Functional Connectivity Parkinson Disease

• ClinicalTrials.gov Identifier: NCT01798563
• Recruitment Status: Completed
• First Posted: February 26, 2013
• Last Update Posted: November 1, 2019
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

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 or disease
Parkinson Disease

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
• Study Start Date: June 2011
• Actual Primary Completion Date: October 2017
• Actual Study Completion Date: October 2017

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   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.
2. 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). ]
   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.
3. 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. ]
   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 :

1. Task-related whole-brain activations. [ Time Frame: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication. ]
   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.
2. 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). ]
   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.
3. 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. ]
   Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.
4. 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. ]
   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.
5. 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). ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Colorado

University of Colorado Denver

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
• Other Study ID Numbers: 10-1311
• First Posted: February 26, 2013
• Last Update Posted: November 1, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:

Parkinson; Parkinson Disease

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases