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CompletedNCT01798563Updated Nov 1, 2019

Functional Connectivity Parkinson Disease

An observational study in Parkinson Disease, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
86
Ages
50 Years to 80 Years
Sex
All
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Study 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)

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Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson
  • Parkinson Disease
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's enrollment of 86 is below the median of 96 across 1,056 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes

  1. Task-related whole-brain activations.

    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.

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

  2. Task-related whole-brain activations.

    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.

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

  3. Connectivity between other motor and non-motor brain regions during the tasks.

    Secondary outcome measures include measuring the 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.

  4. Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments

    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.

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

  5. Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments

    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.

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

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Study locations

1 site
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01798563
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Feb 26, 2013
Start date
Jun 2011
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Nov 1, 2019

Study contacts

Brian Berman, MD, MS
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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