Viewing Study NCT00310414



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00310414
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2006-03-31

Brief Title: fMRI Studies of Task Specificity in Focal Hand Dystonia
Sponsor: National Institute of Neurological Disorders and Stroke NINDS
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: fMRI Studies of Task Specificity in Focal Hand Dystonia
Status: COMPLETED
Status Verified Date: 2012-03-13
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will examine how the brain makes involuntary spasms and contractions in patients with focal hand dystonia FHD Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures In FHD only the hand is involved The study will use functional magnetic resonance imaging fMRI see below to study which areas of the brain are primarily affected in FHD and better understand how brain changes produce dystonia symptoms

Normal right-handed volunteers and patients with FHD who are 18-65 years of age may be eligible for this study Candidates are screened with a medical history and physical and neurological examinations Women who can become pregnant have a urine pregnancy test

All participants undergo fMRI This test uses a strong magnetic field and radio waves to obtain images of body organs and tissues The subject lies on a table that is moved into the scanner a metal cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure lasts about 90 minutes during which time the patient is asked to lie still for 10-15 minutes at a time During the procedure subjects are asked to perform some tasks including writing tapping with their hand and drawing in a zigzag motion Each task is performed using the right hand left hand and right foot
Detailed Description: Objective

Writers cramp a form of focal hand dystonia is the most frequently observed task specific dystonia Symptoms of writers cramp often appear as soon as the pen is picked up or after a few words of writing Patients with simple writers cramp have difficulties writing but carry out other tasks with the affected hand without spasms Little is known about why the hand spasms when writing while performing other tasks normally

The purpose of this study is to identify brain areas of activation associated specifically with the task of handwriting with the dystonic hand in patients with simple writers cramp Simple writers cramp can be defined by a patient exhibiting the symptoms only when writing and symptoms are not present in any other task performance Specifically for this study patients should be able to write for 20 seconds consecutively in a run We plan to use functional magnetic resonance imaging fMRI to identify the pattern of blood oxygenation level-dependent BOLD activation in the brain when different tasks are performed by different limbs in healthy volunteers and patients with focal hand dystonia

Study Population

This research will be conducted using 22 patients diagnosed with simple writers cramp and 32 healthy volunteers matched for age and gender

Design

Using a block design in functional magnetic resonance imaging fMRI we will examine the brain activity of patients and healthy volunteers while they execute three tasks writing tapping and a zigzagging motion with three separate limbs the dystonic hand the opposite hand and the right foot

Outcome Measures

The changes in signal intensity of the brain activity correlated with the motor program task of handwriting and effector dystonic hand will be collected and analyzed

The findings we expect to obtain with this experiment may contribute to basic knowledge of the linkage between task specificity and the dystonic hand and may provide a better understanding of the pathophysiology of writers cramp

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
06-N-0128 None None None