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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01373840
Other study ID # 201102481
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2011
Est. completion date April 2016

Study information

Verified date May 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Washington University Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

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