BlepharospasmNCT00500799
Brain Changes in Blepharospasm
An observational study of Blepharospasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharospasm
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2007to 14 Apr 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers (aged 18 or older) who are willing to participate.
- Patients (aged 18 and older) with benign essential blepharospasm
Who cannot join
- Subjects with a history of neurological or psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy.
- Subjects receiving drugs acting primarily on the central nervous system
- Subjects with a history of neurological disorders other than blepharospasm
- Subjects with a history of a psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy.
- Subjects receiving drugs acting primarily on the central nervous system
- Subjects who have been treated with botulinum toxin injections within 3 months prior to their participation in the study
Show all 16Show fewer
- Subjects who are taking any medication for dystonia at the time of the study
- Subjects with severe forceful closure of eyelids, subjects scoring more than 20 on the Blepharospasm Disability scale (Lindeboom et al., 1995).
- Patients for whom participation in the study would, in the opinion of the investigators, cause undue stress or excessive apprehensiveness will also be excluded. The reason for that is that, in some patients, any stressful situation (like a medical exam or experiment) may cause a strong increase in the involuntary blink rate leading to a severe functional discomfort.
- The following exclusion criteria are due to the use of transcranial magnetic stimulation and repetitive transcranial magnetic stimulation up to 1Hz (Hallett 1999) for healthy volunteers and patients:
- Subjects with cardiac pacemakers, intracardiac lines, implanted medication pumps.
- Subjects with eye, blood vessel, cochlear, or eye implants.
- Subjects with increased intracranial pressure as evaluated by clinical means
- Subjects with metal in the cranium
- Subjects with dental braces (but dental fillings are not a problem), metal fragments from occupational exposure or surgical clips in or near the brain.
- Subjects with a personal or family history of hearing loss
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Role of the Cortical Medial Frontal Areas in Blepharospasm
This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia.
Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study. All candidates are screened with a medical history. People with blepharospasm also have a physical examination and blepharospasm rating.
Read more
Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in two 4-hour sessions, separated by 1 to 7 days.
TMS
A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.
EMG
Surface EMG is done during TMS to measure the electrical activity of muscles. For this test, electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the face....
Read the detailed description
Objectives
This proposal will evaluate the role of an increase in excitability of the orbicularis oculi (OO) muscle representation in the medial frontal areas (supplementary motor areas, SMA) and anterior rostral cingulate: M3) in excessive blinking in patients with benign essential blepharospasm (BEB). We hypothesize that:
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS, targeting the SMA-M3, is more prominent in patients with BEP than in healthy control subjects,
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1, is almost the same in patients with BEP and in healthy control subjects,
- at rest, sICI of OO muscle will be decreased and ICF increased after stimulation of the SMA-M3 facial cortical area, in patients with BEP compared to healthy control subjects,
- at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1 facial area in patients with BEP and healthy control subjects,
- in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent during voluntary blinking,
- in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent during involuntary blinking,
- in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during voluntary and involuntary blinking.
- it is possible to evoke consistent and reproducible motor evoked responses (MEP) in the orbicularis oculi (OO) muscles by stimulating the two main cortical representations of upper facial region: in the medial frontal wall (SMA and cingulate cortex - its rostral part, M3) and in the primary motor cortex (M1) with transcranial magnetic stimulation (TMS).
Study population
36 patients with BEB but without severe forceful closure of eyelids, 36 normal volunteers.
Study design
Subjects will have 3 visits:
Visit 1: screening and blepharospasm score
Visit 2: stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS (1Hz) with the Hesed coil (designed to stimulate deep brain).
Visit 3: stimulation of the OO muscle representation in M1 using low frequency rTMS (1Hz) using a standard eight-shaped coil.
Visits 2 and 3: single pulse TMS will be used to evoke MEPs from OO muscles. Paired pulse TMS will be used to assess sICI from OO muscles. The order of visits 2 and 3 will be randomly assigned.
Outcome measures
The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed before and after 15 minutes of low frequency rTMS. The secondary outcome measures will be the sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks.
- Conditions
- Blepharospasm
- Keywords
- Transcranial Magnetic Stimulation (TMS), Blink Reflex, Blepharospasm, Healthy Volunteer, HV
- Medical subject headings
- Blepharospasm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study start9 Jul 2007
- Study completion14 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BlepharospasmStudies 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
- Time perspective
- Prospective
- Enrolment
- 72 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500799
- Sponsor's protocol ID
- 070191
- Other IDs
- 07-N-0191
- Status last verified
- 14 Apr 2009
- First submitted
- 12 Jul 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Baker RS, Andersen AH, Morecraft RJ, Smith CD. A functional magnetic resonance imaging study in patients with benign essential blepharospasm. J Neuroophthalmol. 2003 Mar;23(1):11-5. doi: 10.1097/00041327-200303000-00003.
PubMed 12616082Cunnington R, Iansek R, Thickbroom GW, Laing BA, Mastaglia FL, Bradshaw JL, Phillips JG. Effects of magnetic stimulation over supplementary motor area on movement in Parkinson's disease. Brain. 1996 Jun;119 ( Pt 3):815-22. doi: 10.1093/brain/119.3.815.
PubMed 8673493Gerschlager W, Siebner HR, Rothwell JC. Decreased corticospinal excitability after subthreshold 1 Hz rTMS over lateral premotor cortex. Neurology. 2001 Aug 14;57(3):449-55. doi: 10.1212/wnl.57.3.449.
PubMed 11502912
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Cortical Medial Frontal Areas in Blepharospasm
- ClinicalTrials.gov ID
- NCT00500799
- Acronym / sponsor ID
- 070191
- Conditions
- Blepharospasm
- Keywords
- Transcranial Magnetic Stimulation (TMS), Blink Reflex, Blepharospasm, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Jul 2007
- Study completion
- 14 Apr 2009
- First posted
- 13 Jul 2007 (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.
This study will examine the role of certain areas of the brain in blepharospasm, a type of dystonia (abnormality of movement and muscle tone) that causes unwanted or uncontrollable blinking or closing of the eyelids. The study will compare brain activity in healthy volunteers and in people with blepharospasm to find differences in the brain that may lead to better treatments for dystonia.
Healthy volunteers and people with blepharospasm who are 18 years of age and older may be eligible for this study. All candidates are screened with a medical history. People with blepharospasm also have a physical examination and blepharospasm rating.
Participants undergo transcranial magnetic stimulation (TMS) and electromyography (EMG) in two 4-hour sessions, separated by 1 to 7 days.
TMS
A wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in muscles of the face, arm or leg. During the stimulation, subjects may be asked to tense certain muscles slightly or perform other simple actions. Repetitive TMS involves repeated magnetic pulses delivered in short bursts of impulses. Subjects receive 60 pulses per minute over 15 minutes.
EMG
Surface EMG is done during TMS to measure the electrical activity of muscles. For this test, electrodes (small metal disks) are filled with a conductive gel and taped to the skin of the face....
Detailed description
Objectives
This proposal will evaluate the role of an increase in excitability of the orbicularis oculi (OO) muscle representation in the medial frontal areas (supplementary motor areas, SMA) and anterior rostral cingulate: M3) in excessive blinking in patients with benign essential blepharospasm (BEB). We hypothesize that:
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS, targeting the SMA-M3, is more prominent in patients with BEP than in healthy control subjects,
- at rest, the decrease of the MEP after 15 minutes of 1Hz rTMS targeting M1, is almost the same in patients with BEP and in healthy control subjects,
- at rest, sICI of OO muscle will be decreased and ICF increased after stimulation of the SMA-M3 facial cortical area, in patients with BEP compared to healthy control subjects,
- at rest sICI and ICF of the OO muscle will be the same after stimulation of the M1 facial area in patients with BEP and healthy control subjects,
- in healthy control subjects facilitation of the MEPs evoked from M1 is more prominent during voluntary blinking,
- in healthy control subjects facilitation of the MEP evoked from SMA-M3 is more prominent during involuntary blinking,
- in patients with BEB there is facilitation of MEPs evoked from M1 and SMA-M3 during voluntary and involuntary blinking.
- it is possible to evoke consistent and reproducible motor evoked responses (MEP) in the orbicularis oculi (OO) muscles by stimulating the two main cortical representations of upper facial region: in the medial frontal wall (SMA and cingulate cortex - its rostral part, M3) and in the primary motor cortex (M1) with transcranial magnetic stimulation (TMS).
Study population
36 patients with BEB but without severe forceful closure of eyelids, 36 normal volunteers.
Study design
Subjects will have 3 visits:
Visit 1: screening and blepharospasm score
Visit 2: stimulation of the OO muscle representation in SMA-M3 using low frequency rTMS (1Hz) with the Hesed coil (designed to stimulate deep brain).
Visit 3: stimulation of the OO muscle representation in M1 using low frequency rTMS (1Hz) using a standard eight-shaped coil.
Visits 2 and 3: single pulse TMS will be used to evoke MEPs from OO muscles. Paired pulse TMS will be used to assess sICI from OO muscles. The order of visits 2 and 3 will be randomly assigned.
Outcome measures
The main outcome measures will be the sizes of OO muscle MEPs and the amount of sICI assessed before and after 15 minutes of low frequency rTMS. The secondary outcome measures will be the sizes of OO muscle MEPs assessed before and during voluntary and involuntary blinks.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers (aged 18 or older) who are willing to participate.
- Patients (aged 18 and older) with benign essential blepharospasm
Key exclusion criteria (16 listed)
- Subjects with a history of neurological or psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy.
- Subjects receiving drugs acting primarily on the central nervous system
- Subjects with a history of neurological disorders other than blepharospasm
- Subjects with a history of a psychiatric disorder, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization or prolonged treatment, head injury with loss of consciousness, or epilepsy.
- Subjects receiving drugs acting primarily on the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12616082Baker RS, Andersen AH, Morecraft RJ, Smith CD. A functional magnetic resonance imaging study in patients with benign essential blepharospasm. J Neuroophthalmol. 2003 Mar;23(1):11-5. doi: 10.1097/00041327-200303000-00003.
- Background: PubMed 8673493Cunnington R, Iansek R, Thickbroom GW, Laing BA, Mastaglia FL, Bradshaw JL, Phillips JG. Effects of magnetic stimulation over supplementary motor area on movement in Parkinson's disease. Brain. 1996 Jun;119 ( Pt 3):815-22. doi: 10.1093/brain/119.3.815.
- Background: PubMed 11502912Gerschlager W, Siebner HR, Rothwell JC. Decreased corticospinal excitability after subthreshold 1 Hz rTMS over lateral premotor cortex. Neurology. 2001 Aug 14;57(3):449-55. doi: 10.1212/wnl.57.3.449.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blepharospasm, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 2 inclusion and 16 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: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00500799, which also lists 3 linked publications.
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 2 Jul 2017.