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Clinical Trials/NCT01833221
NCT01833221TerminatedPhase 4

Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty

University Hospital, Caen1 site in 1 country10 target enrollmentStarted: April 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
10
Locations
1
Primary Endpoint
Facial muscle contraction after nerve block

Study Overview

Brief Summary

The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.

Detailed Description

The investigators want to study the physiology of nerve healing after lengthening temporalis myoplasty done for facial nerve impairment. The investigators already observed few cases of spontaneous neurotization and the investigators want to check the nerve command of the facial muscles. Clinical and photographic evaluations will be performed before and after a facial nerve block using 1% lidocaine.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
6 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patient who were operated for a facial paralysis by the lengthening temporalis myoplasty procedure in the University Hospital of Caen and who present signs of contraction of the facial muscles on the plasy side after the procedure.

Exclusion Criteria

  • Patient with contraindications to the injection of lidocaine
  • Patient treated with beta-blocker
  • Patient on anti-coagulants
  • Pathology cause of facial paralysis evolving
  • Pregnant or lactating
  • Patient incapacitated adult
  • Patient undergoing another study at the same time

Arms & Interventions

Neurotized facial muscle patients

Experimental

injection of 1% lidocaine, 2mL for facial nerve block

Intervention: injection of 1% lidocaine, 2mL for facial nerve block (Drug)

Outcomes

Primary Outcomes

Facial muscle contraction after nerve block

Time Frame: 30 minutes after lidocaine injection

clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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