Role of Dopamine Receptors in Primary Focal Dystonias

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01373840

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
Healthy Focal Dystonias

Study Design

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 :

Sep 1, 2011

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
healthy controls
patients with focal dystonias

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.