Movement DisordersNCT00056888
Neurophysiological Studies in Patients With Paroxysmal Hyperkinetic Movement Disorders
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use three neurophysiological tests (see below) to determine what areas of the brain are responsible for paroxysmal hyperkinetic movement disorders. Patients with these disorders have sudden, brief attacks of movement, similar to epileptic seizures, but without loss of consciousness. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2003to 17 Feb 2009
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Psychogenic paroxysmal hyperkinetic movement patients:
- Established diagnosis of psychogenic hyperkinetic movement disorders. The diagnosis will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic, based on review of medical record, history, clinical evaluation, and videotapes of an attack.
- Patients with clear onset stereotyped and defined hyperkinetic attacks.
- Patients only with paroxysmal attacks of hyperkinetic movements.
- Age 8 or older.
- A reproducible trigger of paroxysmal hyperkinetic attacks, such as sudden movement, startle or prolonged exercise, which will produce attacks at least with 50% consistency.
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- Patients whose attacks can be precipitated easily.
- Patients with typical attack involving unilateral extremities.
- Patients taking medication that may influence the central nervous system, such as phenytoin, phenobarbital, carbamazepine, clonazepam, and antidepressants (but not limited to these) will be asked to hold the medication prior to the study. A sufficient drug washout period will be established dependant upon the individual drug. Subjects may be admitted to the NIH if necessary. They will be asked to abstain from alcohol and caffeine 24 hours prior to the study as well.
- Normal Subjects:
- Normal volunteers ranging from 8 to 65 will be included. Normal volunteers would be recruited from people who are registered as HMCS Normal Volunteers. All subjects should have a valid Clinical Center Medical Record Number.
- Alcohol abstention is required for all subjects for both fMRI and EEG for 24 hours before the study.
Who cannot join
- Psychogenic paroxysmal hyperkinetic patients:
- Age younger than 8 years old.
- Patients with attacks that involve head and neck movements, axial movements, bilateral limb involvement, or violent attacks that typically make patients fall to the ground. With respect to children, violent attacks are defined as any attack that can potentially result in injury (hitting the head, falls, violent flailing, hitting furniture or walls)
- Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations.
- Contraindication to MRI such as having devices not compatible with MRI (pacemaker, an implanted medical pump, brain stimulators, etc.), metallic prostheses in their body (metal pins and rods, heart valves, cochlear implants, etc.), and history of working with metals in the past, since such persons may potentially have small metal fragments in the eye without being aware of it.
- Any diagnosis of progressive neurological disorders other than psychogenic paroxysmal hyperkinetic movement disorder.
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- Any history of significant medical disorders requiring chronic treatment with other drugs that affects the CNS, which cannot be stopped.
- Women who are pregnant or nursing. Female subjects of childbearing potential (including all girls after menarche) will have specific interview and a pregnancy test prior to the study (before each imaging procedure if required) to ensure that they are not pregnant or nursing.
- Any subject who is not capable of giving an informed consent. This will be determined at the initial evaluation at NINDS clinic. Patients with Mini Mental Score less than 25 or significant psychiatric history will be further evaluated by detailed neuropsychiatric testing, or consultation with a psychiatrist.
- Normal Volunteers:
- Normal subjects younger than 8 years and older than 65 will be excluded.
- Normal subjects with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVMs will be excluded.
- Normal subjects with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs will be excluded.
- Subjects with mental disorders will be excluded.
- We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential 24 hours prior to functional MRI scan.
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: Neurophysiological Studies in Patients With Psychogenic Movement Disorders
This study will use three neurophysiological tests (see below) to determine what areas of the brain are responsible for paroxysmal hyperkinetic movement disorders. Patients with these disorders have sudden, brief attacks of movement, similar to epileptic seizures, but without loss of consciousness.
Normal volunteers and patients with two subtypes of paroxysmal hyperkinetic movement disorder, paroxysmal dyskinesia and psychogenic variant, that can be induced by a specific trigger, such as a sudden movement or prolonged exercise, will be included in this study. Candidates must be 12 years of age or older. Women of childbearing potential will be screened with a pregnancy test.
Read more
Participants will undergo one or more of the procedures detailed below. Patients' test results will be compared with those of normal volunteers. Before each test, participants will provide a medical history and undergo a brief physical examination. During each procedure, the subject will have surface electromyography (EMG) to measure the electrical activity of muscles. For EMG, electrodes (metal discs) filled with a conductive gel are taped to the skin over the muscle to be evaluated.
Functional Magnetic Resonance Imaging (fMRI)
MRI uses a strong magnetic field, radio waves, and computer technology to provide detailed images of the brain. For this test, the subject lies in a narrow cylinder (the scanner), while pictures of the brain are taken. Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. For functional MRI (fMRI), the subject is asked to mimic a movement that occurs during an attack, such as stiffening the hand to make a fist or flexing and rotating the arm inward, to detect changes in the brain regions involved in the movement. During the procedure, involuntary movements and voluntary movements will be monitored by surface EMG and by video camera. The test will last about 1-1/2 hours.
Electroencephalography (EEG)
EEG measures the electrical activity of the brain (brain waves) with electrodes placed on the scalp. During the procedure, muscle activity will be recorded with EMG. The subject will first relax and then will be asked to mimic a movement attack. The test will last from 1-1/2 to 2 hours.
Startle Reflex
The subject will put on a headphone and hear loud noises in a random fashion. During the test, muscle activity will be recorded with EMG and with a video c...
Read the detailed description
Objective: The primary objective of this study is to determine the brain regions responsible during attacks for psychogenic paroxysmal hyperkinetic movement disorders using functional magnetic resonance imaging (fMRI). The secondary objective is to determine the neurophysiology during attacks for the same subjects compared to normal controls using electroencephalography (EEG) and Startle Reflex.
Study population: Psychogenic paroxysmal hyperkinetic movement disorder patients and a control group of healthy volunteers.
Design:
fMRI: Anatomical MRI and fMRI sequences are performed to obtain blood-oxygenation level-dependent (BOLD) imaging of brain activation during (1) triggered or provoked involuntary hyperkinetic movements and voluntary imitated movements in subjects with psychogenic paroxysmal hyperkinetic movement disorders and (2) voluntary imitated movements and rest states in healthy volunteers.
EEG: EEG will be recorded for jerk-locked back-averaging analysis.
Startle Reflex: Electromyography (EMG) will be recorded during exposure to auditory stimuli.
Outcome measures:
fMRI: BOLD will be obtained using baseline correction.
EEG
Startle Reflex: The latency, mean amplitude, and habituation of EMG amplitude will be measured.
- Conditions
- Movement Disorders
- Keywords
- Electroencephalogram, Functional (BOLD) MRI, Startle Reflex, Electromyogram, Psychogenic, Paroxysmal, Dyskinesia, Kinesiogenic, EEG, Movement-Related Potential, Movement Disorder, Paroxysmal Hyperkinetic Movement, Disorder, Paroxysmal Dyskinesia
- Medical subject headings
- Movement Disorders, Dyskinesias, Disease, Chorea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2003 (estimated)
- Study start21 Mar 2003
- Study completion17 Feb 2009
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 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
- 115 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056888
- Sponsor's protocol ID
- 030134
- Other IDs
- 03-N-0134
- Status last verified
- 17 Feb 2009
- First submitted
- 26 Mar 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Amjad AM, Halliday DM, Rosenberg JR, Conway BA. An extended difference of coherence test for comparing and combining several independent coherence estimates: theory and application to the study of motor units and physiological tremor. J Neurosci Methods. 1997 Apr 25;73(1):69-79. doi: 10.1016/s0165-0270(96)02214-5.
PubMed 9130680Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
PubMed 10355671Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
PubMed 9679773
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
- Neurophysiological Studies in Patients With Psychogenic Movement Disorders
- ClinicalTrials.gov ID
- NCT00056888
- Acronym / sponsor ID
- 030134
- Conditions
- Movement Disorders
- Keywords
- Electroencephalogram, Functional (BOLD) MRI, Startle Reflex, Electromyogram, Psychogenic, Paroxysmal, Dyskinesia, Kinesiogenic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Mar 2003
- Study completion
- 17 Feb 2009
- First posted
- 26 Mar 2003 (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 three neurophysiological tests (see below) to determine what areas of the brain are responsible for paroxysmal hyperkinetic movement disorders. Patients with these disorders have sudden, brief attacks of movement, similar to epileptic seizures, but without loss of consciousness.
Normal volunteers and patients with two subtypes of paroxysmal hyperkinetic movement disorder, paroxysmal dyskinesia and psychogenic variant, that can be induced by a specific trigger, such as a sudden movement or prolonged exercise, will be included in this study. Candidates must be 12 years of age or older. Women of childbearing potential will be screened with a pregnancy test.
Participants will undergo one or more of the procedures detailed below. Patients' test results will be compared with those of normal volunteers. Before each test, participants will provide a medical history and undergo a brief physical examination. During each procedure, the subject will have surface electromyography (EMG) to measure the electrical activity of muscles. For EMG, electrodes (metal discs) filled with a conductive gel are taped to the skin over the muscle to be evaluated.
Functional Magnetic Resonance Imaging (fMRI)
MRI uses a strong magnetic field, radio waves, and computer technology to provide detailed images of the brain. For this test, the subject lies in a narrow cylinder (the scanner), while pictures of the brain are taken. Earplugs are worn to muffle loud noises caused by electrical switching of radio frequency circuits used in the scanning process. For functional MRI (fMRI), the subject is asked to mimic a movement that occurs during an attack, such as stiffening the hand to make a fist or flexing and rotating the arm inward, to detect changes in the brain regions involved in the movement. During the procedure, involuntary movements and voluntary movements will be monitored by surface EMG and by video camera. The test will last about 1-1/2 hours.
Electroencephalography (EEG)
EEG measures the electrical activity of the brain (brain waves) with electrodes placed on the scalp. During the procedure, muscle activity will be recorded with EMG. The subject will first relax and then will be asked to mimic a movement attack. The test will last from 1-1/2 to 2 hours.
Startle Reflex
The subject will put on a headphone and hear loud noises in a random fashion. During the test, muscle activity will be recorded with EMG and with a video c...
Detailed description
Objective: The primary objective of this study is to determine the brain regions responsible during attacks for psychogenic paroxysmal hyperkinetic movement disorders using functional magnetic resonance imaging (fMRI). The secondary objective is to determine the neurophysiology during attacks for the same subjects compared to normal controls using electroencephalography (EEG) and Startle Reflex.
Study population: Psychogenic paroxysmal hyperkinetic movement disorder patients and a control group of healthy volunteers.
Design:
fMRI: Anatomical MRI and fMRI sequences are performed to obtain blood-oxygenation level-dependent (BOLD) imaging of brain activation during (1) triggered or provoked involuntary hyperkinetic movements and voluntary imitated movements in subjects with psychogenic paroxysmal hyperkinetic movement disorders and (2) voluntary imitated movements and rest states in healthy volunteers.
EEG: EEG will be recorded for jerk-locked back-averaging analysis.
Startle Reflex: Electromyography (EMG) will be recorded during exposure to auditory stimuli.
Outcome measures:
fMRI: BOLD will be obtained using baseline correction.
EEG
Startle Reflex: The latency, mean amplitude, and habituation of EMG amplitude will be measured.
Study design
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Established diagnosis of psychogenic hyperkinetic movement disorders. The diagnosis will be established by the preliminary screening in the NINDS Movement Disorders Outpatient Clinic, based on review of medical record, history, clinical evaluation, and videotapes of an attack.
- Patients with clear onset stereotyped and defined hyperkinetic attacks.
- Patients only with paroxysmal attacks of hyperkinetic movements.
- Age 8 or older.
- A reproducible trigger of paroxysmal hyperkinetic attacks, such as sudden movement, startle or prolonged exercise, which will produce attacks at least with 50% consistency.
Key exclusion criteria (15 listed)
- Age younger than 8 years old.
- Patients with attacks that involve head and neck movements, axial movements, bilateral limb involvement, or violent attacks that typically make patients fall to the ground. With respect to children, violent attacks are defined as any attack that can potentially result in injury (hitting the head, falls, violent flailing, hitting furniture or walls)
- Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations.
- Contraindication to MRI such as having devices not compatible with MRI (pacemaker, an implanted medical pump, brain stimulators, etc.), metallic prostheses in their body (metal pins and rods, heart valves, cochlear implants, etc.), and history of working with metals in the past, since such persons may potentially have small metal fragments in the eye without being aware of it.
- Any diagnosis of progressive neurological disorders other than psychogenic paroxysmal hyperkinetic movement disorder.
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 9130680Amjad AM, Halliday DM, Rosenberg JR, Conway BA. An extended difference of coherence test for comparing and combining several independent coherence estimates: theory and application to the study of motor units and physiological tremor. J Neurosci Methods. 1997 Apr 25;73(1):69-79. doi: 10.1016/s0165-0270(96)02214-5.
- Background: PubMed 10355671Andres FG, Mima T, Schulman AE, Dichgans J, Hallett M, Gerloff C. Functional coupling of human cortical sensorimotor areas during bimanual skill acquisition. Brain. 1999 May;122 ( Pt 5):855-70. doi: 10.1093/brain/122.5.855.
- Background: PubMed 9679773Berardelli A, Rothwell JC, Hallett M, Thompson PD, Manfredi M, Marsden CD. The pathophysiology of primary dystonia. Brain. 1998 Jul;121 ( Pt 7):1195-212. doi: 10.1093/brain/121.7.1195.
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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 Movement Disorders, 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 12 inclusion and 15 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 NCT00056888, 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.