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Role of Dopamine Receptors in Primary Focal Dystonias

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ClinicalTrials.gov Identifier: NCT01373840
Recruitment Status : Unknown
Verified August 2011 by Washington University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : June 15, 2011
Last Update Posted : August 4, 2011
Information provided by:

Study Description
Brief Summary:
Dystonia is a disabling movement disorder characterized by repetitive patterned or sustained muscle contractions causing twisting or abnormal postures that may afflict 250,000 people in the U.S. While the pathophysiology of dystonia remains uncertain the treatment is rather rudimentary. A better understanding of neural mechanisms of dystonias is not only an invaluable prerequisite for developing better treatment options but also a step toward better understanding of the complex network of basal ganglia. In this study I will investigate if there is any difference between the dopamine receptors and dopamine in people with dystonia and healthy subjects.

Condition or disease
Healthy Focal Dystonias

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Dopamine Receptors in Primary Focal Dystonias
Study Start Date : September 2011
Estimated Primary Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Groups and Cohorts

healthy controls
patients with focal dystonias

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any healthy control or patient with primary focal dystonia or arm or face.

Inclusion Criteria:

  • Age >20
  • Male or Female
  • Any race or ethnicity
  • Primary focal dystonia (arm or cranial)
  • Ability to give informed consent

Exclusion criteria:

  • Family history of dystonia
  • Pregnancy (confirmed with negative urine pregnancy test in women of child bearing potential), breastfeeding
  • Exposure to radiation therapy
  • Any MRI contraindications such as foreign metallic implants, pacemaker, and aneurysm clip etc.
  • History of cardiac disease, uncontrolled hypertension, abnormal EKG during screening phase
  • History of exposure to any drugs affecting dopaminergic systems within the last 6 months (e.g. dopamine receptor blocking agents, cocaine, amphetamine, tetrabenazine, reserpine, L-dopa, dopamine agonists, as they might affect the dopamine receptor binding or endogenous dopamine).
  • Active depression (Beck Depression Inventory_II >14)
  • Cognitive impairment (Mini-Mental State Score <27)
  • CNS active medications such as gabapentin or narcotics, muscle relaxants which might be given for pain in the 3 days prior to study
  • History of stroke, seizure, cerebral palsy, generalized dystonia, parkinsonism, inability to hold head still during the scanning time.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373840

Contact: Pratt Stacey 314-747-5916 pratts@npg.wustl.edu

United States, Missouri
Washington University Not yet recruiting
St. Louis, Missouri, United States, 63141
Contact: Stacey Pratt    314-747-5916    pratts@npg.wustl.edu   
Principal Investigator: Morvarid Karimi, MD         
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Morvarid Karimi, MD Washington University School of Medicine
More Information

Responsible Party: Morvarid Karimi, MD, Washington University
ClinicalTrials.gov Identifier: NCT01373840     History of Changes
Other Study ID Numbers: 201102481
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Dopamine Agents
Cardiotonic Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents