NCT01726725

Brief Summary

Patients are chosen to participate in this study because they will undergo a particular type of brain surgery to treat their hemifacial spasm. This surgery is called microvascular decompression (MVD) and involves the facial nerve. The facial nerve is being compressed by one or more blood vessels and this contact produces the facial twitches. The investigators do not know why a blood vessel that touches the facial nerve produces facial twitches. The investigators are interested in investigating this during your surgery. A total of 25 participants are expected to participate in this study.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 16, 2012

Status Verified

November 1, 2012

Enrollment Period

1.1 years

First QC Date

November 7, 2012

Last Update Submit

November 15, 2012

Conditions

Hemifacial Spasm

Keywords

hemifacial spasmmicrovascular decompression surgerydesflurane

Outcome Measures

Primary Outcomes (1)

  • Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels

    one year

Study Arms (1)

hemifacial spasm, lateral spread, motor evoked potentials

EMG recordings from facial muscles of HFS patients during MVD surgery will be compared during total intravenous anesthesia (propofol), 0.5 MAC desflurane and 1.0 MAC desflurane

Drug: desflurane

Interventions

desfluraneDRUG
hemifacial spasm, lateral spread, motor evoked potentials

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery

You may qualify if:

  • patients referred to the neurosurgical service for microvascular decompression surgery for HFS
  • males and females 18 to 75 years of age
  • otherwise normal neurological exam
  • signed informed consent

You may not qualify if:

  • Botox treatment within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemifacial Spasm

Interventions

Desflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Marshall Wilkinson, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 15, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 16, 2012

Record last verified: 2012-11