Hemifacial Spasm and Desflurane (HFS)

November 15, 2012 updated by: University of Manitoba

Investigating the Etiology of Hemifacial Spasm (HFS): The Role of Desflurane

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

"Intra Operative Monitoring" (IOM) is a standard and routine medical practice for patients having MVD surgery. IOM is done to make sure that the hearing and face nerves are not accidentally bumped or damaged during surgery. After anesthetic induction, the neurophysiologist places electrodes for the nerves, on the scalp and muscles. Stimulation and monitoring of muscle twitches are all common, safe and painless medical procedures.

In this study, the investigators would like to measure the nerve and muscle function on the normal side and compare it to nerve and muscle function on the abnormal side during different levels of the anesthetic desflurane. In order to monitor the normal side of the face one additional set of electrodes will be placed in the facial muscles. The investigators will compare responses to three different levels of anesthetic. The technique used will be motor evoked potentials. The effect of the anesthesia on the lateral spread response will also be examined. This response is evident only on the symptomatic side. These observations will take approximately 10 to 15 minutes and will not delay or lengthen the surgery.

Study Type

Observational

Enrollment (Anticipated)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Botox treatment within the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Marshall Wilkinson, PhD, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (ESTIMATE)

November 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2012:099

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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