Dystonic DisordersNCT00029601
Surround Inhibition in Patients With Dystonia
An observational study of Dystonic Disorders 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 (TMS) to examine how the brain controls muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting and repetitive movement or abnormal postures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dystonic Disorders, Healthy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jul 2002
- 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
Healthy volunteers entering the study must be free of serious somatic disease.
Patients must have focal dystonia.
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, will be excluded.
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: The Study of Surround Inhibition in Patients With Dystonia
This study will use transcranial magnetic stimulation (TMS) to examine how the brain controls muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting and repetitive movement 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 [between 21 and 65 years of age] may be eligible for this study.
Read more
Participants will have transcranial magnetic stimulation. For this test, subjects are seated in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or transient tingling in the forearm, head or face muscles.) During the stimulation, subjects will be asked to either keep their hand relaxed or move a certain part of the hand in response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation.
There are three parts to the study, each lasting 2-3 hours and each performed on a separate day.
Read the detailed description
The purpose of this study is to evaluate modulation of inhibition within the motor cortex before and during movement in patients with focal dystonia. For a selective movement or task, certain muscles are normally recruited and others are inhibited at the cortical level. We hypothesize that a disturbance in this cortical inhibitory control could result in a failure to focus the desired motor action within the motor cortex (disturbed center surround inhibition) and may account for co-contraction of antagonist muscles and overflow into extraneous muscles in dystonic patients. Intracortical inhibition (ICI) and silent period (SP) are two major cortical inhibitory mechanisms demonstrated by transcranial magnetic stimulation (TMS). Alteration in these inhibitory mechanisms have been studied in dystonia at rest, however, as dystonic symptoms mainly occur with selective tasks or movements we plan to study intracortical inhibitory mechanisms before and during movement using different TMS paradigms.
- Conditions
- Dystonic Disorders, Healthy
- Keywords
- Magnetic Stimulation, Intracortical Inhibition, Intracortical Facilitation, Motor Evoked Potential, Reaction Time, Transcranial Magnetic Stimulation, Dystonia, Focal Dystonia, Healthy Volunteer, HV, Normal Control
- Medical subject headings
- Dystonic Disorders, Dystonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2002 (estimated)
- Study startJan 2002
- Study completionJul 2002
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 DisordersStudies 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
- 60 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029601
- Sponsor's protocol ID
- 020088
- Other IDs
- 02-N-0088
- Status last verified
- Jul 2002
- First submitted
- 15 Jan 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Nutt 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 3400496Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
PubMed 1695401Hoover JE, Strick PL. Multiple output channels in the basal ganglia. Science. 1993 Feb 5;259(5096):819-21. doi: 10.1126/science.7679223.
PubMed 7679223
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
- The Study of Surround Inhibition in Patients With Dystonia
- ClinicalTrials.gov ID
- NCT00029601
- Acronym / sponsor ID
- 020088
- Conditions
- Dystonic Disorders, Healthy
- Keywords
- Magnetic Stimulation, Intracortical Inhibition, Intracortical Facilitation, Motor Evoked Potential, Reaction Time, Transcranial Magnetic Stimulation, Dystonia, Focal Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2002
- Study completion
- Jul 2002
- First posted
- 16 Jan 2002 (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 (TMS) to examine how the brain controls muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting and repetitive movement 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 [between 21 and 65 years of age] may be eligible for this study.
Participants will have transcranial magnetic stimulation. For this test, subjects are seated in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or transient tingling in the forearm, head or face muscles.) During the stimulation, subjects will be asked to either keep their hand relaxed or move a certain part of the hand in response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation.
There are three parts to the study, each lasting 2-3 hours and each performed on a separate day.
Detailed description
The purpose of this study is to evaluate modulation of inhibition within the motor cortex before and during movement in patients with focal dystonia. For a selective movement or task, certain muscles are normally recruited and others are inhibited at the cortical level. We hypothesize that a disturbance in this cortical inhibitory control could result in a failure to focus the desired motor action within the motor cortex (disturbed center surround inhibition) and may account for co-contraction of antagonist muscles and overflow into extraneous muscles in dystonic patients. Intracortical inhibition (ICI) and silent period (SP) are two major cortical inhibitory mechanisms demonstrated by transcranial magnetic stimulation (TMS). Alteration in these inhibitory mechanisms have been studied in dystonia at rest, however, as dystonic symptoms mainly occur with selective tasks or movements we plan to study intracortical inhibitory mechanisms before and during movement using different TMS paradigms.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 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 1695401Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
- Background: PubMed 7679223Hoover JE, Strick PL. Multiple output channels in the basal ganglia. Science. 1993 Feb 5;259(5096):819-21. doi: 10.1126/science.7679223.
Related trials for Dystonic Disorders
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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 Disorders 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.
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 NCT00029601, 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.