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

NCT ID: NCT01547481

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-12-31

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Parkinson's Disease Cohort

Individuals Diagnosed with Parkinson's Disease

No interventions assigned to this group

Essential Tremor cohort

Individuals Diagnosed with Essential Tremor

No interventions assigned to this group

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.

No interventions assigned to this group

Healthy Control group

Individuals are healthy, without a known neurologic disease.

No interventions assigned to this group

Progressive Supranuclear Palsy Cohort

Individuals diagnosed with Progressive Supranuclear Palsy (PSP).

No interventions assigned to this group

Parkinsonism - Undifferentiated

Individuals with any form of Parkinsonism, not meeting any of the above cohorts.

No interventions assigned to this group

Eligibility 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)

• Atypical features indicative of a Parkinson-Plus disorder

Progressive Supranuclear Palsy (PSP)

• 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)

• Signs and symptoms suggestive of clear diagnosis of idiopathic Parkinson disease, Progressive Supranuclear Palsy, or Essential Tremor

Essential Tremor (ET)

• No other potential etiologic factors for the tremor
• Any first-degree blood relative affected by PD
• History of neurodegenerative disease

REM Behavior Disorder (RBD)

• Sleep disorder not better explained by another sleep disorder, medical or neurological disorder, mental disorder, medication use, or substance use disorder

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dr. Frank Michael Skidmore

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Skidmore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

fMRI - Skidmore

Identifier Type: -

Identifier Source: org_study_id