Microvascular Decompressive Surgery for Hemifacial Spasm

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04474977
Collaborator
(none)
30
29.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Microvascular Decompressive Surgery

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

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Microvascular Decompressive Surgery for Hemifacial Spasm: Nuances of Technique and Outcome
Anticipated Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Samsung Medical center Grading system for Severity of Hemifacial Spasm [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

  2. Hearing Affection [one month]

    Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss

  3. Recurrence [Six Month]

    Recurrence rate within the duration of follow up

  4. Morbidity and mortality [Six Month]

    Morbidity and mortality rates related to the procedure using modified Rankin Scale

Secondary Outcome Measures

  1. changes in facial evoked EMG [one month]

    Detect the changes in facial evoked EMG preoperative and postoperative and its correlation to outcomes (esp. disappearance of lateral spread response)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Zanaty, Asisstant Lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT04474977
Other Study ID Numbers:
  • Hemifacial Spasm
First Posted:
Jul 17, 2020
Last Update Posted:
Jul 17, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2020