcedureStandard of Care surgery

    Nerve biopsies during surgery - no brief electrical stimulation therapy

06

What researchers measure

Primary outcomes

  1. 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.

    Efficacy evaluation

    Time frame: 24 months

Secondary outcomes

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

    Evaluation of Clinical Outcomes

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
    Recruiting
    • Hana Rosen, MD · Contactrosenh@ccf.org · 2164447018
    • John O'Neill, BS · Contactoneillj2@ccf.org · 4405062611
    • Patrick Byrne, MD · Principal investigator
    • Michael Fritz, MD · Sub investigator
    • Brandon Hopkins, MD · Sub investigator
    • Peter Ciolek, MD · Sub investigator
    • Dane Genther, MD · Sub investigator
    • Stephen Hadford, MD · Sub investigator
    • Peng Ding, MD · Sub investigator
    • Derek Vos, BS · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2023 (actual). Primary completion is estimated for Dec 2026, 45 months after the start.

Of 37 interventional studies with no phase under Facial Paralysis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 68. This study's planned 45 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2024
First posted
Mar 28, 2024
StartActual
Mar 1, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06335719
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Mar 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 28, 2026

Study contacts

Hana Rosen, MD
Contact
rosenh@ccf.org
216-444-7018
John O'Neill, MD
Contact
oneillj2@ccf.org
440-445-8175
Patrick Byrne, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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