Physiological Investigations of Movement Disorders
This study is currently recruiting participants.
Verified January 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01019343
First received: November 24, 2009
Last updated: January 24, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Background:
- Previous studies have given researchers information on how the brain controls movement, how people learn to make fine, skilled movements, and why some people have movement disorders. However, further research is needed to learn more about the causes of most movement disorders, such as Parkinson's disease.
- By using small, specialized studies to evaluate people with movement disorders and compare them with healthy volunteers, researchers hope to learn more about the changes in the brain and possible causes of movement disorders.
Objectives:
- To better understand how the brain controls movement.
- To learn more about movement disorders.
- To train movement disorder specialists.
Eligibility:
- Individuals 18 years of age or older who have had a movement disorder diagnosed by a neurologist and are able to participate based on the specific requirements of the small study.
- Healthy volunteers 18 years of age or older.
Design:
- Participants will have a screening visit with medical history, physical examination, and questionnaire to determine eligibility. Eligible participants will give consent to participate in up to seven additional outpatient visits for study procedures. The number of sessions and the procedures needed for participation depend on specific symptoms.
- Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea) for at least 2 days (48 hours) before each session.
- Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI scans, electroencephalography, magnetoencephalography, transcranial magnetic stimulation, nerve and sensory stimulation, or movement and mental tasks during any of the above procedures.
- This study does not provide treatment for movement disorders. Participants will not have to stop any treatment in order to participate.
| Condition |
|---|
|
Parkinson's Disease Tourette's Syndrome Tic Disorders Dystonia Movement Disorders |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Physiological Investigations of Movement Disorders |
Resource links provided by NLM:
Genetics Home Reference related topics:
dopa-responsive dystonia
early-onset primary dystonia
Parkinson disease
Perry syndrome
sepiapterin reductase deficiency
Tourette syndrome
MedlinePlus related topics:
Dystonia
MRI Scans
Movement Disorders
Parkinson's Disease
Tourette Syndrome
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
- INCLUSION CRITERIA:
INCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:
- Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the substudy
- Age 18 or older
- Able to give informed consent
- Agree to not drink caffeine or alcohol for 48 hours before each study session because both agents can modify brain activity and may confound outcome measures.
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- Age 18 or older.
- Able to give informed consent.
- Agree to not drink caffeine or alcohol for 48 hours before each study session because both agents may modify the activity of the brain during the study.
EXCLUSION CRITERIA:
EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:
- Have used illegal drugs within the past 6 months
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man.
- Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Have a psychotic disorder, Bipolar Disorder or a current depressive episode.
- Have another neurologic disorder than a movement disorder
- Have had a head injury where there was a loss of consciousness for more than a few seconds.
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- Have abnormal findings on a neurological examination that we will perform
- Have used illegal drugs within the past 6 months
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
- Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Have major depression or any major mental disorders (axis I disorders)
- Have a neurological disorder.
- Have had a head injury where there was a loss of consciousness for more than a few seconds.
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR fMRI:
- Have metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
- Have metallic dental fillings which are likely to cause MRI artifacts
- Unable to lie flat on the back for up to 2 hours
- Have uncontrolled movements of the head
- Have an abnormality on the brain imaging or neurologic examination
- Uncomfortable being in a small space for up to 2 hours
- Pregnancy
ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR TMS:
- Have metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye, as these make TMS unsafe.
- Have hearing loss.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019343
Contacts
| Contact: Elaine P Considine, R.N. | (301) 435-8518 | considinee@ninds.nih.gov |
| Contact: Mark Hallett, M.D. | (301) 496-9526 | hallettm@ninds.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Mark Hallett, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT01019343 History of Changes |
| Other Study ID Numbers: | 100009, 10-N-0009 |
| Study First Received: | November 24, 2009 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Tourette Syndrome Magnetic Resonance Imaging (MRI) Magnetoencephalogram Electroencephalogram (EEG) Transcranial Magnetic Stimulation (TMS) Motor Deficit |
Dystonia Movement Disorder Parkinson Disease PD TS Tic Disorder |
Additional relevant MeSH terms:
|
Tourette Syndrome Dystonia Dystonic Disorders Movement Disorders Parkinson Disease Tic Disorders Tics Dyskinesias Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Central Nervous System Diseases Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Mental Disorders Diagnosed in Childhood Mental Disorders Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 19, 2013