Physiological Investigations of Movement Disorders (NCT01019343) | Clinical Trial Compass
CompletedNot Applicable
Physiological Investigations of Movement Disorders
United States1,273 participantsStarted 2009-12-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
INCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS:
* Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the sub-study
* Age 18 or older
* Able to give informed consent
* Agree to not drink caffeine or alcohol for 48 hours before certain study sessions 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 certain study sessions 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study uses brain imaging and recording techniques like MRI, EEG, MEG, and TMS to investigate movement disorders — since it's completed, would my doctor be able to find any published results or findings that might be relevant to understanding my specific condition?
2Since this trial used TMS, which sends magnetic pulses to the brain, are there any safety considerations around that technique that my doctor thinks I should be aware of, especially given my particular diagnosis?
3This was a physiological investigation study rather than a treatment trial, so it was measuring how movement disorders work in the brain rather than testing a therapy — does my doctor think participating in or reviewing research like this could still inform decisions about my treatment plan?
4Given that this trial covered several different conditions including Parkinson's disease, Tourette's syndrome, dystonia, and other movement disorders, would my doctor know whether the findings from people with my specific diagnosis were separated out in a meaningful way?
5Are there any currently open studies similar to this one that combine brain imaging and behavioral measures for my condition, and would my doctor recommend exploring those as a next step?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MRI
Timeframe: throughout
2
EEG and MEG
Timeframe: throughout
3
TMS
Timeframe: throughout
4
Behavioral measures
Timeframe: throughout
Trial details
NCT IDNCT01019343
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)