Dopaminergic Effects on Cortical Function in Tourette's (Levodopa Protocol)

Completed · Phase 1 · Has a placebo group

Conditions studied: Tourette Syndrome

In brief

Dr. Kevin J. Black at Washington University is conducting a study to learn whether we can use MRI scans to test dopamine function in the brain and to determine whether the brain performs memory tasks differently in Tourette Syndrome (TS). TS is a movement disorder characterized by vocal tics (sounds) and motor tics (movements). We will measure how and where brain activity changes using magnetic resonance imaging (MRI) scans during memory tasks and after taking levodopa. Levodopa is a drug commonly used for the treatment of Parkinson's disease (PD), a very different movement disorder.

Key facts

Study ID

NCT00634556

Run by

Washington University School of Medicine

People needed

49

Starts

2006-02-01

Expected to finish

2010-10-01

Last updated by the study team

2018-02-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18-55.
• Tic subjects must meet DSM-IV-TR criteria for a chronic tic disorder.
• Controls are matched for age (within 4 years), sex, handedness (right-handed, non-right-handed), and education (within 2 years), and if possible for race and ethnicity

You may not qualify if…

• Inability to give competent informed consent.
• Lactation, pregnancy or possibility of pregnancy.
• Contraindication to MRI (pacemaker; nontrivial metallic foreign bodies; significant claustrophobia).
• Contraindication to levodopa or carbidopa (known allergy).
• Significant neurological disease (not counting the tic disorder).
• Current renal, cardiac or hepatic disease that would make study participation less safe.
• Head injury with loss of consciousness for more than 5 minutes or with neurological sequelae.
• Lifetime history of serious lifetime psychopathology or substance abuse. (Specific exclusions are: lifetime diagnosis of mental retardation, autism, psychosis, mania, somatization disorder, panic disorder, social phobia [excludes symptoms present only when treated with a neuroleptic], anorexia nervosa or bulimia, drug or alcohol dependence, antisocial personality disorder, or dementia, or current major depression.)
• Depot neuroleptics in the past 6 months.
• Other antipsychotics within the past 2 weeks.
• Behavioral therapy for Tics of OCD sx in the past 2 weeks.
• For one half of the subjects in each diagnostic group: any brain-active medications within the past 2 weeks. For the remaining subjects: neuroactive medications in the past 2 weeks other than SSRIs, alpha-2 agonists, norepinephrine reuptake inhibitors, or clonazepam.
• Additional exclusions for controls: No history of tic disorder, OCD or ADHD. If under age 25, no first-degree relative with a tic disorder. No exposure to neuroleptics in the past year and none ever for a period exceeding a week.

Where it is running

• Washington Universisty School of Medicine, — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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