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

REM Sleep Behavior Disorder Clinical Trial

Official title:

Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547481
• Other study ID #: fMRI - Skidmore
• Status: Completed
• Start date: December 2011
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Essential Tremor
• Mental Disorders
• Movement Disorders
• Movement Disorders (Incl Parkinsonism)
• Parkinsonian Disorders
• REM Sleep Behavior Disorder
• Tremor
• Tremor Familial Essential, 1

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI compared between cohorts	Studying resting brain activity between healthy adults, participants with Parkinson's and participants with REM Behavior Disorder.	one time at initial visit