Focal DystoniaNCT00025701
EEG and EMG Studies of Hand Dystonia
An observational study of Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine how the brain operates during execution and control of voluntary movement and what goes wrong with these processes in disease. It will use electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal subjects and in patients with focal hand dystonia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Focal Dystonia
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2001to 4 Oct 2010
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study population will consist of (a) healthy volunteers; and (b) patients with focal hand dystonia.
- Healthy subjects: Healthy volunteers who consented to participate in the study.
- Patients diagnosed with focal hand dystonia: unilateral focal hand dystonia from our dystonia patient database who consented to participate in the study.
Who cannot join
- Healthy subjects: abnormal neurological exam or history of past neurological disease.
- Dystonia patients: the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to their focal hand dystonia.
- For MRI studies, patients with metallic implants will be excluded to remove potential risks from this procedure.
- For MRI purposes, women who are pregnant are excluded from this part of the protocol. Therefore, all women of childbearing potential will have a pregnancy test performed prior to prospective MRI studies, which must be negative, before proceeding.
- For TMS studies, healthy volunteers or focal hand dystonia patients who have a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or who have a history of seizure disorder will be excluded from the trial.
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: EEG Study of Movement-Related Center-Surround Organization in Hand Dystonia
This study will examine how the brain operates during execution and control of voluntary movement and what goes wrong with these processes in disease. It will use electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements, or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one region of the body, such as the hand, neck or face.
EEG measures the electrical activity of the brain. The activity is recorded using wire electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures electrical activity from muscles. It uses wire electrodes placed on the skin over the muscles.
Read more
Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for this study. Patients will be selected from NINDS's dystonia patient database.
Participants will sit in a semi-reclining chair in a darkened room and be asked to move either their right index finger, right foot, or the angle of their mouth on the right side at a rate of one movement every 10 seconds. Brain and muscle activity will be measured during this task with EEG and EMG recordings.
Read the detailed description
Objective
- To find and quantify EEG/MEG correlates of cortical center-surround organization and intracortical inhibition.
- To compare these between healthy volunteers and focal hand dystonia (FHD) patients.
Study Population
- Healthy volunteers and FHD patients.
Design
- The study has two separate arms aiming to examine the same question. In the first one subjects perform a 4-choice contingence negative variation (CNT) type motor task while multi-channel EEG and EMG are recorded. In the second arm somatosensory evoked potentials (SEPs) or fields (SEFs) are recorded to median nerve stimulation.
Outcome Measures
- First arm: EEG band-power difference between "center" and "surround". Second arm: number, amplitude, and power of high frequency oscillations (HFOs) component of SEPs/SEFs.
- Conditions
- Focal Dystonia
- Keywords
- Cortex, Inhibition, Motor Control, Event-Related Synchronization, Event-Related Desynchronization, Focal Hand Dystonia, Focal Dystonia, Dystonia, Hand, Healthy Volunteer, HV
- Medical subject headings
- Dystonic Disorders, Inhibition, Psychological, Dystonia, Focal, Task-Specific, Dystonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2001 (estimated)
- Study start9 Oct 2001
- Study completion4 Oct 2010
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 Focal DystoniaStudies 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
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025701
- Sponsor's protocol ID
- 020010
- Other IDs
- 02-N-0010
- Status last verified
- 4 Oct 2010
- First submitted
- 11 Oct 2001
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bara-Jimenez W, Catalan MJ, Hallett M, Gerloff C. Abnormal somatosensory homunculus in dystonia of the hand. Ann Neurol. 1998 Nov;44(5):828-31. doi: 10.1002/ana.410440520.
PubMed 9818942Allard T, Clark SA, Jenkins WM, Merzenich MM. Reorganization of somatosensory area 3b representations in adult owl monkeys after digital syndactyly. J Neurophysiol. 1991 Sep;66(3):1048-58. doi: 10.1152/jn.1991.66.3.1048.
PubMed 1753275Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
PubMed 11222454
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
- EEG Study of Movement-Related Center-Surround Organization in Hand Dystonia
- ClinicalTrials.gov ID
- NCT00025701
- Acronym / sponsor ID
- 020010
- Conditions
- Focal Dystonia
- Keywords
- Cortex, Inhibition, Motor Control, Event-Related Synchronization, Event-Related Desynchronization, Focal Hand Dystonia, Focal Dystonia, Dystonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Oct 2001
- Study completion
- 4 Oct 2010
- First posted
- 12 Oct 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 examine how the brain operates during execution and control of voluntary movement and what goes wrong with these processes in disease. It will use electroencephalography (EEG) and electromyography (EMG) to compare brain function in normal subjects and in patients with focal hand dystonia. In dystonia, involuntary muscle movements, or spasms, cause uncontrolled twisting and repetitive movement or abnormal postures. Focal dystonia involves just one region of the body, such as the hand, neck or face.
EEG measures the electrical activity of the brain. The activity is recorded using wire electrodes attached to the scalp or mounted on a Lycra cap placed on the head. EMG measures electrical activity from muscles. It uses wire electrodes placed on the skin over the muscles.
Adult healthy normal volunteers and patients with focal hand dystonia may be eligible for this study. Patients will be selected from NINDS's dystonia patient database.
Participants will sit in a semi-reclining chair in a darkened room and be asked to move either their right index finger, right foot, or the angle of their mouth on the right side at a rate of one movement every 10 seconds. Brain and muscle activity will be measured during this task with EEG and EMG recordings.
Detailed description
Objective
- To find and quantify EEG/MEG correlates of cortical center-surround organization and intracortical inhibition.
- To compare these between healthy volunteers and focal hand dystonia (FHD) patients.
Study Population
- Healthy volunteers and FHD patients.
Design
- The study has two separate arms aiming to examine the same question. In the first one subjects perform a 4-choice contingence negative variation (CNT) type motor task while multi-channel EEG and EMG are recorded. In the second arm somatosensory evoked potentials (SEPs) or fields (SEFs) are recorded to median nerve stimulation.
Outcome Measures
- First arm: EEG band-power difference between "center" and "surround". Second arm: number, amplitude, and power of high frequency oscillations (HFOs) component of SEPs/SEFs.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study population will consist of (a) healthy volunteers; and (b) patients with focal hand dystonia.
- Healthy subjects: Healthy volunteers who consented to participate in the study.
- Patients diagnosed with focal hand dystonia: unilateral focal hand dystonia from our dystonia patient database who consented to participate in the study.
Key exclusion criteria (5 listed)
- Healthy subjects: abnormal neurological exam or history of past neurological disease.
- Dystonia patients: the presence of a second neurological disease or condition; abnormal neurological findings on exam that are not related to their focal hand dystonia.
- For MRI studies, patients with metallic implants will be excluded to remove potential risks from this procedure.
- For MRI purposes, women who are pregnant are excluded from this part of the protocol. Therefore, all women of childbearing potential will have a pregnancy test performed prior to prospective MRI studies, which must be negative, before proceeding.
- For TMS studies, healthy volunteers or focal hand dystonia patients who have a pacemaker, an implanted medical pump, a metal plate or metal object in the skull or eye (for example, after brain surgery), or who have a history of seizure disorder will be excluded from the trial.
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 9818942Bara-Jimenez W, Catalan MJ, Hallett M, Gerloff C. Abnormal somatosensory homunculus in dystonia of the hand. Ann Neurol. 1998 Nov;44(5):828-31. doi: 10.1002/ana.410440520.
- Background: PubMed 1753275Allard T, Clark SA, Jenkins WM, Merzenich MM. Reorganization of somatosensory area 3b representations in adult owl monkeys after digital syndactyly. J Neurophysiol. 1991 Sep;66(3):1048-58. doi: 10.1152/jn.1991.66.3.1048.
- Background: PubMed 11222454Abbruzzese G, Marchese R, Buccolieri A, Gasparetto B, Trompetto C. Abnormalities of sensorimotor integration in focal dystonia: a transcranial magnetic stimulation study. Brain. 2001 Mar;124(Pt 3):537-45. doi: 10.1093/brain/124.3.537.
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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 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 3 inclusion and 5 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 NCT00025701, 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.