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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

June 10, 2011
June 15, 2011
May 15, 2018
September 2011
April 2016   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01373840 on ClinicalTrials.gov Archive Site
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Role of Dopamine Receptors in Primary Focal Dystonias
Role of Dopamine Receptors in Primary Focal Dystonias
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.
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Observational
Observational Model: Case-Control
Time Perspective: Prospective
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Non-Probability Sample
Any healthy control or patient with primary focal dystonia or arm or face.
  • Healthy
  • Focal Dystonias
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  • healthy controls
  • patients with focal dystonias
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Same as current
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01373840
201102481
No
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Washington University School of Medicine
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Perlmutter Joel, MD Washington University School of Medicine
Washington University School of Medicine
May 2018