Functional Connectivity Parkinson Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01798563
First received: December 11, 2012
Last updated: April 25, 2016
Last verified: April 2016
  Purpose

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)


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Correlation coefficients between nodes of the motor network at rest and during a tapping motor task. [ Time Frame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication. ] [ Designated as safety issue: No ]
    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.

  • Correlation coefficients between nodes of the motor network at rest and during a tapping motor task. [ Time Frame: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s). ] [ Designated as safety issue: No ]
    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.

  • Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC). [ Time Frame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Task-related whole-brain activations. [ Time Frame: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication. ] [ Designated as safety issue: No ]
    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.

  • Task-related whole-brain activations. [ Time Frame: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s). ] [ Designated as safety issue: No ]
    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.

  • Connectivity between other motor and non-motor brain regions during the tasks. [ Time Frame: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication. ] [ Designated as safety issue: No ]
    Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.

  • Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments [ Time Frame: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication. ] [ Designated as safety issue: No ]
    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.

  • Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments [ Time Frame: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 72
Study Start Date: June 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
Criteria

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
  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: NCT01798563

Contacts
Contact: Erika Shelton 303-724-5865 erika.shelton@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Brian Berman, MD, MS University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01798563     History of Changes
Other Study ID Numbers: 10-1311 
Study First Received: December 11, 2012
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Parkinson
Parkinson Disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on May 02, 2016