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Completed

NCT Number: NCT01798563

Functional Connectivity Parkinson Disease

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)

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2013
Registry last updated
Nov 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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