Hemifacial SpasmMRI-HFSNCT04645277
Magnetic Resonance Imaging Study on Patients With Hemifacial Spasm
An observational study of Hemifacial Spasm and Magnetic Resonance Imaging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with hemifacial spasm (HFS). However, due to lack of stereoscopic vision, this traditional method sometimes can not meet the requirement on identifying the details of NVC, especially when the… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemifacial Spasm, Magnetic Resonance Imaging
- What is being tested?
- Scanning with magnetic resonance imaging
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Dec 2024
- How long will I take part?
- 3 Years
- 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: Primary hemifacial spasm patients, the typical symptoms are unilateral, involuntary, and intermittent contractions of facial muscles innervated by the ipsilateral facial nerve.
Who may be able to join
- Primary HFS patients according to medical history and typical facial muscle spasms that are unilateral, involuntary, and had intermittent contractions innervated by the ipsilateral facial nerve. The patient has 1 year disease duration at least.
Who cannot join
- Secondary causes of HFS, such as tumors or cysts compressing the facial nerve in the cerebellar pontine cistern; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yuan Wang, M.D., 0086-13324598144, wangyuan8003@126.com
Chenguang Guo, M.D., 0086-15591877956, xiaoguo79@qq.com
About this study
Official title: Clinical Research on Patients With Hemifacial Spasm by Multi-planar Reconstruction, Curved Planar Reconstruction and Magnetic Resonance Virtual Endoscopy
Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with hemifacial spasm (HFS). However, due to lack of stereoscopic vision, this traditional method sometimes can not meet the requirement on identifying the details of NVC, especially when the aberrant vessels turn out to be veins not arteries. The three dimensional analytic techniques, such as curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic views, so as to assist the design of the surgical plan.
Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve may correlate with the severity of facial spasm due to atrophy of the nerve in most cases of HFS, and is likely secondary to the micro-structural abnormalities, such as axonal loss, demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume (V) of the cisternal facial nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of HFS.
- Conditions
- Hemifacial Spasm, Magnetic Resonance Imaging
- Being tested
- Scanning with magnetic resonance imaging
- Keywords
- Curved Planar Reconstruction, Magnetic Resonance Virtual Endoscopy
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanning with magnetic resonance imagingDevice
Facial nerves and adjacent blood vessels are scanned using MRI in the patients with hemifacial spasm (HFS). Then multiplanar reconstruction (two dimensional), along with curved planar reconstruction and magnetic resonance virtual endoscopy (three dimensional), will be performed in the different groups of HFS.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MRI using two dimensional reconstruction | Not described Receives: Device: Scanning with magnetic resonance imaging | |
| Patients with MRI using three dimensional reconstruction | Not described Receives: Device: Scanning with magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings
Severity of neurovascular compression, which will be judged by MPR, is defined as follows: 1 = no compression; 2 = contact by a vessel; 3 = indentation by a vessel; and 4 = nerve displacement or distortion by a vessel, and the results of MPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
Measured: 2021.1-2023.1
Sensitivity and Specificity of Detection of Neurovascular Compression by Curved Planar Reconstruction (CPR) Compared with Surgical Findings
Severity of neurovascular compression, which will be judged by CPR, is the same criterion as that in the Outcome 1, and the results of CPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
Measured: 2021.1-2023.1
Sensitivity and Specificity of Detection of Neurovascular Compression by Magnetic Resonance Virtual Endoscopy (MRVE) Compared with Surgical Findings
Severity of neurovascular compression, which will be judged by MRVE, is the same criterion as that in the Outcome 1, and the results of MRVE need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
Measured: 2021.1-2023.1
Secondary outcomes (2)
Change of Facial Nerve Volume (V) from Baseline to 3 years later
Baseline V (mm3) refers to the volume of the cisternal facial nerve prior to the surgical treatment. Meanwhile, the study endpoint is 3 years after the operation, which need another measurement of V.
Measurements of V will be performed using Medical Image Processing, Analysis, and Visualization software (MIPAV, http://mipav.cit.nih.gov/). The measurements start from the point where the nerves enter the pons to an imaginary demarcation made at the entrance of the nerves into internal acoustic meatus. The facial nerves are manually delineated in each traverse section. The V will be automatically calculated with the MIPAV software.
Measured: 2021.1-2024.1
Change of Facial Nerve Cross Sectional Area (CSA) from Baseline to 3 years later
Baseline CSA (mm2) refers to the cross sectional area of the cisternal facial nerve prior to the surgical treatment. Meanwhile, the study endpoint is 3 years after the operation, which need another measurement of CSA.
The CSA is calculated at 5 mm from the entry of the facial nerve into the pons in an image plane perfectly perpendicular to the course of each nerve, which also need using a mouse-driven cursor in MIPAV software.
Measured: 2021.1-2024.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Jan 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 First Affiliated Hospital Xi'an Jiaotong 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Zhang, M.D. & Ph.D., Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645277
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-017
- Acronym
- MRI-HFS
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Haller S, Etienne L, Kovari E, Varoquaux AD, Urbach H, Becker M. Imaging of Neurovascular Compression Syndromes: Trigeminal Neuralgia, Hemifacial Spasm, Vestibular Paroxysmia, and Glossopharyngeal Neuralgia. AJNR Am J Neuroradiol. 2016 Aug;37(8):1384-92. doi: 10.3174/ajnr.A4683. Epub 2016 Feb 18.
PubMed 26892985Zhang P, Selim MH, Wang H, Kuang W, Wu M, Ji C, Hu G, Wu L, Zhu X, Guo H. Intraoperative Measuring of the Offending Vessel's Pressure on the Facial Nerve at Root Exit Zone in Patients with Hemifacial Spasm During Microvascular Decompression: A Prospective Study. World Neurosurg. 2019 Feb;122:e89-e95. doi: 10.1016/j.wneu.2018.09.080. Epub 2018 Sep 25.
PubMed 30261393Naraghi R, Tanrikulu L, Troescher-Weber R, Bischoff B, Hecht M, Buchfelder M, Hastreiter P. Classification of neurovascular compression in typical hemifacial spasm: three-dimensional visualization of the facial and the vestibulocochlear nerves. J Neurosurg. 2007 Dec;107(6):1154-63. doi: 10.3171/JNS-07/12/1154.
PubMed 18077953Takao T, Oishi M, Fukuda M, Ishida G, Sato M, Fujii Y. Three-dimensional visualization of neurovascular compression: presurgical use of virtual endoscopy created from magnetic resonance imaging. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS139-45; discussion ONS145-6. doi: 10.1227/01.neu.0000335028.77779.7c.
PubMed 18728591
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Patients With Hemifacial Spasm by Multi-planar Reconstruction, Curved Planar Reconstruction and Magnetic Resonance Virtual Endoscopy
- ClinicalTrials.gov ID
- NCT04645277
- Acronym / sponsor ID
- MRI-HFS / XJTU1AF-CRF-2020-017
- Conditions
- Hemifacial Spasm, Magnetic Resonance Imaging
- Keywords
- Curved Planar Reconstruction, Magnetic Resonance Virtual Endoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Nov 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.
Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with hemifacial spasm (HFS). However, due to lack of stereoscopic vision, this traditional method sometimes can not meet the requirement on identifying the details of NVC, especially when the aberrant vessels turn out to be veins not arteries. The three dimensional analytic techniques, such as curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic views, so as to assist the design of the surgical plan.
Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve may correlate with the severity of facial spasm due to atrophy of the nerve in most cases of HFS, and is likely secondary to the micro-structural abnormalities, such as axonal loss, demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume (V) of the cisternal facial nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of HFS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MRI using two dimensional reconstruction | – | Device: Scanning with magnetic resonance imaging |
| Patients with MRI using three dimensional reconstruction | – | Device: Scanning with magnetic resonance imaging |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary hemifacial spasm patients, the typical symptoms are unilateral, involuntary, and intermittent contractions of facial muscles innervated by the ipsilateral facial nerve.
Key inclusion criteria (1 listed)
- Primary HFS patients according to medical history and typical facial muscle spasms that are unilateral, involuntary, and had intermittent contractions innervated by the ipsilateral facial nerve. The patient has 1 year disease duration at least.
Key exclusion criteria (1 listed)
- Secondary causes of HFS, such as tumors or cysts compressing the facial nerve in the cerebellar pontine cistern; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.
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 |
|---|---|---|
| Scanning with magnetic resonance imagingFacial nerves and adjacent blood vessels are scanned using MRI in the patients with hemifacial spasm (HFS). Then multiplanar reconstruction (two dimensional), along with curved planar reconstruction and magnetic resonance virtual endoscopy (three dimensional), will be performed in the different groups of HFS. | Device | Patients with MRI using three dimensional reconstruction, Patients with MRI using two dimensional reconstruction |
Primary outcome
Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings
Time frame: 2021.1-2023.1
Severity of neurovascular compression, which will be judged by MPR, is defined as follows: 1 = no compression; 2 = contact by a vessel; 3 = indentation by a vessel; and 4 = nerve displacement or distortion by a vessel, and the results of MPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
Sensitivity and Specificity of Detection of Neurovascular Compression by Curved Planar Reconstruction (CPR) Compared with Surgical Findings
Time frame: 2021.1-2023.1
Severity of neurovascular compression, which will be judged by CPR, is the same criterion as that in the Outcome 1, and the results of CPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
Sensitivity and Specificity of Detection of Neurovascular Compression by Magnetic Resonance Virtual Endoscopy (MRVE) Compared with Surgical Findings
Time frame: 2021.1-2023.1
Severity of neurovascular compression, which will be judged by MRVE, is the same criterion as that in the Outcome 1, and the results of MRVE need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.
2 secondary outcomes
Change of Facial Nerve Volume (V) from Baseline to 3 years later
Time frame: 2021.1-2024.1
Change of Facial Nerve Cross Sectional Area (CSA) from Baseline to 3 years later
Time frame: 2021.1-2024.1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 26892985Haller S, Etienne L, Kovari E, Varoquaux AD, Urbach H, Becker M. Imaging of Neurovascular Compression Syndromes: Trigeminal Neuralgia, Hemifacial Spasm, Vestibular Paroxysmia, and Glossopharyngeal Neuralgia. AJNR Am J Neuroradiol. 2016 Aug;37(8):1384-92. doi: 10.3174/ajnr.A4683. Epub 2016 Feb 18.
- Results publication: PubMed 30261393Zhang P, Selim MH, Wang H, Kuang W, Wu M, Ji C, Hu G, Wu L, Zhu X, Guo H. Intraoperative Measuring of the Offending Vessel's Pressure on the Facial Nerve at Root Exit Zone in Patients with Hemifacial Spasm During Microvascular Decompression: A Prospective Study. World Neurosurg. 2019 Feb;122:e89-e95. doi: 10.1016/j.wneu.2018.09.080. Epub 2018 Sep 25.
- Results publication: PubMed 18077953Naraghi R, Tanrikulu L, Troescher-Weber R, Bischoff B, Hecht M, Buchfelder M, Hastreiter P. Classification of neurovascular compression in typical hemifacial spasm: three-dimensional visualization of the facial and the vestibulocochlear nerves. J Neurosurg. 2007 Dec;107(6):1154-63. doi: 10.3171/JNS-07/12/1154.
- Results publication: PubMed 18728591Takao T, Oishi M, Fukuda M, Ishida G, Sato M, Fujii Y. Three-dimensional visualization of neurovascular compression: presurgical use of virtual endoscopy created from magnetic resonance imaging. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS139-45; discussion ONS145-6. doi: 10.1227/01.neu.0000335028.77779.7c.
- Individual participant dataSharing planned: Yes
Related trials for Hemifacial Spasm
RecruitingPhase 4
Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm
Benign Essential Blepharospasm, Hemifacial Spasm
Not yet recruitingObservational study
Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
Trigeminal Neuralgia, Tic Douloureux
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.
Ming Zhang, M.D. & Ph.D. principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemifacial Spasm and Magnetic Resonance Imaging, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 26 Feb 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 China. 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 Yuan Wang, M.D. (0086-13324598144, wangyuan8003@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings (time frame: 2021.1-2023.1). The study lists 3 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 NCT04645277, which also lists 4 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 26 Feb 2024.