An observational study in Hemifacial Spasm, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by Assiut University · Observational
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.
23 studies on the registry are indexed under Hemifacial Spasm; 3 are open to participants now.
This study's planned enrollment of 30 is below the median of 105 across 11 observational studies indexed under Hemifacial Spasm.
Browse Hemifacial Spasm studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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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.
Microvascular decompression for hemifacial spasm
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
Time frame: one month
Hearing Affection
Audiometry: to detect the degree of post-operative hearing affection using WHO Grading system For Hearing Loss
Time frame: one month
Recurrence
Recurrence rate within the duration of follow up
Time frame: Six Month
Morbidity and mortality
Morbidity and mortality rates related to the procedure using modified Rankin Scale
Time frame: Six Month
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)
Time frame: one month
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2020; primary completion for Sep 2022, 24 months later.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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