HyperkinesisNCT00051337
Single Photon Emission Computed Tomography (SPECT) to Study Paroxysmal Hyperkinetic Movement Disorders
An observational study of Hyperkinesis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will use single photon emission computed tomography (SPECT) 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?
- Any age
- Conditions the study is for
- Hyperkinesis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jan 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Established diagnosis of paroxysmal 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 video tapes of an attack.
- Age 18 or older.
- A reproducible trigger of paroxysmal hyperkinetic attacks, such as sudden movement, or prolonged exercise, which will produce attacks at least with 50% consistency.
- Patients only with paroxysmal attacks of hyperkinetic movements.
- Patients whose attacks can be precipitated easily.
- Patients whose typical attack last at least 15 seconds.
Show all 16Show fewer
- Patients taking medication that may influence the central nervous system, such as phenytoin, phenobarbital, carbamazepine, clonazepam, and antidepressants (but not limited to these) for their paroxysmal dyskinesias (not seizures) 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.
- INCLUSION CRITERIA - Psychogenic paroxysmal hyperkenetic movement attack 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 video tapes of an attack.
- Patients with clear onset, stereotyped, defined and evaluable hyperkinetic attacks.
- Patients only with paroxysmal attacks of hyperkinetic movements.
- Age 18 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.
- Patients whose attacks can be precipitated easily.
- Patients whose typical attack last at least 15 seconds.
- 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.
Who cannot join
- Age younger than 18 years old.
- 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 paroxysmal hyperkinetic movement disorder.
- Any history of significant medical disorders requiring chronic treatment with other drugs that affect the CNS, which cannot be stopped.
- Ongoing radiation therapy for medical condition such as cancer.
- Women who are pregnant or nursing. Female subjects of child bearing potential 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.
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 Physiology of Paroxysmal Hyperkinetic Movement Disorders: A SPECT Study
This study will use single photon emission computed tomography (SPECT) 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. SPECT is a nuclear medicine test that produces three-dimensional images of the brain, showing blood flow and function in different brain regions. This test, which can detect the focus of epileptic seizures, will be used in this study to scan patients while they are experiencing a hyperkinetic movement attack, while they are not having and attack, and while they are simulating an attack.
Patients 18 years of age and older who have paroxysmal movement attacks that can be easily induced by a specific trigger, such as a sudden movement or prolonged exercise, may be eligible for this study. Candidates will be screened with a medical history and review of their medical records, physical examination, videotape of attacks, and, for women, a pregnancy test.
Read more
Participants will have three SPECT scans, separated from each other by at least 48 hours. Before each scan, the subject will perform an activity that ordinarily precipitates a movement attack, such as standing up from a chair, assuming a certain posture, or doing something strenuous. Each scan will try to record one of the following conditions:
- The subject performs the trigger activity, but does not have an attack;
- The subject performs the trigger activity and has an involuntary attack as a result;
- The subject performs the trigger activity and does not have an attack, but then mimics an attack voluntarily.
After the condition is recorded, the subject will be given an injection of a radioactive agent called 99m Technetium and will then relax quietly for 40 to 60 minutes before the SPECT scan. For the scan, the subject lies on an examination table and the SPECT camera is moved near and around the head to image the brain. The scan takes about 40 minutes.
Participants will also undergo one magnetic resonance imaging (MRI) scan. 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. The procedure takes about 30 minutes.
Read the detailed description
The purpose of this study is to determine the areas of the brain responsible for paroxysmal hyperkinetic movement disorders. Paroxysmal hyperkinetic movement disorders have been clinically recognized for a long time, although the exact neurophysiological mechanism leading to paroxysms of hyperkinetic movement attacks is not well understood. Paroxysmal hyperkinetic movement disorders are heterogenous, and the exact mechanism may differ in each subcategory. In paroxysmal dyskinesias, the idiopathic forms of paroxysmal hyperkinetic movement disorders, it is speculated that transient functional abnormality at the cellular level occurs in the basal ganglia without organic irreversible damage. Ion channel dysfunction is an attractive hypothesis to explain such transient dysfunction. Some patients with paroxysmal hyperkinetic movement disorders have a psychogenic etiology.
A promising technique to evaluate physiological changes in the brain during an attack is ictal single photon emission computed tomography (SPECT) scanning. Ictal SPECT is a reliable method to detect a seizure focus during an epileptic seizure. We will utilize ictal SPECT scanning techniques during, and between attacks, and while they are simulating such attacks. The differential activation between the attacks of hyperkinetic movements and the voluntary movements may shed light on the regions of the brain and neurophysiological mechanisms responsible for generation of paroxysmal hyperkinetic movement disorders.
- Conditions
- Hyperkinesis
- Keywords
- Kinesiogenic, Psychogenic, Channelopathy, Ictal, Paroxysmal Dyskinesia, Psychogenic Movement Disorders, Single Photon Emission, Computed Tomography (SPECT)
- Medical subject headings
- Hyperkinesis, Channelopathies, Chorea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2003 (estimated)
- Study startJan 2003
- Study completionJan 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 HyperkinesisStudies of the same condition, open and under way.
- 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
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051337
- Sponsor's protocol ID
- 030072
- Other IDs
- 03-N-0072
- Status last verified
- Jan 2005
- First submitted
- 8 Jan 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Demirkiran M, Jankovic J. Paroxysmal dyskinesias: clinical features and classification. Ann Neurol. 1995 Oct;38(4):571-9. doi: 10.1002/ana.410380405.
PubMed 7574453Kertesz A. Paroxysmal kinesigenic choreoathetosis. An entity within the paroxysmal choreoathetosis syndrome. Description of 10 cases, including 1 autopsied. Neurology. 1967 Jul;17(7):680-90. doi: 10.1212/wnl.17.7.680. No abstract available.
PubMed 6067487Stevens H. Paroxysmal choreo-athetosis. A form of reflex epilepsy. Arch Neurol. 1966 Apr;14(4):415-20. doi: 10.1001/archneur.1966.00470100071009. No abstract available.
PubMed 5906466
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 Physiology of Paroxysmal Hyperkinetic Movement Disorders: A SPECT Study
- ClinicalTrials.gov ID
- NCT00051337
- Acronym / sponsor ID
- 030072
- Conditions
- Hyperkinesis
- Keywords
- Kinesiogenic, Psychogenic, Channelopathy, Ictal, Paroxysmal Dyskinesia, Psychogenic Movement Disorders, Single Photon Emission, Computed Tomography (SPECT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jan 2003
- Study completion
- Jan 2005
- First posted
- 9 Jan 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 single photon emission computed tomography (SPECT) 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. SPECT is a nuclear medicine test that produces three-dimensional images of the brain, showing blood flow and function in different brain regions. This test, which can detect the focus of epileptic seizures, will be used in this study to scan patients while they are experiencing a hyperkinetic movement attack, while they are not having and attack, and while they are simulating an attack.
Patients 18 years of age and older who have paroxysmal movement attacks that can be easily induced by a specific trigger, such as a sudden movement or prolonged exercise, may be eligible for this study. Candidates will be screened with a medical history and review of their medical records, physical examination, videotape of attacks, and, for women, a pregnancy test.
Participants will have three SPECT scans, separated from each other by at least 48 hours. Before each scan, the subject will perform an activity that ordinarily precipitates a movement attack, such as standing up from a chair, assuming a certain posture, or doing something strenuous. Each scan will try to record one of the following conditions:
- The subject performs the trigger activity, but does not have an attack;
- The subject performs the trigger activity and has an involuntary attack as a result;
- The subject performs the trigger activity and does not have an attack, but then mimics an attack voluntarily.
After the condition is recorded, the subject will be given an injection of a radioactive agent called 99m Technetium and will then relax quietly for 40 to 60 minutes before the SPECT scan. For the scan, the subject lies on an examination table and the SPECT camera is moved near and around the head to image the brain. The scan takes about 40 minutes.
Participants will also undergo one magnetic resonance imaging (MRI) scan. 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. The procedure takes about 30 minutes.
Detailed description
The purpose of this study is to determine the areas of the brain responsible for paroxysmal hyperkinetic movement disorders. Paroxysmal hyperkinetic movement disorders have been clinically recognized for a long time, although the exact neurophysiological mechanism leading to paroxysms of hyperkinetic movement attacks is not well understood. Paroxysmal hyperkinetic movement disorders are heterogenous, and the exact mechanism may differ in each subcategory. In paroxysmal dyskinesias, the idiopathic forms of paroxysmal hyperkinetic movement disorders, it is speculated that transient functional abnormality at the cellular level occurs in the basal ganglia without organic irreversible damage. Ion channel dysfunction is an attractive hypothesis to explain such transient dysfunction. Some patients with paroxysmal hyperkinetic movement disorders have a psychogenic etiology.
A promising technique to evaluate physiological changes in the brain during an attack is ictal single photon emission computed tomography (SPECT) scanning. Ictal SPECT is a reliable method to detect a seizure focus during an epileptic seizure. We will utilize ictal SPECT scanning techniques during, and between attacks, and while they are simulating such attacks. The differential activation between the attacks of hyperkinetic movements and the voluntary movements may shed light on the regions of the brain and neurophysiological mechanisms responsible for generation of paroxysmal hyperkinetic movement disorders.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Established diagnosis of paroxysmal 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 video tapes of an attack.
- Age 18 or older.
- A reproducible trigger of paroxysmal hyperkinetic attacks, such as sudden movement, or prolonged exercise, which will produce attacks at least with 50% consistency.
- Patients only with paroxysmal attacks of hyperkinetic movements.
- Patients whose attacks can be precipitated easily.
Key exclusion criteria (8 listed)
- Age younger than 18 years old.
- 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 paroxysmal hyperkinetic movement disorder.
- Any history of significant medical disorders requiring chronic treatment with other drugs that affect the CNS, which cannot be stopped.
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 7574453Demirkiran M, Jankovic J. Paroxysmal dyskinesias: clinical features and classification. Ann Neurol. 1995 Oct;38(4):571-9. doi: 10.1002/ana.410380405.
- Background: PubMed 6067487Kertesz A. Paroxysmal kinesigenic choreoathetosis. An entity within the paroxysmal choreoathetosis syndrome. Description of 10 cases, including 1 autopsied. Neurology. 1967 Jul;17(7):680-90. doi: 10.1212/wnl.17.7.680. No abstract available.
- Background: PubMed 5906466Stevens H. Paroxysmal choreo-athetosis. A form of reflex epilepsy. Arch Neurol. 1966 Apr;14(4):415-20. doi: 10.1001/archneur.1966.00470100071009. 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 Hyperkinesis, 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 16 inclusion and 8 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 NCT00051337, 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.