Skip to main content
Clinical Trials/NCT01798563
NCT01798563
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country86 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Colorado, Denver
Enrollment
86
Locations
1
Primary Endpoint
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
Status
Completed
Last Updated
6 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
October 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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.)
  • Task-related whole-brain activations.(At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).)
  • 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 Sites (1)

Loading locations...

Similar Trials