Hemifacial SpasmNCT04474977
Microvascular Decompressive Surgery for Hemifacial Spasm
An observational study of Hemifacial Spasm, run by Assiut University.
Trial summary
Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm. Assess safety and efficacy of Micro vascular decompression. Improve the outcome of these patients and decease rate of recurrence and complications. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemifacial Spasm
- What is being tested?
- Microvascular Decompressive Surgery
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Mar 2023
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The sample size calculated by sample size calculator software according to: 1. confidence interval : 95% 2. power : 80% 3. P-value : 5% 4. Prevalence : 0.79/100000 5. Population size: 110,000 referenced by Assiut health directory statistics 2018 All cases that fulfil the selection criteria that will be admitted in the department of neurosurgery at Assiut university hospital with expected size of at least 30 patients
Who may be able to join
- Primary Hemi facial spasm Unilateral Adults 20-60 years Clinical Diagnosis confirmed by Facial Evoked potential \& Neuroimaging
Who cannot join
- Secondary Hemi facial spasm caused by intracranial masses or other lesions Recurrent Hemi facial spasm Patients who are unfit for any neurosurgical interventions.
About this study
Official title: Microvascular Decompressive Surgery for Hemifacial Spasm: Nuances of Technique and Outcome
- Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm.
- Assess safety and efficacy of Micro vascular decompression.
- Improve the outcome of these patients and decease rate of recurrence and complications.
Read the detailed description
Hemi facial spasm (HFS), a term described in 1905 by Babinski but first reported by Schultz in 1875, is a highly morbid movement disorder characterized by intermittent involuntary movement of muscles innervated by the facial nerve.
(HFS) affects roughly 10 in 100,000 individuals in fifth or sixth decades of life.
Primary HFS is commonly attributed to vascular loops compressing the seventh cranial nerve at its exit zone from the brainstem. The facial nerve compression is thought to lead to ephaptic transmission and to hyperactivity of the facial nucleus, resulting in the involuntary facial movements.
Secondary HFS frequently follows peripheral facial palsy or may arise from facial nerve damage produced by tumours, demyelinating disorders, traumatisms, and infections accounting for 1-2 \& of HFS.
Over four in five primary HFS cases involve either anterior or posterior inferior cerebellar artery as the primary offender although vertebral artery, multiple vessels and veins may be involved.
EMG recordings confirm the diagnosis by showing a typical electrophysiological signature: clonic facial muscle contractions, hyperactivity, and synkinesis, lateral spread evoked responses.
Imaging can be useful for confirming that HFS is primary in nature and due to a neurovascular compression. In most cases (95% of the patients) the compressive vessel, generally an artery, is seen on MRI combined with MR-Angiography (MRA). High resolution T2-sequence is to be used to get good delineation of the facial nerve.
Many treatments for HFS have been reported, including pharmacological agents, botulinum toxin injection, facial nerve blockage, physical therapy, radiofrequency ablation, acupuncture, as well as facial nerve combing and microvascular decompression (MVD).
However, while MVD is effective, there are still significant postoperative complications.
- Conditions
- Hemifacial Spasm
- Being tested
- Microvascular Decompressive Surgery
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microvascular Decompressive SurgeryOther
Microvascular decompression for hemifacial spasm
What is being measured
The primary outcome is the main question the study is designed to answer.
Samsung Medical center Grading system for Severity of Hemifacial Spasm
Success rate by assessing the degree of hemifacial spasm pre and post-operative using the SMC grading system proposed by Lee et all
Measured: one month
Hearing Affection
Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss
Measured: one month
Recurrence
Recurrence rate within the duration of follow up
Measured: Six Month
Morbidity and mortality
Morbidity and mortality rates related to the procedure using modified Rankin Scale
Measured: Six Month
Secondary outcomes (1)
changes in facial evoked EMG
Detect the changes in facial evoked EMG preoperative and postoperative and its correlation to outcomes (esp. disappearance of lateral spread response)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
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 Hemifacial SpasmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Zanaty, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474977
- Sponsor's protocol ID
- Hemifacial Spasm
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. No abstract available. Undetermined Language.
PubMed 14921388Wu Y, Davidson AL, Pan T, Jankovic J. Asian over-representation among patients with hemifacial spasm compared to patients with cranial-cervical dystonia. J Neurol Sci. 2010 Nov 15;298(1-2):61-3. doi: 10.1016/j.jns.2010.08.017.
PubMed 20864122Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. doi: 10.1212/wnl.29.9_part_1.1261.
PubMed 573406Cui Z, Ling Z. Advances in microvascular decompression for hemifacial spasm. J Otol. 2015 Mar;10(1):1-6. doi: 10.1016/j.joto.2015.06.002. Epub 2015 Jul 26.
PubMed 29937774Hyun SJ, Kong DS, Park K. Microvascular decompression for treating hemifacial spasm: lessons learned from a prospective study of 1,174 operations. Neurosurg Rev. 2010 Jul;33(3):325-34; discussion 334. doi: 10.1007/s10143-010-0254-9. Epub 2010 Mar 27.
PubMed 20349099Sindou M, Mercier P. Microvascular decompression for hemifacial spasm: Outcome on spasm and complications. A review. Neurochirurgie. 2018 May;64(2):106-116. doi: 10.1016/j.neuchi.2018.01.001. Epub 2018 Feb 15.
PubMed 29454467
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Decompressive Surgery for Hemifacial Spasm: Nuances of Technique and Outcome
- ClinicalTrials.gov ID
- NCT04474977
- Acronym / sponsor ID
- Hemifacial Spasm
- Conditions
- Hemifacial Spasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 17 Jul 2020 (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.
- Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm.
- Assess safety and efficacy of Micro vascular decompression.
- Improve the outcome of these patients and decease rate of recurrence and complications.
Detailed description
Hemi facial spasm (HFS), a term described in 1905 by Babinski but first reported by Schultz in 1875, is a highly morbid movement disorder characterized by intermittent involuntary movement of muscles innervated by the facial nerve.
(HFS) affects roughly 10 in 100,000 individuals in fifth or sixth decades of life.
Primary HFS is commonly attributed to vascular loops compressing the seventh cranial nerve at its exit zone from the brainstem. The facial nerve compression is thought to lead to ephaptic transmission and to hyperactivity of the facial nucleus, resulting in the involuntary facial movements.
Secondary HFS frequently follows peripheral facial palsy or may arise from facial nerve damage produced by tumours, demyelinating disorders, traumatisms, and infections accounting for 1-2 \& of HFS.
Over four in five primary HFS cases involve either anterior or posterior inferior cerebellar artery as the primary offender although vertebral artery, multiple vessels and veins may be involved.
EMG recordings confirm the diagnosis by showing a typical electrophysiological signature: clonic facial muscle contractions, hyperactivity, and synkinesis, lateral spread evoked responses.
Imaging can be useful for confirming that HFS is primary in nature and due to a neurovascular compression. In most cases (95% of the patients) the compressive vessel, generally an artery, is seen on MRI combined with MR-Angiography (MRA). High resolution T2-sequence is to be used to get good delineation of the facial nerve.
Many treatments for HFS have been reported, including pharmacological agents, botulinum toxin injection, facial nerve blockage, physical therapy, radiofrequency ablation, acupuncture, as well as facial nerve combing and microvascular decompression (MVD).
However, while MVD is effective, there are still significant postoperative complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The sample size calculated by sample size calculator software according to: 1. confidence interval : 95% 2. power : 80% 3. P-value : 5% 4. Prevalence : 0.79/100000 5. Population size: 110,000 referenced by Assiut health directory statistics 2018 All cases that fulfil the selection criteria that will be admitted in the department of neurosurgery at Assiut university hospital with expected size of at least 30 patients
Key inclusion criteria (1 listed)
- Primary Hemi facial spasm Unilateral Adults 20-60 years Clinical Diagnosis confirmed by Facial Evoked potential \& Neuroimaging
Key exclusion criteria (1 listed)
- Secondary Hemi facial spasm caused by intracranial masses or other lesions Recurrent Hemi facial spasm Patients who are unfit for any neurosurgical interventions.
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 |
|---|---|---|
| Microvascular Decompressive SurgeryMicrovascular decompression for hemifacial spasm | Other | – |
Primary outcome
Samsung Medical center Grading system for Severity of Hemifacial Spasm
Time frame: one month
Success rate by assessing the degree of hemifacial spasm pre and post-operative using the SMC grading system proposed by Lee et all
Hearing Affection
Time frame: one month
Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss
Recurrence
Time frame: Six Month
Recurrence rate within the duration of follow up
Morbidity and mortality
Time frame: Six Month
Morbidity and mortality rates related to the procedure using modified Rankin Scale
1 secondary outcome
changes in facial evoked EMG
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Background: PubMed 14921388THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. No abstract available. Undetermined Language.
- Background: PubMed 20864122Wu Y, Davidson AL, Pan T, Jankovic J. Asian over-representation among patients with hemifacial spasm compared to patients with cranial-cervical dystonia. J Neurol Sci. 2010 Nov 15;298(1-2):61-3. doi: 10.1016/j.jns.2010.08.017.
- Background: PubMed 573406Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. doi: 10.1212/wnl.29.9_part_1.1261.
- Background: PubMed 29937774Cui Z, Ling Z. Advances in microvascular decompression for hemifacial spasm. J Otol. 2015 Mar;10(1):1-6. doi: 10.1016/j.joto.2015.06.002. Epub 2015 Jul 26.
- Background: PubMed 20349099Hyun SJ, Kong DS, Park K. Microvascular decompression for treating hemifacial spasm: lessons learned from a prospective study of 1,174 operations. Neurosurg Rev. 2010 Jul;33(3):325-34; discussion 334. doi: 10.1007/s10143-010-0254-9. Epub 2010 Mar 27.
- Results publication: PubMed 29454467Sindou M, Mercier P. Microvascular decompression for hemifacial spasm: Outcome on spasm and complications. A review. Neurochirurgie. 2018 May;64(2):106-116. doi: 10.1016/j.neuchi.2018.01.001. Epub 2018 Feb 15.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemifacial Spasm, run by Assiut University.
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 1 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 17 Jul 2020. 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.
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?
Samsung Medical center Grading system for Severity of Hemifacial Spasm (time frame: one month). The study lists 4 primary outcomes in all. 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 NCT04474977, 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 17 Jul 2020.