Clinical trial NCT01798563: Functional Connectivity Parkinson Disease
Official title: Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson
Parkinson Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)


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

Primary outcomes:
measure: Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
timeFrame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
measure: Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
timeFrame: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
measure: Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
timeFrame: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Secondary outcomes:
measure: Task-related whole-brain activations.
timeFrame: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
measure: Task-related whole-brain activations.
timeFrame: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
measure: Connectivity between other motor and non-motor brain regions during the tasks.
timeFrame: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
measure: Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
timeFrame: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
measure: Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
timeFrame: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Brian Berman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: