Hemifacial SpasmHFSNCT01726725
Hemifacial Spasm and Desflurane
An observational study of Hemifacial Spasm, run by University of Manitoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemifacial Spasm
- What is being tested?
- desflurane
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery
Who may be able to join
- 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
Who cannot join
- Botox treatment within the last three months
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemifacial Spasm
- Being tested
- desflurane
- Keywords
- hemifacial spasm, microvascular decompression surgery, desflurane
- Medical subject headings
- Hemifacial Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desfluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemifacial SpasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marshall Wilkinson, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726725
- Sponsor's protocol ID
- B2012:099
- Acronym
- HFS
- Status last verified
- Nov 2012
- First submitted
- 7 Nov 2012
- Last updated
- 16 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Etiology of Hemifacial Spasm (HFS): The Role of Desflurane
- ClinicalTrials.gov ID
- NCT01726725
- Acronym / sponsor ID
- HFS / B2012:099
- Conditions
- Hemifacial Spasm
- Keywords
- hemifacial spasm, microvascular decompression surgery, desflurane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemifacial spasm, lateral spread, motor evoked potentials | – | Drug: desfluraneEMG 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with hemifacial spasm who will be undergoing microvascular decompression surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Botox treatment within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desflurane | Drug | hemifacial spasm, lateral spread, motor evoked potentials |
Primary outcome
Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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Prospective Register Study to Assess Eligibility for and Efficacy of Surgical Treatment in Patients With nEuRovascular Conflict
Trigeminal Neuralgia, Tic Douloureux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall Wilkinson, PhD principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
An observational study of Hemifacial Spasm, run by University of Manitoba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure EMG responses to peripheral nerve stimulation and motor cortex stimulation during changes in desflurane levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2012.