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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01547481
First received: February 28, 2012
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition
Movement Disorders (Incl Parkinsonism)
Tremor Familial Essential, 1
REM Sleep Behavior Disorder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • fMRI compared between cohorts [ Time Frame: one time at initial visit ] [ Designated as safety issue: No ]
    Studying resting brain activity between healthy adults, participants with Parkinson's and participants with REM Behavior Disorder.


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547481

Contacts
Contact: Frank M Skidmore, MD 205-975-3395 fskidmor@uab.edu
Contact: Paula J Spath 205-975-3395 pspath@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Frank Skidmore, MD    205-975-3395    fskidmor@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Frank Skidmore, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01547481     History of Changes
Other Study ID Numbers: fMRI - Skidmore
Study First Received: February 28, 2012
Last Updated: July 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Parkinsonian Disorders
Disease
Essential Tremor
Mental Disorders
Movement Disorders
REM Sleep Behavior Disorder
Supranuclear Palsy, Progressive
Tremor
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cranial Nerve Diseases
Dyskinesias
Eye Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Ocular Motility Disorders
Ophthalmoplegia
Paralysis
Parasomnias
Pathologic Processes
REM Sleep Parasomnias
Signs and Symptoms
Sleep Disorders
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014