Functional Connectivity Parkinson Disease

NCT01798563 | Completed

• 1 other identifier: 10-1311
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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)

Conditions

Parkinson Disease

Keywords

Parkinson; Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Task-related whole-brain activations.

  At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.

• Task-related whole-brain activations.

  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.

  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

  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

  At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).

Study Arms (3)

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 Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Brian Berman, MD, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: February 26, 2013
• Study Start: June 1, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 1, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)