Movement DisorderNCT00137384
Movement-Related Brain Networks Involved in Hand Dystonia
An observational study of Movement Disorder and Focal Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use various methods to measure the activity of the motor cortex (the part of the brain that controls movements) in order to learn more about focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement Disorder, Focal Dystonia
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2005to 27 Apr 2018
- 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
- Normal subjects: Healthy volunteers ages 18 and older who consent to participate in the study
- Patients ages 18 and older diagnosed with focal hand dystonia unilateral focal hand dystonia who consent to participate in the study
Who cannot join
- Normal subjects: abnormal neurologic exam or history of previous neurological disease that might affect the functioning of the hands
- Dystonia patients: presence of a second neurologic disease or condition that might affect the functioning of the hands; abnormal neurologic findings on exam not related to the focal hand dystonia that might affect the functioning of the hands; the use of Botulinum toxin within 3 months prior to study participation
- For MRI studies, patients with metallic implants will be excluded to avoid potential risks from this procedure
- For MRI studies, women who are pregnant are excluded from this part of the protocol. All women of childbearing potential will have a pregnancy test performed prior to MRI studies, which must be negative, before proceeding.
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: The Role of Cortical Coherence in Focal Hand Dystonia
This study will use various methods to measure the activity of the motor cortex (the part of the brain that controls movements) in order to learn more about focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved.
Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Each candidate is screened with a medical history, physical examination and questionnaire. Participants undergo the following procedures:
Read more
Finger Movement Tasks
Subjects perform two finger movement tasks. In the first part of the study, they move their index finger repetitively from side to side at 10-second intervals for a total of 200 movements in four blocks of 50 at a time. In the second part of the study, subjects touch their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats 2 times per second to help time the movements. This sequence is repeated for a total of 200 movements in four blocks of 50 at a time.
Electroencephalography
This test records brain waves. Electrodes (metal discs) are placed on the scalp with an electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while the subject performs a finger movement task, as described above.
Magnetoencephalography
MEG records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. The recording may be made while the subject performs a finger task.
Electromyography
Electromyography (EMG) measures the electrical activity of muscles. This study uses surface EMG, in which small metal disks filled with a conductive gel are taped to the skin on the finger.
Magnetic resonance imaging
MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning. Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time, and can communicate with the MRI staff at all times during the procedure.
Questionnaire
This questionnaire is designed to detect any sources of discomfort the subject may have experienced during the study.
Read the detailed description
Objective
Dystonia is a disabling movement disorder that manifests with sustained co-contraction of agonist and antagonist muscles, giving rise to abnormal twisted postures and overflow of muscle activity. Abnormal neurophysiologic parameters of the somatosensory and motor cortex have been demonstrated, although it is unclear how these changes lead to the predominant motor manifestations. In normal voluntary movement, communication between sensory and motor cortices is important and these interactions may be dysfunctional in dystonia. Coherence is a powerful method used to assess brain communication and has been instrumental in demonstrating the interregional interactions involved in normal movement. Inappropriate connectivity in terms of the duration of communication or the extent of spread over sensorimotor areas may give rise to the involuntary overflow of movements that characterize dystonia. We propose to examine changes in coherence associated with disorganized movements to yield insight as to the brain networks involved in the development and expression of the disease.
Study population
Patients with focal hand dystonia and normal volunteers will take part in the study.
Design
In this study, EEG/MEG coherence analysis will be used to investigate corticocortical and corticomuscular interactions during voluntary hand movements in focal hand dystonia patients and normal subjects. Power spectral changes in the beta and alpha frequency range over the hand sensorimotor cortex will be studied using a 28-channel EEG montage while subjects perform various tasks involving the hand. The interregional coherence between sensory and motor, premotor and motor, and interhemispheric cortices will be assessed for changes between study populations.
Outcome Measures
Comparison of interregional coherence changes will be performed between dystonia patients and normal volunteers as well as between affected and unaffected sides. Furthermore, coherence changes will be compared between rest and during task performance.
- Conditions
- Movement Disorder, Focal Dystonia
- Keywords
- Magnetoencephalogram, Functional Connectivity, Electroencephalogram (EEG), Focal Hand Dystonia, Spectral Analysis, Healthy Volunteer, HV
- Medical subject headings
- Movement Disorders, Dystonic Disorders, Dystonia, Focal, Task-Specific
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study start25 Aug 2005
- Study completion27 Apr 2018
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 Movement 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
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137384
- Sponsor's protocol ID
- 050228
- Other IDs
- 05-N-0228
- Status last verified
- 27 Apr 2018
- First submitted
- 26 Aug 2005
- Last updated
- 1 May 2018
- Results posted
- No
Publications
Abbruzzese G, Berardelli A. Sensorimotor integration in movement disorders. Mov Disord. 2003 Mar;18(3):231-240. doi: 10.1002/mds.10327.
PubMed 12621626Abbruzzese 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 11222454Andres FG, Gerloff C. Coherence of sequential movements and motor learning. J Clin Neurophysiol. 1999 Nov;16(6):520-7. doi: 10.1097/00004691-199911000-00004.
PubMed 10600020
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cortical Coherence in Focal Hand Dystonia
- ClinicalTrials.gov ID
- NCT00137384
- Acronym / sponsor ID
- 050228
- Conditions
- Movement Disorder, Focal Dystonia
- Keywords
- Magnetoencephalogram, Functional Connectivity, Electroencephalogram (EEG), Focal Hand Dystonia, Spectral Analysis, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 25 Aug 2005
- Study completion
- 27 Apr 2018
- First posted
- 29 Aug 2005 (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 various methods to measure the activity of the motor cortex (the part of the brain that controls movements) in order to learn more about focal hand dystonia. Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures. In focal dystonia, just one part of the body, such as the hand, neck or face, is involved.
Patients with focal hand dystonia and healthy normal volunteers between 18 and 65 years of age may be eligible for this study. Each candidate is screened with a medical history, physical examination and questionnaire. Participants undergo the following procedures:
Finger Movement Tasks
Subjects perform two finger movement tasks. In the first part of the study, they move their index finger repetitively from side to side at 10-second intervals for a total of 200 movements in four blocks of 50 at a time. In the second part of the study, subjects touch their thumb to the other four fingers in sequence from 1, 2, 3 and 4, while a metronome beats 2 times per second to help time the movements. This sequence is repeated for a total of 200 movements in four blocks of 50 at a time.
Electroencephalography
This test records brain waves. Electrodes (metal discs) are placed on the scalp with an electrode cap, a paste or a glue-like substance. The spaces between the electrodes and the scalp are filled with a gel that conducts electrical activity. Brain waves are recorded while the subject performs a finger movement task, as described above.
Magnetoencephalography
MEG records magnetic field changes produced by brain activity. During the test, the subjects are seated in the MEG recording room and a cone containing magnetic field detectors is lowered onto their head. The recording may be made while the subject performs a finger task.
Electromyography
Electromyography (EMG) measures the electrical activity of muscles. This study uses surface EMG, in which small metal disks filled with a conductive gel are taped to the skin on the finger.
Magnetic resonance imaging
MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The patient lies on a table that can slide in and out of the scanner (a narrow metal cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning. Most scans last between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time, and can communicate with the MRI staff at all times during the procedure.
Questionnaire
This questionnaire is designed to detect any sources of discomfort the subject may have experienced during the study.
Detailed description
Objective
Dystonia is a disabling movement disorder that manifests with sustained co-contraction of agonist and antagonist muscles, giving rise to abnormal twisted postures and overflow of muscle activity. Abnormal neurophysiologic parameters of the somatosensory and motor cortex have been demonstrated, although it is unclear how these changes lead to the predominant motor manifestations. In normal voluntary movement, communication between sensory and motor cortices is important and these interactions may be dysfunctional in dystonia. Coherence is a powerful method used to assess brain communication and has been instrumental in demonstrating the interregional interactions involved in normal movement. Inappropriate connectivity in terms of the duration of communication or the extent of spread over sensorimotor areas may give rise to the involuntary overflow of movements that characterize dystonia. We propose to examine changes in coherence associated with disorganized movements to yield insight as to the brain networks involved in the development and expression of the disease.
Study population
Patients with focal hand dystonia and normal volunteers will take part in the study.
Design
In this study, EEG/MEG coherence analysis will be used to investigate corticocortical and corticomuscular interactions during voluntary hand movements in focal hand dystonia patients and normal subjects. Power spectral changes in the beta and alpha frequency range over the hand sensorimotor cortex will be studied using a 28-channel EEG montage while subjects perform various tasks involving the hand. The interregional coherence between sensory and motor, premotor and motor, and interhemispheric cortices will be assessed for changes between study populations.
Outcome Measures
Comparison of interregional coherence changes will be performed between dystonia patients and normal volunteers as well as between affected and unaffected sides. Furthermore, coherence changes will be compared between rest and during task performance.
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)
- Normal subjects: Healthy volunteers ages 18 and older who consent to participate in the study
- Patients ages 18 and older diagnosed with focal hand dystonia unilateral focal hand dystonia who consent to participate in the study
Key exclusion criteria (4 listed)
- Normal subjects: abnormal neurologic exam or history of previous neurological disease that might affect the functioning of the hands
- Dystonia patients: presence of a second neurologic disease or condition that might affect the functioning of the hands; abnormal neurologic findings on exam not related to the focal hand dystonia that might affect the functioning of the hands; the use of Botulinum toxin within 3 months prior to study participation
- For MRI studies, patients with metallic implants will be excluded to avoid potential risks from this procedure
- For MRI studies, women who are pregnant are excluded from this part of the protocol. All women of childbearing potential will have a pregnancy test performed prior to MRI studies, which must be negative, before proceeding.
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 1 May 2018.
- Background: PubMed 12621626Abbruzzese G, Berardelli A. Sensorimotor integration in movement disorders. Mov Disord. 2003 Mar;18(3):231-240. doi: 10.1002/mds.10327.
- 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.
- Background: PubMed 10600020Andres FG, Gerloff C. Coherence of sequential movements and motor learning. J Clin Neurophysiol. 1999 Nov;16(6):520-7. doi: 10.1097/00004691-199911000-00004.
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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 Movement Disorder 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 2 inclusion and 4 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 1 May 2018. 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 NCT00137384, 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 1 May 2018.