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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 18, 2001 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | April 2001 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00015444 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Screening Protocol for Patients With Neurologic Disorders With Muscle Stiffness | ||||||||
| Official Title ICMJE | Screening: Neurologic Disorders With Muscle Stiffness | ||||||||
| Brief Summary | This study will evaluate patients with muscle stiffness for possible participation in current or future research studies. It will determine the cause of muscle stiffness or cramps and measure the severity of symptoms. Children and adults with muscle stiffness, cramps or spasticity may be eligible for this study. Participants will provide a medical history and have a physical examination. In addition to the standard neurological examination, patients may be tested on how long it takes to make some movements, such as walking or tapping on a keyboard. To determine the cause of the muscle problem, patients may also undergo blood tests and the following procedures: Magnetic resonance imaging (MRI) - MRI uses a strong magnetic field and radio waves to show structural and chemical changes in tissue. The patient lies on a table in a space enclosed by a metal cylinder (the scanner) for about 45 minutes, lying very still for 10 to 15 minutes at a time. The patient can communicate with the technician at all times during the procedure. Electromyography (EMG) and nerve conduction studies - EMG measures the electrical activity of the muscles. A needle is inserted into a muscle to record its electrical activity. Nerve conduction studies measure the speed with which nerves conduct electrical impulses. A wire is taped on the skin over a nerve to deliver a small electrical stimulus and another wire taped to the skin records the impulses. Patients will also be asked to fill out a health questionnaire no more than once a year. The information will be used to determine their eligibility for new studies. |
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| Detailed Description | The purpose of this protocol is to perform a screening evaluation of patients referred with muscle stiffness and to determine the cause of the abnormal muscle contraction. Muscle stiffness can be caused by abnormalities of the muscle itself, of peripheral nerves, or by disorders of the central nervous system. Diagnostic tests such as Nerve conduction studies and electromyography can help to determine the site of abnormality. This protocol is intended to identify patients for participation in future investigations of how the spinal and peripheral motor system coordinate movement. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 240 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Adult or pediatric patients with involuntary muscle contraction, muscle cramps, or spasticity. EXCLUSION CRITERIA Non-neurological disorders producing muscle stiffness, such as fasciitis or rheumatological conditions. Disorders in which pain limits the ability to move muscles, such as fibromyalgia or complex regional pain syndromes. Profound weakness of voluntary movement. Anticoagulation will be an exclusion for needle EMG. Implanted devices or metal fragments in the brain or spinal cord will be an exclusion for MRI scanning. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00015444 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 010145, 01-N-0145 | ||||||||
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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