Functional Connectivity Parkinson Disease

NCT ID: NCT01798563

Last Updated: 2019-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-10-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Tremor Dominant PD

Volunteers with predominantly tremor-related motor symptoms of PD

No interventions assigned to this group

Postural Instability & Gait Difficulty PD

Volunteers with primarily walking \& balance-related motor symptoms of PD.

No interventions assigned to this group

Healthy Controls

Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Berman, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

10-1311

Identifier Type: -

Identifier Source: org_study_id