Facial ParalysisNCT05191719
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
A study testing Botox injection and Neurotomy in people with Facial Paralysis and Facial Palsy, run by Rebecka Ohm at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Facial Paralysis, Facial Palsy, Peripheral Facial Palsy
- What is being tested?
- Botox injection and Neurotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2022to Feb 2026
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Synkinesis following peripheral facial palsy
- Sunnybrook score <61
- Botox injections at least 3 times a year
- Have received at least 3 Botox injections
- Botox injections not satisfying treatment
- Read and signed written consent
Who cannot join
- Synkinesis since less than 2 years
- Contractures in facial muscles
- Other planned surgery in the face during study period
- Smoking
- Uncontrolled hypertension
- Diabetes mellitus
- Pregnancy or breast feeding
- Severe systemic disease (ASA 3-4)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital/Karolinska Institute
Stockholm
Rebecka Ohm
Birgit Stark
About this study
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
Read the detailed description
Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve.
Surgical procedure:
Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact.
Evaluation procedure:
Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods:
- Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study
- Neurophysiological measurements,
- Quality of life, measured with validated questionnaires FaCE, FDI, SAQ
- Reports of potential side effects, using Clavien-Dindo classification as well as free text
- Conditions
- Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis
- Being tested
- Botox injection, Neurotomy
- Medical subject headings
- Facial Paralysis, Bell Palsy, Synkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox injectionProcedure or surgery
Comparator, current gold standard
NeurotomyProcedure or surgery
Surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Botox | Active comparator | Not described Receives: Procedure: Botox injection; Procedure: Neurotomy |
| Neurotomy | Experimental | Not described Receives: Procedure: Botox injection; Procedure: Neurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunnybrook facial grading scale
Improvement through less synkinesis and better voluntary movement
Measured: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Secondary outcomes (7)
Quality of life questionnaire
Facial Clinimetric Evaluation Scale (FaCE)
Measured: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Facial Disability Index (FDI)
Measured: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Synkinesis Assessment Questionnaire (SAQ)
Measured: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Neurophysiological examination, electromyography (EMG).
Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference).
Measured: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery
Number of Botox injections
Decrease to no future need
Measured: Baseline, 12 months after surgery
Side effects
Clavien-Dindo Classification
Measured: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Side effects
Free text, in order to capture all possible side effects of treatments.
Measured: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Feb 2022
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All study participants are evaluated with and without the effect Botox treatment before surgery. Botox is the gold standard treatment and used as a comparator. As all study patients have failed current evidence based treatment options, a comparative group not receiving treatment would imply a strong information bias.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecka Ohm
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rebecka Ohm, Karolinska University Hospital
- Investigators
- Birgit Stark, MD, PhD, Principal investigator, Karolinska Institute/Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191719
- Sponsor's protocol ID
- K2018-5656
- Status last verified
- Oct 2023
- First submitted
- 7 Nov 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
- ClinicalTrials.gov ID
- NCT05191719
- Acronym / sponsor ID
- K2018-5656
- Conditions
- Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Rebecka OhmUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Jan 2022 (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.
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
Detailed description
Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve.
Surgical procedure:
Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact.
Evaluation procedure:
Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods:
- Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study
- Neurophysiological measurements,
- Quality of life, measured with validated questionnaires FaCE, FDI, SAQ
- Reports of potential side effects, using Clavien-Dindo classification as well as free text
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All study participants are evaluated with and without the effect Botox treatment before surgery. Botox is the gold standard treatment and used as a comparator. As all study patients have failed current evidence based treatment options, a comparative group not receiving treatment would imply a strong information bias.
| Arm | Type | Receives |
|---|---|---|
| Botox | Active comparator | Procedure: Botox injection, Procedure: Neurotomy |
| Neurotomy | Experimental | Procedure: Botox injection, Procedure: Neurotomy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Synkinesis following peripheral facial palsy
- Sunnybrook score <61
- Botox injections at least 3 times a year
- Have received at least 3 Botox injections
- Botox injections not satisfying treatment
Key exclusion criteria (8 listed)
- Synkinesis since less than 2 years
- Contractures in facial muscles
- Other planned surgery in the face during study period
- Smoking
- Uncontrolled hypertension
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 |
|---|---|---|
| Botox injectionComparator, current gold standard | Procedure or surgery | Botox, Neurotomy |
| NeurotomySurgical procedure | Procedure or surgery | Botox, Neurotomy |
Primary outcome
Sunnybrook facial grading scale
Time frame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Improvement through less synkinesis and better voluntary movement
7 secondary outcomes
Quality of life questionnaire
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Quality of life questionnaire
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Neurophysiological examination, electromyography (EMG).
Time frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery
Number of Botox injections
Time frame: Baseline, 12 months after surgery
Side effects
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Side effects
Time frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Birgit Stark, MD, PhD principal investigator
Karolinska Institute/Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox injection and Neurotomy in people with Facial Paralysis and Facial Palsy, run by Rebecka Ohm at 1 site in Sweden.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rebecka Ohm, MD, PhDStud. (+4651770000, rebecka.ohm@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunnybrook facial grading scale (time frame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2023.