Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335719
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-15
Brief Title:
Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Intraoperative Brief Electrical Stimulation to Improve Cross-Face Nerve Grafting Outcomes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Participants that choose to enroll in this study will be randomly assigned in a 21 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None