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Role of Dopamine Receptors in Primary Focal Dystonias

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ClinicalTrials.gov Identifier: NCT01373840
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine

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 Type : Observational
Actual 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
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Group/Cohort
healthy controls
patients with focal dystonias




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.
Criteria

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.

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


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Perlmutter Joel, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01373840     History of Changes
Other Study ID Numbers: 201102481
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Washington University School of Medicine:
focal
dystonia
dopamine
receptor

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