Functional Connectivity Parkinson Disease

Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease

In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.

The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)

Study Overview

• Status: Completed
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic. Controls will be recruited from spouses and from the community

Description

Inclusion Criteria:

• English as their primary language
• Patients with Parkinson disease and healthy controls will be enrolled
• Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month

Exclusion Criteria:

• If unable to provide informed consent
• Pregnancy
• Excess of 300lbs
• Claustrophobia
• Metal in body
• Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
• Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
• Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Tremor Dominant PD; Volunteers with predominantly tremor-related motor symptoms of PD
Postural Instability & Gait Difficulty PD; Volunteers with primarily walking & balance-related motor symptoms of PD.
Healthy Controls; Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.	A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.	At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.	A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.	At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).	Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.	At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task-related whole-brain activations.	Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.	At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
Task-related whole-brain activations.	Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.	At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Connectivity between other motor and non-motor brain regions during the tasks.	Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.	At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments	Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.	At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments	Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.	At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Brian Berman, MD, MS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 26, 2013

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Parkinson; Parkinson Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 10-1311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No