Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04474977
Other study ID # Hemifacial Spasm
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 1, 2023

Study information

Verified date July 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 1, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

Primary Hemi facial spasm Unilateral Adults 20-60 years Clinical Diagnosis confirmed by Facial Evoked potential & Neuroimaging

Exclusion Criteria:

Secondary Hemi facial spasm caused by intracranial masses or other lesions Recurrent Hemi facial spasm Patients who are unfit for any neurosurgical interventions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Microvascular Decompressive Surgery
Microvascular decompression for hemifacial spasm

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. — View Citation

Cui 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. — View Citation

Hyun 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. — View Citation

Sindou 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. Review. — View Citation

THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. Undetermined Language. — View Citation

Wu 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one month
Primary Hearing Affection Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss one month
Primary Recurrence Recurrence rate within the duration of follow up Six Month
Primary Morbidity and mortality Morbidity and mortality rates related to the procedure using modified Rankin Scale Six Month
Secondary 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) one month
See also
  Status Clinical Trial Phase
Withdrawn NCT01932255 - CSF Leak Following Microvascular Decompression: the Benefit of Routine Postoperative Lumbar Tap N/A
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Recruiting NCT03306940 - Botulinum Toxin A in the Treatment of Hemifacial Spasm N/A
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Unknown status NCT01726725 - Hemifacial Spasm and Desflurane N/A
Completed NCT01598961 - Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery N/A
Not yet recruiting NCT04589364 - Study of Abobotulinum Toxin Versus Neubotulinum Toxin Injection For Hemifacial Spasm in Thai Patients Phase 3
Completed NCT01613781 - Determination of Target of Adequate Partial Neuromuscular Blockade for Electrophysiologic Monitoring During Microvascular Decompression Surgery N/A
Not yet recruiting NCT06195241 - Effects of DaxibotulinumtoxinA for Blepharospasm and Hemifacial Spasm Phase 4
Completed NCT03508882 - Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm Phase 4
Enrolling by invitation NCT01271634 - Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients N/A
Recruiting NCT04645277 - Magnetic Resonance Imaging Study on Patients With Hemifacial Spasm
Completed NCT03390803 - Effect of Hemifacial Spasm on Intraocular Pressure Measurement N/A
Completed NCT01728428 - A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients N/A
Completed NCT04621578 - Transcutaneous Electrical Acupoint Stimulation on Postoperative Dizziness in Hemifacial Spasm Patients N/A
Completed NCT00276315 - Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm Phase 3
Completed NCT02761096 - Effect of Acupuncture on Inflammation and Immune Function After Craniotomy N/A
Not yet recruiting NCT01546805 - Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm N/A
Unknown status NCT01564979 - Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm Phase 2
Completed NCT01168388 - Movement Disorder Survey in East China N/A