Movement Disorders (Incl Parkinsonism)NCT01547481
MRI Study of Brain Activity in Healthy Adults and Individuals With Parkinsonism and Rapid Eye Movement Disorder.
An observational study of Movement Disorders (Incl Parkinsonism) and Tremor Familial Essential, 1, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders (Incl Parkinsonism), Tremor Familial Essential, 1, REM Sleep Behavior Disorder
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to 31 Dec 2015
- 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with PD, MSA-P, ET, or PSP will be recruited based on clinical criteria from the UAB Comprehensive Parkinson Disease and Movement Disorder Clinic located at The Kirklin Clinic at UAB. This center sees over 3,500 patients annually. Individuals with RBD will be recruited from the UAB University Hospital and UAB Highlands Sleep Disorders Center and will be identified through patient contact with a UAB Department of Neurology physician.
Who may be able to join
- 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:
- Presence of bradykinesia and 1 or both of the following:
- Rest tremor
- Rigidity
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- 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:
- Signs and symptoms of Parkinsonism including
- Bradykinesia
- Mixed or resting tremor
- Rigidity
- 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)
- 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
- At least one of the following conditions:
- Sleep-related, behaviors by history (eg, dream enactment behavior)
- Abnormal REM sleep behavior documented during PSG monitoring
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism.
Read the detailed description
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism. We focus on early diagnosis of Parkinsonism, other tremor disorders, and determine how imaging might be used to improve diagnosis. The purpose of this protocol is to gather a multi-modal dataset to explore and validate the investigator's previous research findings in prior studies.
- Conditions
- Movement Disorders (Incl Parkinsonism), Tremor Familial Essential, 1, REM Sleep Behavior Disorder
- Medical subject headings
- Movement Disorders, Tremor hereditary essential, 1, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Cohort | Individuals Diagnosed with Parkinson's Disease | |
| Essential Tremor cohort | Individuals Diagnosed with Essential Tremor | |
| 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. | |
| Healthy Control group | Individuals are healthy, without a known neurologic disease. | |
| Progressive Supranuclear Palsy Cohort | Individuals diagnosed with Progressive Supranuclear Palsy (PSP). | |
| Parkinsonism - Undifferentiated | Individuals with any form of Parkinsonism, not meeting any of the above cohorts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI compared between cohorts
Studying resting brain activity between healthy adults, participants with Parkinson's and participants with REM Behavior Disorder.
Measured: one time at initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startDec 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Disorders (Incl Parkinsonism)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frank Michael Skidmore, University of Alabama at Birmingham
- Investigators
- Frank Skidmore, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547481
- Sponsor's protocol ID
- fMRI - Skidmore
- Status last verified
- May 2018
- First submitted
- 28 Feb 2012
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient data has now been collated as a de-identified dataset, that can be shared if requested.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder
- ClinicalTrials.gov ID
- NCT01547481
- Acronym / sponsor ID
- fMRI - Skidmore
- Conditions
- Movement Disorders (Incl Parkinsonism), Tremor Familial Essential, 1, REM Sleep Behavior Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 7 Mar 2012 (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 proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism.
Detailed description
This proposal is focused on developing a reliable, valid, and reproducible imaging techniques and statistical methodology for segregation of various forms of Parkinsonism from healthy adults without Parkinsonism. We focus on early diagnosis of Parkinsonism, other tremor disorders, and determine how imaging might be used to improve diagnosis. The purpose of this protocol is to gather a multi-modal dataset to explore and validate the investigator's previous research findings in prior studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Cohort | – | –Individuals Diagnosed with Parkinson's Disease |
| Essential Tremor cohort | – | –Individuals Diagnosed with Essential Tremor |
| 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. |
| Healthy Control group | – | –Individuals are healthy, without a known neurologic disease. |
| Progressive Supranuclear Palsy Cohort | – | –Individuals diagnosed with Progressive Supranuclear Palsy (PSP). |
| Parkinsonism - Undifferentiated | – | –Individuals with any form of Parkinsonism, not meeting any of the above cohorts. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with PD, MSA-P, ET, or PSP will be recruited based on clinical criteria from the UAB Comprehensive Parkinson Disease and Movement Disorder Clinic located at The Kirklin Clinic at UAB. This center sees over 3,500 patients annually. Individuals with RBD will be recruited from the UAB University Hospital and UAB Highlands Sleep Disorders Center and will be identified through patient contact with a UAB Department of Neurology physician.
Key inclusion criteria (37 listed)
- 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:
- Presence of bradykinesia and 1 or both of the following:
- Asymmetric Onset
Key exclusion criteria (23 listed)
- 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.
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
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.
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 17 May 2018.
- Individual participant dataSharing planned: Yes. Patient data has now been collated as a de-identified dataset, that can be shared if requested.
Related trials for Movement Disorders (Incl Parkinsonism)
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Recruiting
Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function
Traumatic Brain Injury, Stroke
Recruiting
Stimulating Specific Brain Areas (VOP/VIM) With Electricity to Improve Movement and Muscle Control
Movement Disorders (Incl Parkinsonism), Stroke
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.
Frank Skidmore, MD principal investigator
University of Alabama at Birmingham
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 (Incl Parkinsonism) and Tremor Familial Essential, 1, run by University of Alabama at Birmingham 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 37 inclusion and 23 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 17 May 2018. 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.
What does the primary outcome measure?
fMRI compared between cohorts (time frame: one time at initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2018.