Intraoperativ elektrisk stimulering for at forbedre resultatet af nervetransplantation
Intraoperativ kort elektrisk stimulering for at forbedre resultaterne af cross-face nervetransplantation
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hana Rosen, MD
- Telefonnummer: 216-444-7018
- E-mail: rosenh@ccf.org
Undersøgelse Kontakt Backup
- Navn: John O'Neill, MD
- Telefonnummer: 440-445-8175
- E-mail: oneillj2@ccf.org
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195
- Rekruttering
- Cleveland Clinic Foundation
-
Kontakt:
- John O'Neill, BS
- Telefonnummer: 4405062611
- E-mail: oneillj2@ccf.org
-
Ledende efterforsker:
- Patrick Byrne, MD
-
Underforsker:
- Michael Fritz, MD
-
Underforsker:
- Brandon Hopkins, MD
-
Underforsker:
- Peter Ciolek, MD
-
Underforsker:
- Dane Genther, MD
-
Underforsker:
- Stephen Hadford, MD
-
Underforsker:
- Peng Ding, MD
-
Underforsker:
- Derek Vos, BS
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Kontakt:
- Hana Rosen, MD
- Telefonnummer: 2164447018
- E-mail: rosenh@ccf.org
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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).
- Agree to participate in the study.
Exclusion Criteria:
- Bilateral facial paralysis
- Age less than 18 years-old or older than 80 years-old
- Comorbid medical condition preventing two-stage CFNG surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Nerve biopsies during surgery + brief electrical stimulation therapy |
|
Eksperimentel: Control Group
Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation. |
Nerve biopsies during surgery - no brief electrical stimulation therapy |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 24 months
|
Efficacy evaluation |
24 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate clinical outcomes of treatment and control groups using patient reported, and IRB approved CCF Facial Nerve Survey.
Tidsramme: 24 months
|
Evaluation of Clinical Outcomes |
24 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Patrick Byrne, MD, The Cleveland Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB #22-926
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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