Role of Dopamine Receptors in Primary Focal Dystonias

NCT ID: NCT01373840

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-04-30

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.

Conditions

Healthy; Focal Dystonias

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy controls

No interventions assigned to this group

patients with focal dystonias

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perlmutter Joel, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

201102481

Identifier Type: -

Identifier Source: org_study_id