Functional Connectivity in Primary Focal Dystonia

NCT01761903 | Completed

• 1 other identifier: 12-0289
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (2)

• Contrast between Primary Focal Dystonia (PFD) and Healthy Controls (HC)

  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.

  Day 1

• Correlation between basal ganglia motor network functional connectivity measures and total PFD clinical assessment scale scores

  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.

  Day 1

Secondary Outcomes (2)

• Evaluation of Lateralization

  Day 1

• Statistical dependence between symptoms and measures of basal ganglia functional connectivity

  Day 1

Study Arms (2)

Primary Focal Dystonia

Volunteers with primary focal dystonia

Healthy Controls

'Healthy' volunteers, consisting of people of the same age as the PFD volunteers, w/o a diagnosis of PFD.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult-onset primary focal dystonia patients 18 years old and older with symptoms affecting muscles of the eye (blepharospasm), jaw or face (cranial), neck (cervical), limbs (arm/leg), or vocal chords.

You may qualify if:

• English as their primary language
• Volunteers with PFD and healthy controls
• PFD volunteers must be on a stable dose of all dystonia and neuroactive drugs (e.g. antidepressants) for one month prior to enrollment
• PFD volunteers must not have been injected with botulinum toxin within the prior 2 months

You may not qualify if:

• Any contraindication to MRI scanning
• Any untreated neurological or psychiatric condition
• Evidence on neurological exam of any potentially confounding neurological disorder (e.g., Parkinson disease, Essential Tremor, etc.)
• Evidence of significant cognitive impairment (all subjects assessed using the Montreal Cognitive Assessment

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Berman, MD, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 7, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

US (1)