MRI Study of Brain Activity in Healthy Adults and Individuals With Parkinsonism and Rapid Eye Movement Disorder.

May 14, 2018 updated by: Dr. Frank Michael Skidmore, University of Alabama at Birmingham

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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:

  • Presence of bradykinesia and 1 or both of the following:

    1. Rest tremor
    2. 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:

  • Signs and symptoms of Parkinsonism including

    1. Bradykinesia
    2. Mixed or resting tremor
    3. Rigidity

    4. 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

    1. a 2+ kinetic tremor during at least 4 tasks, or;
    2. 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:

    1. Sleep-related, behaviors by history (eg, dream enactment behavior)
    2. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one time at initial visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Skidmore, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • fMRI - Skidmore

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient data has now been collated as a de-identified dataset, that can be shared if requested.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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