DystoniaNCT00487383
Brain Changes in Blepharospasm
An observational study of Dystonia and Focal Dystonia, 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 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Focal Dystonia, Cerebellar Disease
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2007to 29 Jun 2012
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS:
- Age 18 years or older
- Normal findings in the medical history, physical and neurological examination, except for dystonia
- HEALTHY CONTROLS:
- Age 18 years or older
- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
Who cannot join
- Any of the following will exclude patients and controls from the study:
- Secondary forms of dystonia, including tardive dyskinesia
- History of seizure disorder
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications, anti-seizure medications, anticholinergic drugs, and muscle relaxants
- Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- History of neuroleptic medications
Show all 9Show fewer
- Presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye
- Botulinum toxin injection within 3 months of starting the protocol
- Known 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: Suppression and Facilitation of the Motor Cortex by Stimulation of the Cerebellum in Patients With Dystonia and Healthy Controls
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
Objective
Besides alterations in the basal ganglia, substantial evidence identifies cerebellar dysfunction as a possible cause for dystonia. Pathophysiological findings suggest that the cerebellar influence on the primary motor cortex is modified in patients with different forms of dystonia. The objective of this study is to find out whether this cerebellar influence plays a role in dystonic disorders.
Study population
20 patients with blepharospasm, 20 patients with focal hand dystonia, 20 patients with DYT-1 Primary generalized dystonia and 60 healthy volunteers age and sex matched.
Design
Paired pulse transcranial magnetic stimulation (TMS) will be performed at rest and during tonic activation of the first dorsal interosseus muscle (FDI). The conditioning stimulus (CS) will be applied to the ipsilateral cerebellum using different intensities and will precede the test stimulus by intervals from 3 to 10 ms, respectively. The test stimulus (TS) will be applied over the motor hot spot of FDI in the primary motor cortex.
Outcome measures
The primary outcome measure will be the motor evoked potential (MEP) in FDI after a conditioning cerebellar stimulus in relation to the unconditioned MEP size. Each different patient group will be compared separately to the age- and sex-matched healthy controls and between each other. Secondary outcome parameters will be the influence of different interstimulus intervals and different stimulation intensities of the conditioning stimulus on the MEP.
- Conditions
- Dystonia, Focal Dystonia, Cerebellar Disease
- Keywords
- Cerebellum, Transcranial Magnetic Stimulation (TMS), Blepharospasm, DYT-1 Generalized Dystonia, Focal Dystonia, Dystonia, Healthy Volunteer, HV
- Medical subject headings
- Dystonia, Dystonic Disorders, Cerebellar Diseases, Blepharospasm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study start12 Jun 2007
- Study completion29 Jun 2012
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 DystoniaStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487383
- Sponsor's protocol ID
- 070165
- Other IDs
- 07-N-0165
- Status last verified
- 29 Jun 2012
- First submitted
- 15 Jun 2007
- Last updated
- 16 Dec 2019
- Results posted
- No
Publications
Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Sole J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433-44. doi: 10.1111/j.1468-1331.2006.01537.x.
PubMed 16722965Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. doi: 10.1016/s0140-6736(05)71235-6. No abstract available.
PubMed 11254003Aramideh M, Ongerboer de Visser BW, Holstege G, Majoie CB, Speelman JD. Blepharospasm in association with a lower pontine lesion. Neurology. 1996 Feb;46(2):476-8. doi: 10.1212/wnl.46.2.476.
PubMed 8614517
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression and Facilitation of the Motor Cortex by Stimulation of the Cerebellum in Patients With Dystonia and Healthy Controls
- ClinicalTrials.gov ID
- NCT00487383
- Acronym / sponsor ID
- 070165
- Conditions
- Dystonia, Focal Dystonia, Cerebellar Disease
- Keywords
- Cerebellum, Transcranial Magnetic Stimulation (TMS), Blepharospasm, DYT-1 Generalized Dystonia, Focal Dystonia, Dystonia, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 12 Jun 2007
- Study completion
- 29 Jun 2012
- First posted
- 18 Jun 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
Objective
Besides alterations in the basal ganglia, substantial evidence identifies cerebellar dysfunction as a possible cause for dystonia. Pathophysiological findings suggest that the cerebellar influence on the primary motor cortex is modified in patients with different forms of dystonia. The objective of this study is to find out whether this cerebellar influence plays a role in dystonic disorders.
Study population
20 patients with blepharospasm, 20 patients with focal hand dystonia, 20 patients with DYT-1 Primary generalized dystonia and 60 healthy volunteers age and sex matched.
Design
Paired pulse transcranial magnetic stimulation (TMS) will be performed at rest and during tonic activation of the first dorsal interosseus muscle (FDI). The conditioning stimulus (CS) will be applied to the ipsilateral cerebellum using different intensities and will precede the test stimulus by intervals from 3 to 10 ms, respectively. The test stimulus (TS) will be applied over the motor hot spot of FDI in the primary motor cortex.
Outcome measures
The primary outcome measure will be the motor evoked potential (MEP) in FDI after a conditioning cerebellar stimulus in relation to the unconditioned MEP size. Each different patient group will be compared separately to the age- and sex-matched healthy controls and between each other. Secondary outcome parameters will be the influence of different interstimulus intervals and different stimulation intensities of the conditioning stimulus on the MEP.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Normal findings in the medical history, physical and neurological examination, except for dystonia
- Age 18 years or older
- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems
Key exclusion criteria (9 listed)
- Secondary forms of dystonia, including tardive dyskinesia
- History of seizure disorder
- Symptoms of a clinically relevant illness in the 2 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants, neuroleptic medications, anti-seizure medications, anticholinergic drugs, and muscle relaxants
- Taking the following medications: antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
- History of neuroleptic medications
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Background: PubMed 16722965Albanese A, Barnes MP, Bhatia KP, Fernandez-Alvarez E, Filippini G, Gasser T, Krauss JK, Newton A, Rektor I, Savoiardo M, Valls-Sole J. A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task Force. Eur J Neurol. 2006 May;13(5):433-44. doi: 10.1111/j.1468-1331.2006.01537.x.
- Background: PubMed 11254003Aramideh M, Koelman JH, Speelman JD, Ongerboer de Visser B. Eyelid movement disorders and electromyography. Lancet. 2001 Mar 10;357(9258):805-6. doi: 10.1016/s0140-6736(05)71235-6. No abstract available.
- Background: PubMed 8614517Aramideh M, Ongerboer de Visser BW, Holstege G, Majoie CB, Speelman JD. Blepharospasm in association with a lower pontine lesion. Neurology. 1996 Feb;46(2):476-8. doi: 10.1212/wnl.46.2.476.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Dystonia and Focal Dystonia, 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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Dec 2019. 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 was stopped early. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00487383, 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 16 Dec 2019.