Hemifacial Spasm Clinical Trial
Official title:
Microvascular Decompressive Surgery for Hemifacial Spasm: Nuances of Technique and Outcome
Verified date | July 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
- 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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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
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 |
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