Clinical Trial: Functional Connectivity in Primary Focal Dystonia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Functional Connectivity of the Basal Ganglia in Primary Focal Dystonia

Brief Summary:

In this study we are looking at primary focal dystonias, including dystonias of the limbs, eyes, jaw or face, neck, and vocal chords. This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task.

The investigators will test the hypothesis that disturbances in functional connectivity within the motor, affective and cognitive basal ganglia networks in primary focal dystonia (PFD) underlie the motor and non-motor symptoms in this disorder.


Detailed Summary:

After written consent is obtained, all subjects undergo a neurological examination by a board certified neurologist and complete a Montreal Cognitive Assessment and Edinburgh Handedness Inventory. Primary focal dystonia (PFD) patients will have their dystonia assessed with commonly used clinical rating scales for dystonia using Unified Dystonia Rating Scale,Fahn-Marsden Scale, Global Dystonia Rating Scale, Toronto Western Spasmodic Torticollis Rating Scale—TWSTRS,and the Jankovic Rating Scale for blepharospasm. Patients and controls will have affective symptoms assessed using the Liebowitz Social Anxiety Scale, Hospital Anxiety and Depression Scale,Yale-Brown Obsessive Compulsive Scale,and Beck Depression Inventory. Clinical evaluations will be performed at the University of Colorado Denver and Denver Veterans Affairs (VA) Hospital Brain Imaging Center on the Anschutz Medical Campus, prior to Magnetic Resonance Imaging (MRI) scanning. Consenting, exam, and clinical scale assessments are estimated to take 30-40 minutes to complete.

MRI scanning protocol

MRI scanning will be performed using an 8-channel head coil and a 3 Tesla General Electric (GE) Signa MR scanner system that is FDA-approved for clinical MR scanning. The principal investigator and/or a co-investigator will be present for every scanning session. Head motion will be minimized using cushions and passive restraints. The total MRI scanning session will take approximately 50-60 minutes, including set-up time and scan time, and includes the following MRI runs:

  1. Anatomic scans: A high-resolution 3D spoiled gradient echo T1-weighted image (~8 minutes) will be collected for image registration and normalization. The subject simply rests while the sequence is run. A diffusion tensor
    Sponsor: University of Colorado, Denver

    Current Primary Outcome:

    • Contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) [ Time Frame: Day 1 ]
      Primary outcome measures for the first aim is a second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients (measures of functional connectivity associated with predefined basal ganglia regions of interest) at rest and during a tapping motor task.
    • Correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores [ Time Frame: Day 1 ]
      The primary outcome measure for the second aim is the strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores.


    Original Primary Outcome:

    • A second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients at rest and during a tapping motor task [ Time Frame: Day 1 ]
      Primary outcome measures for the first aim is a second level contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC) of the statistical parametric maps of correlation coefficients (measures of functional connectivity associated with predefined basal ganglia regions of interest) at rest and during a tapping motor task.
    • Strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores [ Time Frame: Day 1 ]
      The primary outcome measure for the second aim is the strength of correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores.


    Current Secondary Outcome:

    • Evaluation of Lateralization [ Time Frame: Day 1 ]
      Secondary outcome measures will include within group comparisons of statistical parametric maps of correlation coefficients to investigate lateralization (left versus right side of onset; left versus right tapping hand).
    • Statistical dependence between symptoms and measures of basal ganglia functional connectivity [ Time Frame: Day 1 ]
      Secondary outcome measures will include measuring statistical dependence between symptoms (assessment by clinical scale scores) and measures of basal ganglia functional connectivity.


    Original Secondary Outcome:

    • Lateralization [ Time Frame: Day 1 ]
      Secondary outcome measures will include within group comparisons of statistical parametric maps of correlation coefficients to investigate lateralization (left versus right side of onset; left versus right tapping hand).
    • Statistical dependence between symptoms and measures of basal ganglia functional connectivity [ Time Frame: Day 1 ]
      Secondary outcome measures will include measuring statistical dependence between symptoms (assessment by clinical scale scores) and measures of basal ganglia functional connectivity.


    Information By: University of Colorado, Denver

    Dates:
    Date Received: December 6, 2012
    Date Started: May 2012
    Date Completion: September 2018
    Last Updated: December 5, 2016
    Last Verified: December 2016