Facial ParalysisNCT06538103
Eye Soft Surgery for Facial Sinkynesis
A study testing Eye soft surgery and Physical Rehabilitation in people with Facial Paralysis and Sinkynesis, run by University of Catania at 1 site in Italy.
Trial summary
Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Facial Paralysis, Sinkynesis
- What is being tested?
- Eye soft surgery and Physical Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jan 2022to 30 Nov 2023
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people over 18 years old
- willingness to participate
- acute/new onset of FP (less than 15 days)
Who cannot join
- neuro-inflammatory diseases (e.g., Multiple Sclerosis)
- FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
- FP from middle ear infections or untreated cholesteatoma
- severe cognitive or psychological disorders
- non-consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.
Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.
This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.
25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.
- Conditions
- Facial Paralysis, Sinkynesis
- Being tested
- Eye soft surgery, Physical Rehabilitation
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye soft surgeryProcedure or surgery
Also called Lower eyelid surgery
Early lower eyelid surgery will be performed in accordance with the protocol previously described by Di Stadio, with medial or lateral eyelid lifting surgery as indicated. The indication for eye surgery are in case of ectropion (exposure of the conjunctiva due to a reduction in tension of the anterior compartment of the eye muscle) and lagophthalmos (incomplete /abnormal closure of the eye with eyelid in closed position) a lateral lower eyelid lifting surgery is performed. otherwise, in presence of epiphora (the eversion of the lachrymal point) and lagophthalmos medial lower eyelid lifting surgery is done.
Physical RehabilitationOther
Also called Kabat
Kabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present) Receives: Procedure: Eye soft surgery; Other: Physical Rehabilitation |
| Control | Active comparator | Kabat therapy and neuromuscular reeducation (NMR) at home Receives: Other: Physical Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinkinesis
Presence or absence
Measured: 3, 6, 12, 24 months
Secondary outcomes (2)
Recovery of Facial motility
ADS will be used to evaluate the recovery of facial motility
Measured: 3, 6, 12, 24 months
Time to recover facial motility
Evaluation of months needed to recover
Measured: 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start18 Jan 2022
- Primary completion15 Mar 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arianna Di Stadio, University of Catania
- Investigators
- Arianna Di Stadio, MD, PhD, Principal investigator, UniCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538103
- Sponsor's protocol ID
- UniCT2022
- Status last verified
- Jul 2024
- First submitted
- 31 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared after data publication
Publications
Di Stadio A. Eyelid lifting for ectropion and scleral show in facial palsy disease. ORL J Otorhinolaryngol Relat Spec. 2014;76(6):329-35. doi: 10.1159/000369623. Epub 2015 Jan 8.
PubMed 25572490Di Stadio A. Another Scale for the Assessment of Facial Paralysis? ADS Scale: Our Proposition, How to Use It. J Clin Diagn Res. 2015 Dec;9(12):MC08-11. doi: 10.7860/JCDR/2015/15366.6953. Epub 2015 Dec 1.
PubMed 26814596Di Stadio A, Gambacorta V, Ralli M, Pagliari J, Longari F, Greco A, Ricci G. Facial taping as biofeedback to improve the outcomes of physical rehab in Bell's palsy: preliminary results of a randomized case-control study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1693-1698. doi: 10.1007/s00405-020-06193-3. Epub 2020 Jul 17.
PubMed 32681234Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.
PubMed 27734980Barbara M, Antonini G, Vestri A, Volpini L, Monini S. Role of Kabat physical rehabilitation in Bell's palsy: a randomized trial. Acta Otolaryngol. 2010;130(1):167-72. doi: 10.3109/00016480902882469.
PubMed 19430987Di Stadio A, Ralli M, De Luca P, Sossamon J, Frohman TC, Altieri M, La Mantia I, Ferlito S, Frohman EM, Brenner MJ. Combining early lower eyelid surgery with neuromuscular retraining for synkinesis prevention after facial palsy: the role of the eye in aberrant facial nerve regeneration. Front Neurol. 2024 Sep 18;15:1443591. doi: 10.3389/fneur.2024.1443591. eCollection 2024.
PubMed 39359872
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.
- ClinicalTrials.gov ID
- NCT06538103
- Acronym / sponsor ID
- UniCT2022
- Conditions
- Facial Paralysis, Sinkynesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 5 Aug 2024 (actual)
- 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.
Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.
This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.
25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Eye soft surgery, Other: Physical RehabilitationKabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present) |
| Control | Active comparator | Other: Physical RehabilitationKabat therapy and neuromuscular reeducation (NMR) at home |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- people over 18 years old
- willingness to participate
- acute/new onset of FP (less than 15 days)
Key exclusion criteria (5 listed)
- neuro-inflammatory diseases (e.g., Multiple Sclerosis)
- FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
- FP from middle ear infections or untreated cholesteatoma
- severe cognitive or psychological disorders
- non-consent to participate in the study
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 |
|---|---|---|
| Eye soft surgeryAlso: Lower eyelid surgeryEarly lower eyelid surgery will be performed in accordance with the protocol previously described by Di Stadio, with medial or lateral eyelid lifting surgery as indicated. The indication for eye surgery are in case of ectropion (exposure of the conjunctiva due to a reduction in tension of the anterior compartment of the eye muscle) and lagophthalmos (incomplete /abnormal closure of the eye with eyelid in closed position) a lateral lower eyelid lifting surgery is performed. otherwise, in presence of epiphora (the eversion of the lachrymal point) and lagophthalmos medial lower eyelid lifting surgery is done. | Procedure or surgery | Treatment |
| Physical RehabilitationAlso: KabatKabat therapy and neuromuscular reeducation (NMR) at home Kabat therapy involved thrice-weekly 35-minute sessions. | Other | Control, Treatment |
Primary outcome
Sinkinesis
Time frame: 3, 6, 12, 24 months
Presence or absence
2 secondary outcomes
Recovery of Facial motility
Time frame: 3, 6, 12, 24 months
Time to recover facial motility
Time frame: 3, 6, 12, 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Results publication: PubMed 25572490Di Stadio A. Eyelid lifting for ectropion and scleral show in facial palsy disease. ORL J Otorhinolaryngol Relat Spec. 2014;76(6):329-35. doi: 10.1159/000369623. Epub 2015 Jan 8.
- Results publication: PubMed 26814596Di Stadio A. Another Scale for the Assessment of Facial Paralysis? ADS Scale: Our Proposition, How to Use It. J Clin Diagn Res. 2015 Dec;9(12):MC08-11. doi: 10.7860/JCDR/2015/15366.6953. Epub 2015 Dec 1.
- Results publication: PubMed 32681234Di Stadio A, Gambacorta V, Ralli M, Pagliari J, Longari F, Greco A, Ricci G. Facial taping as biofeedback to improve the outcomes of physical rehab in Bell's palsy: preliminary results of a randomized case-control study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1693-1698. doi: 10.1007/s00405-020-06193-3. Epub 2020 Jul 17.
- Results publication: PubMed 27734980Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.
- Results publication: PubMed 19430987Barbara M, Antonini G, Vestri A, Volpini L, Monini S. Role of Kabat physical rehabilitation in Bell's palsy: a randomized trial. Acta Otolaryngol. 2010;130(1):167-72. doi: 10.3109/00016480902882469.
- Derived from this study: PubMed 39359872Di Stadio A, Ralli M, De Luca P, Sossamon J, Frohman TC, Altieri M, La Mantia I, Ferlito S, Frohman EM, Brenner MJ. Combining early lower eyelid surgery with neuromuscular retraining for synkinesis prevention after facial palsy: the role of the eye in aberrant facial nerve regeneration. Front Neurol. 2024 Sep 18;15:1443591. doi: 10.3389/fneur.2024.1443591. eCollection 2024.
- Individual participant dataSharing planned: No. The data will be shared after data publication
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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.
Arianna Di Stadio, MD, PhD principal investigator
UniCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye soft surgery and Physical Rehabilitation in people with Facial Paralysis and Sinkynesis, run by University of Catania at 1 site in Italy.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Aug 2024. 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 Italy. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sinkinesis (time frame: 3, 6, 12, 24 months). 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 NCT06538103, which also lists 6 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 5 Aug 2024.