Dystonic DisorderNCT00017875
Transcranial Magnetic Stimulation (TMS) Studies of Dystonia
An observational study of Dystonic Disorder and Healthy, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use transcranial magnetic stimulation to examine how the brain controls muscle movement in focal and generalized types of dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting or abnormal postures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dystonic Disorder, Healthy
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to Jul 2005
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy Volunteers entered into the study must be free of serious somatic disease as determined by a standard physical and neurological examination.
- For patients, the only selection criteria are the presence of primary dystonia, either focal or generalized (DYT1).
- Children aged 8 years or older will be included. Gender, ethnic origin and race will not be biased for inclusion.
Who cannot join
- The exclusion criteria for this study include subjects who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than 3 months) brain lesions.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Neurophysiological Studies of Focal and Generalized Forms of Dystonia Using Transcranial Magnetic Stimulation (TMS)
This study will use transcranial magnetic stimulation to examine how the brain controls muscle movement in focal and generalized types of dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting or abnormal postures. Dystonia may be focal, involving just one region of the body, such as the hand, neck or face. Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand, generally begins in childhood or adolescence. Symptoms begin in one area and then become more widespread.
Healthy normal volunteers and patients with focal or generalized dystonia 8 years of age and older may be eligible for this study. First-degree relatives of patients will also be enrolled.
Read more
In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp and brief electrical currents are passed through the coil, creating magnetic pulses that pass into the brain. These pulses generate very small electrical currents in the cortex-the outer part of the brain-briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face and limbs. During the stimulation, the subject will be asked to either keep the hand relaxed or to slightly tense certain muscles in the hand or arm. The test will last about 1.5 hours.
The cause of dystonia is unknown. It is hoped that a comparison of brain activity in normal volunteers, patients and their relatives not affected by dystonia will help scientists learn why some people develop dystonic movements.
Read the detailed description
The objective of this study is to evaluate intracortical inhibition (ICI) in focal dystonia and in generalized dystonia of known genetic origin (DYT1 dystonia) in order to determine whether abnormalities of ICI can represent a marker of genetic predisposition for the development of dystonia. It is unclear why some carriers of the DYT1 dystonia do not develop dystonic symptoms. One possible explanation is that the development of dystonia is a two-stage process: first, loss of ICI (which may be genetically determined) and, second, exposure to an environmental trigger such as excessive repetitive movements. Thus we hypothesize that impaired ICI may serve as a marker for the DYT1 carrier state. There is good evidence that focal dystonia is a genetically determined disorder, but the gene responsible remains undetermined. We hypothesize that, in up to 50% of first degree relatives of patients with focal dystonia, impaired ICI may be found which would serve as a gene marker for the abnormality. In those individuals with this genetic marker of impaired ICI, further linkage analysis studies could be performed to identify the causative gene. In this study, we propose to measure ICI using transcranial magnetic stimulation in patients with both focal and generalized forms of dystonia, their first degree relatives and an age matched control group.
- Conditions
- Dystonic Disorder, Healthy
- Keywords
- Transcranial Magnetic Stimulation, Intracortical Inhibition, Dystonia, Focal Dystonia, Dystonic Disorder, DYTI Dystonia, Movement Disorder, Generalized Dystonia, Healthy Control, Normal Volunteer
- Medical subject headings
- Dystonic Disorders, Dystonia, Movement Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2001 (estimated)
- Study startJun 2001
- Study completionJul 2005
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 Dystonic DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017875
- Sponsor's protocol ID
- 010188
- Other IDs
- 01-N-0188
- Status last verified
- Jul 2005
- First submitted
- 15 Jun 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Hallett M. The neurophysiology of dystonia. Arch Neurol. 1998 May;55(5):601-3. doi: 10.1001/archneur.55.5.601.
PubMed 9605716Nutt JG, Muenter MD, Melton LJ 3rd, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol. 1988;50:361-5. No abstract available.
PubMed 3400496Fahn S. Concept and classification of dystonia. Adv Neurol. 1988;50:1-8. No abstract available.
PubMed 3041755
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Studies of Focal and Generalized Forms of Dystonia Using Transcranial Magnetic Stimulation (TMS)
- ClinicalTrials.gov ID
- NCT00017875
- Acronym / sponsor ID
- 010188
- Conditions
- Dystonic Disorder, Healthy
- Keywords
- Transcranial Magnetic Stimulation, Intracortical Inhibition, Dystonia, Focal Dystonia, Dystonic Disorder, DYTI Dystonia, Movement Disorder, Generalized Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 2001
- Study completion
- Jul 2005
- First posted
- 18 Jun 2001 (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 use transcranial magnetic stimulation to examine how the brain controls muscle movement in focal and generalized types of dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting or abnormal postures. Dystonia may be focal, involving just one region of the body, such as the hand, neck or face. Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand, generally begins in childhood or adolescence. Symptoms begin in one area and then become more widespread.
Healthy normal volunteers and patients with focal or generalized dystonia 8 years of age and older may be eligible for this study. First-degree relatives of patients will also be enrolled.
In transcranial magnetic stimulation, an insulated wire coil is placed on the subject's scalp and brief electrical currents are passed through the coil, creating magnetic pulses that pass into the brain. These pulses generate very small electrical currents in the cortex-the outer part of the brain-briefly disrupting the function of the brain cells in the stimulated area. The stimulation may cause muscle twitching or tingling in the scalp, face and limbs. During the stimulation, the subject will be asked to either keep the hand relaxed or to slightly tense certain muscles in the hand or arm. The test will last about 1.5 hours.
The cause of dystonia is unknown. It is hoped that a comparison of brain activity in normal volunteers, patients and their relatives not affected by dystonia will help scientists learn why some people develop dystonic movements.
Detailed description
The objective of this study is to evaluate intracortical inhibition (ICI) in focal dystonia and in generalized dystonia of known genetic origin (DYT1 dystonia) in order to determine whether abnormalities of ICI can represent a marker of genetic predisposition for the development of dystonia. It is unclear why some carriers of the DYT1 dystonia do not develop dystonic symptoms. One possible explanation is that the development of dystonia is a two-stage process: first, loss of ICI (which may be genetically determined) and, second, exposure to an environmental trigger such as excessive repetitive movements. Thus we hypothesize that impaired ICI may serve as a marker for the DYT1 carrier state. There is good evidence that focal dystonia is a genetically determined disorder, but the gene responsible remains undetermined. We hypothesize that, in up to 50% of first degree relatives of patients with focal dystonia, impaired ICI may be found which would serve as a gene marker for the abnormality. In those individuals with this genetic marker of impaired ICI, further linkage analysis studies could be performed to identify the causative gene. In this study, we propose to measure ICI using transcranial magnetic stimulation in patients with both focal and generalized forms of dystonia, their first degree relatives and an age matched control group.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy Volunteers entered into the study must be free of serious somatic disease as determined by a standard physical and neurological examination.
- For patients, the only selection criteria are the presence of primary dystonia, either focal or generalized (DYT1).
- Children aged 8 years or older will be included. Gender, ethnic origin and race will not be biased for inclusion.
Key exclusion criteria (1 listed)
- The exclusion criteria for this study include subjects who have a pacemaker, an implanted medication pump, a metal plate in the skull, metal objects inside the eye or skull (for example, after brain surgery or a shrapnel wound) or any recent (less than 3 months) brain lesions.
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 4 Mar 2008.
- Background: PubMed 9605716Hallett M. The neurophysiology of dystonia. Arch Neurol. 1998 May;55(5):601-3. doi: 10.1001/archneur.55.5.601.
- Background: PubMed 3400496Nutt JG, Muenter MD, Melton LJ 3rd, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol. 1988;50:361-5. No abstract available.
- Background: PubMed 3041755Fahn S. Concept and classification of dystonia. Adv Neurol. 1988;50:1-8. No abstract available.
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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 Dystonic Disorder and Healthy, 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 3 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: finished, as of the sponsor's last update on 4 Mar 2008. 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 NCT00017875, 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 4 Mar 2008.