Facial ParesisPhase 4FacialReinnNCT01833221
Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
A Phase 4 study testing injection of 1% lidocaine, 2mL for facial nerve block in people with Facial Paresis, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Facial Paresis
- What is being tested?
- injection of 1% lidocaine, 2mL for facial nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
The purpose of this study is to determine the physiology of nerve healing and the neurotization of the facial muscles after lengthening temporalis myoplasty.
Read the 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.
- Conditions
- Facial Paresis
- Being tested
- injection of 1% lidocaine, 2mL for facial nerve block
- Keywords
- facial palsy, lengthening temporalis myoplasty, neurotization of facial muscles
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of 1% lidocaine, 2mL for facial nerve blockDrug
Also called facial nerve block following the O'Brien modified technique
injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk
| Study group | Role | What they receive |
|---|---|---|
| Neurotized facial muscle patients | Experimental | injection of 1% lidocaine, 2mL for facial nerve block Receives: Drug: injection of 1% lidocaine, 2mL for facial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial muscle contraction after nerve block
clinical and photographical study will be performed before and after neve block and relative contractibility state will be recorded
Measured: 30 minutes after lidocaine injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: The study reach enough significance at the intermediary analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Facial ParesisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Labbé, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833221
- Sponsor's protocol ID
- 10-159
- Acronym
- FacialReinn
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2013
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheney ML, McKenna MJ, Megerian CA, West C, Elahi MM. Trigeminal neo-neurotization of the paralyzed face. Ann Otol Rhinol Laryngol. 1997 Sep;106(9):733-8. doi: 10.1177/000348949710600903.
PubMed 9302902Fournier HD, Denis F, Papon X, Hentati N, Mercier P. An anatomical study of the motor distribution of the mandibular nerve for a masseteric-facial anastomosis to restore facial function. Surg Radiol Anat. 1997;19(4):241-4. doi: 10.1007/BF01627866.
PubMed 9381330Godwin Y, Tomat L, Manktelow R. The use of local anesthetic motor block to demonstrate the potential outcome of depressor labii inferioris resection in patients with facial paralysis. Plast Reconstr Surg. 2005 Sep 15;116(4):957-61. doi: 10.1097/01.prs.0000178043.15510.75.
PubMed 16163078Guerreschi P, Labbe D, Carluer L, Drillet C, Benateau H. [Manktelow's test for the use of botulic toxin]. Ann Chir Plast Esthet. 2008 Feb;53(1):59-62. doi: 10.1016/j.anplas.2007.04.010. Epub 2007 Jun 27. French.
PubMed 17600609Labbe D, Huault M. Lengthening temporalis myoplasty and lip reanimation. Plast Reconstr Surg. 2000 Apr;105(4):1289-97; discussion 1298.
PubMed 10744217Lifchez SD, Matloub HS, Gosain AK. Cortical adaptation to restoration of smiling after free muscle transfer innervated by the nerve to the masseter. Plast Reconstr Surg. 2005 May;115(6):1472-9; discussion 1480-2. doi: 10.1097/01.prs.0000160266.81504.71.
PubMed 15861049Petropoulos AE, Cheney ML. Induction of facial muscle neurotization by temporalis muscle transposition: literature review and animal model evaluation using horseradish peroxidase uptake. J Otolaryngol. 2000 Feb;29(1):40-6.
PubMed 10709171Schimek F, Fahle M. Techniques of facial nerve block. Br J Ophthalmol. 1995 Feb;79(2):166-73. doi: 10.1136/bjo.79.2.166.
PubMed 7696239
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Reinnervation of Facial Muscles After Lengthening Temporalis Myoplasty
- ClinicalTrials.gov ID
- NCT01833221
- Acronym / sponsor ID
- FacialReinn / 10-159
- Conditions
- Facial Paresis
- Keywords
- facial palsy, lengthening temporalis myoplasty, neurotization of facial muscles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study reach enough significance at the intermediary analysis
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurotized facial muscle patients | Experimental | Drug: injection of 1% lidocaine, 2mL for facial nerve blockinjection of 1% lidocaine, 2mL for facial nerve block |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of 1% lidocaine, 2mL for facial nerve blockAlso: facial nerve block following the O'Brien modified techniqueinjection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk | Drug | Neurotized facial muscle patients |
Primary outcome
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
Results and safety
The study was stopped early (reason given: The study reach enough significance at the intermediary analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Background: PubMed 9302902Cheney ML, McKenna MJ, Megerian CA, West C, Elahi MM. Trigeminal neo-neurotization of the paralyzed face. Ann Otol Rhinol Laryngol. 1997 Sep;106(9):733-8. doi: 10.1177/000348949710600903.
- Background: PubMed 9381330Fournier HD, Denis F, Papon X, Hentati N, Mercier P. An anatomical study of the motor distribution of the mandibular nerve for a masseteric-facial anastomosis to restore facial function. Surg Radiol Anat. 1997;19(4):241-4. doi: 10.1007/BF01627866.
- Background: PubMed 16163078Godwin Y, Tomat L, Manktelow R. The use of local anesthetic motor block to demonstrate the potential outcome of depressor labii inferioris resection in patients with facial paralysis. Plast Reconstr Surg. 2005 Sep 15;116(4):957-61. doi: 10.1097/01.prs.0000178043.15510.75.
- Background: PubMed 17600609Guerreschi P, Labbe D, Carluer L, Drillet C, Benateau H. [Manktelow's test for the use of botulic toxin]. Ann Chir Plast Esthet. 2008 Feb;53(1):59-62. doi: 10.1016/j.anplas.2007.04.010. Epub 2007 Jun 27. French.
- Background: PubMed 10744217Labbe D, Huault M. Lengthening temporalis myoplasty and lip reanimation. Plast Reconstr Surg. 2000 Apr;105(4):1289-97; discussion 1298.
- Background: PubMed 15861049Lifchez SD, Matloub HS, Gosain AK. Cortical adaptation to restoration of smiling after free muscle transfer innervated by the nerve to the masseter. Plast Reconstr Surg. 2005 May;115(6):1472-9; discussion 1480-2. doi: 10.1097/01.prs.0000160266.81504.71.
- Background: PubMed 10709171Petropoulos AE, Cheney ML. Induction of facial muscle neurotization by temporalis muscle transposition: literature review and animal model evaluation using horseradish peroxidase uptake. J Otolaryngol. 2000 Feb;29(1):40-6.
- Background: PubMed 7696239Schimek F, Fahle M. Techniques of facial nerve block. Br J Ophthalmol. 1995 Feb;79(2):166-73. doi: 10.1136/bjo.79.2.166.
Related trials for Facial Paresis
RecruitingObservational study
Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies
Congenital Fibrosis of Extraocular Muscles, Duane Retraction Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Labbé, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing injection of 1% lidocaine, 2mL for facial nerve block in people with Facial Paresis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study reach enough significance at the intermediary analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial muscle contraction after nerve block (time frame: 30 minutes after lidocaine injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833221, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2016.