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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | 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. |
|
| Control Group | Experimental | Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BES | Procedure | Nerve biopsies during surgery + brief electrical stimulation therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hana Rosen, MD | Contact | 216-444-7018 | rosenh@ccf.org | |
| John O'Neill, MD | Contact | 440-445-8175 | oneillj2@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Patrick Byrne, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D005158 | Facial Paralysis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C012210 | BES |
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Patients will undergo all the standard steps of the facial reanimation procedures. The difference in care is 2/3 participants may receive the brief electrical stimulation therapy.
Other 1/3 of study participants will undergo the surgery as they normally would if they had not chosen to participate.
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This is a randomized, controlled, double-blinded (patient and evaluator) prospective study. Plan is to enroll up to 30 patients, with a minimum of 20 completing full follow-up. Randomization 2:1 treatment to control due to previous peripheral nerve research demonstrating intraoperative stimulation accelerates axonal regeneration
| Standard of Care surgery |
| Procedure |
Nerve biopsies during surgery - no brief electrical stimulation therapy |
|
| D009422 |
| Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |