MRI Study of Brain Activity in Healthy Adults and Individuals With Parkinsonism and Rapid Eye Movement Disorder.
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ClinicalTrials.gov Identifier: NCT01547481 |
Recruitment Status
:
Completed
First Posted
: March 7, 2012
Last Update Posted
: April 12, 2017
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Condition or disease |
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Movement Disorders (Incl Parkinsonism) Tremor Familial Essential, 1 REM Sleep Behavior Disorder |
Study Type : | Observational |
Actual Enrollment : | 50 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | December 31, 2015 |
Actual Study Completion Date : | December 31, 2015 |

Group/Cohort |
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Parkinson's Disease Cohort
Individuals Diagnosed with Parkinson's Disease
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Essential Tremor cohort
Individuals Diagnosed with Essential Tremor
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Rapid Eye Movement Disorder Cohort
Individuals Diagnosed with Rapid-Eye Movement Behavior Disorder (RBD). Eligible individuals will have been diagnosed with RBD based on a sleep study prior to entering the study. This study does not pay for or support a sleep study.
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Healthy Control group
Individuals are healthy, without a known neurologic disease.
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Progressive Supranuclear Palsy Cohort
Individuals diagnosed with Progressive Supranuclear Palsy (PSP).
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Parkinsonism - Undifferentiated
Individuals with any form of Parkinsonism, not meeting any of the above cohorts.
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- fMRI compared between cohorts [ Time Frame: one time at initial visit ]Studying resting brain activity between healthy adults, participants with Parkinson's and participants with REM Behavior Disorder.

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Ages Eligible for Study: | 19 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Healthy Control • Age 35-85
Parkinson Disease (PD) Age 35-85
Diagnosis of clinically definite PD made by a movement disorders specialist, with evidence of the following features:
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Presence of bradykinesia and 1 or both of the following:
- Rest tremor
- Rigidity
- Asymmetric Onset
- Progressive motor symptoms
- Levodopa responsive
- Duration at least 1 but not more than 10 years
- Hoehn and Yahr Stage 1-2
Progressive Supranuclear Palsy (PSP) Age 40-85
Diagnosis of clinically definite PSP, with the following features:
- Gradually progressive disorder.
- Onset after age 39
- Supranuclear palsy* and postural instability with falls in the first year of disease onset*.
- No evidence of other disease.
Parkinsonism of Other or Undetermined Cause (POC) Age 35-85
Diagnosis of parkinsonism of undetermined other other cause by a movement disorders specialist, with the following features:
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Signs and symptoms of Parkinsonism including
- Bradykinesia
- Mixed or resting tremor
- Rigidity
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Characteristic deficits of gait and balance associated with Parkinsonism
Essential Tremor (ET) Age 35-85
Diagnosis of essential tremor, with the following features:
- A 2+ postural tremor of at least 1 arm (a head tremor may also be present, but is not sufficient for diagnosis)
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On examination, there must be
- a 2+ kinetic tremor during at least 4 tasks, or;
- a 2+ kinetic tremor on 1 task and a 3+ kinetic tremor on a second task; tasks include pouring water, using a spoon to drink water, drinking water, finger-to-nose, and drawing a spiral
- If on examination, the tremor is present in the dominant hand, then by report, it must interfere with at least 1 activity of daily living.
REM Behavior Disorder (RBD) Age 25 - 85
Documented diagnosis of REM sleep behavior disorder (RBD) by a sleep medicine specialist, with the following clinical features:
- Presence of REM sleep without atonia on polysomnography
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At least one of the following conditions:
- Sleep-related, behaviors by history (eg, dream enactment behavior)
- Abnormal REM sleep behavior documented during PSG monitoring
Exclusion Criteria:
Healthy Control
- Pregnancy
- First-degree blood relative affected by PD
- Neurodegenerative disease
- History of repeated head injury, encephalitis, brain surgery, stroke, dementia, neuroleptic exposure, or serious medical illness that may interfere with participation.
Parkinson Disease (PD)
- Any exclusion criteria that would exclude a healthy control patient
- Atypical features indicative of a Parkinson-Plus disorder
Progressive Supranuclear Palsy (PSP)
- Any exclusion criteria that would exclude a healthy control patient
- Any finding atypical for PSP
- Neuroradiologic evidence of relevant structural abnormality unrelated to appropriate changes known to be associated with PSP
Parkinsonism of Other or Undetermined Cause (POC)
- Any exclusion criteria that would exclude a healthy control patient
- Signs and symptoms suggestive of clear diagnosis of idiopathic Parkinson disease, Progressive Supranuclear Palsy, or Essential Tremor
Essential Tremor (ET)
- Any exclusion criteria that would exclude a healthy control patient
- No other potential etiologic factors for the tremor
- Any first-degree blood relative affected by PD
- History of neurodegenerative disease
REM Behavior Disorder (RBD)
- Any exclusion criteria that would exclude a healthy control patient
- Sleep disorder not better explained by another sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547481
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Frank Skidmore, MD | University of Alabama at Birmingham |
Responsible Party: | Dr. Frank Michael Skidmore, Assistant Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT01547481 History of Changes |
Other Study ID Numbers: |
fMRI - Skidmore |
First Posted: | March 7, 2012 Key Record Dates |
Last Update Posted: | April 12, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient data has now been collated as a de-identified dataset, that can be shared if requested. |
Additional relevant MeSH terms:
Disease Tremor Movement Disorders Mental Disorders Parkinsonian Disorders REM Sleep Behavior Disorder Essential Tremor Pathologic Processes Dyskinesias |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms Central Nervous System Diseases Basal Ganglia Diseases Brain Diseases REM Sleep Parasomnias Parasomnias Sleep Wake Disorders |