Overview

This trial is active, not recruiting.

Conditions movement disorders (incl parkinsonism), tremor familial essential, 1, rem sleep behavior disorder
Sponsor University of Alabama at Birmingham
Start date December 2011
End date December 2018
Trial size 50 participants
Trial identifier NCT01547481, fMRI - Skidmore

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Individuals Diagnosed with Parkinson's Disease
Individuals Diagnosed with Essential Tremor
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.
Individuals are healthy, without a known neurologic disease.
Individuals diagnosed with Progressive Supranuclear Palsy (PSP).
Individuals with any form of Parkinsonism, not meeting any of the above cohorts.

Primary Outcomes

Measure
fMRI compared between cohorts
time frame: one time at initial visit

Eligibility Criteria

Male or female participants from 19 years up to 85 years old.

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

Additional Information

Official title Statistical Mapping of the Brain in Progressive Supranuclear Palsy, Essential Tremor, Parkinson Disease, Parkinsonism, and REM Behavior Disorder
Principal investigator Frank Skidmore, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.