Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06335719
Status
Recruiting
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Conditions

  • Facial Paralysis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • Experimental: Control Group
    Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.

Primary Outcome Measure

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. [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Hana Rosen, MD
[email protected]
2164447018
John O'Neill, BS
[email protected]
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)

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By research site
Cleveland Clinic Foundation· Cleveland, OH

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