Bell PalsyNCT02179684
Surgery or Clincial Follow up, in Patients With Bell' s Palsy
A study testing Baby-sitter surgery N. fascialis and Conventional treatment and follow-up in people with Bell Palsy, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Baby-sitter surgery N. fascialis and Conventional treatment and follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSweden
- Study dates
- Nov 2013to Nov 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Bell´s Palsy
- Men and women aged 18-55 y
- Score < 70 according to Sunny Brook scale (SB)
- Signed informed consent
Who cannot join
- High bloodpressure
- Diabetes
- Pregnancy
- Currently on immunodepressive treatment
- Smoker
- Psychiatric disorder
- Cor incomp, according to NYHA grade: IV, kidney or liver disorder, that greatly influence patienst ability to receive surgery
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska University Hospital
Stockholm, Solna, SE-17176
Uppsala Akademiska Hospital, EENT department
Uppsala, Uppsala County, SE-751 85
About this study
Official title: Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.
The purpose of this study is to investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.
- Conditions
- Bell Palsy
- Being tested
- Baby-sitter surgery N. fascialis, Conventional treatment and follow-up
- Keywords
- Cranial Nerve fascial paresis
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby-sitter surgery N. fascialisProcedure or surgery
Conventional treatment and follow-upOther
Patient´s with Bells´palasy are treated with conventional treatment and follow-up
| Study group | Role | What they receive |
|---|---|---|
| Early surgery | Experimental | Patienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method Receives: Procedure: Baby-sitter surgery N. fascialis |
| Conventional treatment and follow-up | Active comparator | Patienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model. Receives: Other: Conventional treatment and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunny Brook (SB) score > 70
Patients with Bell´s Palsy that has been randomized to conventional treatment or early surgical intervention are scored according to SB after 12 month of study participation.
Measured: 1 year
Secondary outcomes (2)
Facial Disability Index
Change in Facial Disability Index
Measured: 15 month
FaCe
Change in FaCe quality score
Measured: 15 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2018 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malou Hultcrantz, Karolinska Institutet
- Investigators
- Malou Hultcrantz, M.D prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179684
- Sponsor's protocol ID
- Bell´sPalsy
- Status last verified
- Jun 2014
- First submitted
- 30 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery or Clinical Follow-up in Patients With Bell's Palsy. A Prospective, Parallell, Single Center, Randomized , Open Surgery Clinical Study.
- ClinicalTrials.gov ID
- NCT02179684
- Acronym / sponsor ID
- Bell´sPalsy
- Conditions
- Bell Palsy
- Keywords
- Cranial Nerve fascial paresis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 2 Jul 2014 (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 investigate if an early surgical intervention on patienst with Bell´s Palsy has a better impact on their facial muscular function and their quality of life as compared to conventional therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early surgery | Experimental | Procedure: Baby-sitter surgery N. fascialisPatienst with Bell´s Palsy with an early surgical intervention (< 3month), according to 'baby-sitter' method |
| Conventional treatment and follow-up | Active comparator | Other: Conventional treatment and follow-upPatienst with Bell´s Palsy treated with conventional treatment and standardized physiotherapy according to Jaqueline Diels model. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with Bell´s Palsy
- Men and women aged 18-55 y
- Score < 70 according to Sunny Brook scale (SB)
- Signed informed consent
Key exclusion criteria (7 listed)
- High bloodpressure
- Diabetes
- Pregnancy
- Currently on immunodepressive treatment
- Smoker
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 |
|---|---|---|
| Baby-sitter surgery N. fascialis | Procedure or surgery | Early surgery |
| Conventional treatment and follow-upPatient´s with Bells´palasy are treated with conventional treatment and follow-up | Other | Conventional treatment and follow-up |
Primary outcome
Sunny Brook (SB) score > 70
Time frame: 1 year
Patients with Bell´s Palsy that has been randomized to conventional treatment or early surgical intervention are scored according to SB after 12 month of study participation.
2 secondary outcomes
Facial Disability Index
Time frame: 15 month
FaCe
Time frame: 15 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2014.
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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.
Malou Hultcrantz, M.D prof. principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby-sitter surgery N. fascialis and Conventional treatment and follow-up in people with Bell Palsy, run by Karolinska Institutet at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 2 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Sunny Brook (SB) score > 70 (time frame: 1 year). 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 2 Jul 2014.