NCT04474977

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

July 14, 2020

Last Update Submit

July 16, 2020

Conditions

Hemifacial Spasm

Outcome Measures

Primary Outcomes (4)

  • 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

  • Hearing Affection

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

    one month

  • Recurrence

    Recurrence rate within the duration of follow up

    Six Month

  • Morbidity and mortality

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

    Six Month

Secondary Outcomes (1)

  • changes in facial evoked EMG

    one month

Interventions

Microvascular Decompressive SurgeryOTHER

Microvascular decompression for hemifacial spasm

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The sample size calculated by sample size calculator software according to: 1. confidence interval : 95% 2. power : 80% 3. P-value : 5% 4. Prevalence : 0.79/100000 5. Population size: 110,000 referenced by Assiut health directory statistics 2018 All cases that fulfil the selection criteria that will be admitted in the department of neurosurgery at Assiut university hospital with expected size of at least 30 patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • THUREL R. [Peripheral facial hemispasm, trigeminal neuralgia and masticatory spasm on the same side]. Rev Neurol (Paris). 1951;85(4):288-9. No abstract available. Undetermined Language.

    PMID: 14921388BACKGROUND

  • 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.

    PMID: 20864122BACKGROUND

  • Auger RG. Hemifacial spasm: clinical and electrophysiologic observations. Neurology. 1979 Sep;29(9 Pt 1):1261-72. doi: 10.1212/wnl.29.9_part_1.1261.

    PMID: 573406BACKGROUND

  • 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.

    PMID: 29937774BACKGROUND

  • 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.

    PMID: 20349099BACKGROUND

  • 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.

    PMID: 29454467RESULT

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Lecturer

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 17, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

July 17, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share