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Dystonia | Functional Connectivity in Primary Focal Dystonia

Dystonia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dystonia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Primary Focal DystoniaVolunteers 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.

Study Status

Active, not recruiting

Start Date: May 2012

Completed Date: September 2019

Phase:

Type: Observational

Design:

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

Secondary Outcome: Evaluation of Lateralization

Study sponsors, principal investigator, and references

Principal Investigator: Brian Berman, MD, MS

Lead Sponsor: University of Colorado, Denver

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01761903

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