BlepharospasmEarly Phase 1NCT02765113
Two Different Surgical Methods of Blepharospasm
A Early Phase 1 study testing Facial nerve combing and Facial and Trigeminal nerve combing in people with Blepharospasm, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
1. Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Blepharospasm
- What is being tested?
- Facial nerve combing and Facial and Trigeminal nerve combing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2017
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral blepharospasm
- Clinical symptoms more than 1 years.
- Patients who are willing to undergo surgery.
- Preoperative patients who had not been treated with botulinum toxin.
Who cannot join
- Patients with serious heart and lung dysfunction can not tolerate surgery.
- The clinical symptoms of the patients less than 1 years.
- Patients who received local botulinum toxin treatment for a long time.
- Patients with severe mental disorders.
About this study
Official title: Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
- Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
- Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
- Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
- Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
- Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
Read the detailed description
Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
- Conditions
- Blepharospasm
- Being tested
- Facial nerve combing, Facial and Trigeminal nerve combing
- Medical subject headings
- Blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial nerve combingProcedure or surgery
Facial nerve combing:To sort out the facial nerve using the nerve combing knife.
MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.
Facial and Trigeminal nerve combingProcedure or surgery
Facial nerve combing:To sort out the facial nerve using the nerve combing knife.
Trigeminal nerve combing:To sort out the trigeminal nerve using the nerve combing knife.
MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.
| Study group | Role | What they receive |
|---|---|---|
| Facial nerve combing | Active comparator | Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group. Receives: Procedure: Facial nerve combing |
| Facial and Trigeminal nerve combing | Active comparator | Facial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group. Receives: Procedure: Facial and Trigeminal nerve combing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms in patients with blepharospasm
Evaluation of patients with blepharospasm by rating scale.
Measured: up to 12 months
Secondary outcomes (2)
Incidence of facial numbness
Measured: up to 12 months
Incidence of facial paralysis
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharospasmStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765113
- Sponsor's protocol ID
- XH-16-008
- Status last verified
- Apr 2016
- First submitted
- 14 Apr 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
- ClinicalTrials.gov ID
- NCT02765113
- Acronym / sponsor ID
- XH-16-008
- Conditions
- Blepharospasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 May 2016 (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.
- Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
- Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
- Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
- Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
- Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
Detailed description
Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial nerve combing | Active comparator | Procedure: Facial nerve combingFacial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group. |
| Facial and Trigeminal nerve combing | Active comparator | Procedure: Facial and Trigeminal nerve combingFacial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with bilateral blepharospasm
- Clinical symptoms more than 1 years.
- Patients who are willing to undergo surgery.
- Preoperative patients who had not been treated with botulinum toxin.
Key exclusion criteria (4 listed)
- Patients with serious heart and lung dysfunction can not tolerate surgery.
- The clinical symptoms of the patients less than 1 years.
- Patients who received local botulinum toxin treatment for a long time.
- Patients with severe mental disorders.
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 |
|---|---|---|
| Facial nerve combingFacial nerve combing:To sort out the facial nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression. | Procedure or surgery | Facial nerve combing |
| Facial and Trigeminal nerve combingFacial nerve combing:To sort out the facial nerve using the nerve combing knife. Trigeminal nerve combing:To sort out the trigeminal nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression. | Procedure or surgery | Facial and Trigeminal nerve combing |
Primary outcome
Improvement of symptoms in patients with blepharospasm
Time frame: up to 12 months
Evaluation of patients with blepharospasm by rating scale.
2 secondary outcomes
Incidence of facial numbness
Time frame: up to 12 months
Incidence of facial paralysis
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Individual participant dataSharing planned: Yes
Related trials for Blepharospasm
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RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
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Brain Networks in Dystonia
Spasmodic Dysphonia, Singer's Dystonia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Facial nerve combing and Facial and Trigeminal nerve combing in people with Blepharospasm, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 4 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 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of symptoms in patients with blepharospasm (time frame: up to 12 months). 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 May 2016.