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Screening Protocol for Patients With Neurologic Disorders With Muscle Stiffness
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), March 2009
First Received: April 18, 2001   Last Updated: August 24, 2009   History of Changes
Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00015444
  Purpose

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.


Condition
Neurological Disorder
Muscle Cramp

Study Type: Observational
Official Title: Screening: Neurologic Disorders With Muscle Stiffness

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 240
Study Start Date: April 2001
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015444

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 010145, 01-N-0145
Study First Received: April 18, 2001
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00015444     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Spasms
Spasticity
Cramps
Neuromyotonia
EMG
Muscle Stiffness
Involuntary Muscle Contraction
Spasticity
Isaacs Syndrome

Additional relevant MeSH terms:
Signs and Symptoms
Neuromuscular Manifestations
Muscular Diseases
Pathologic Processes
Disease
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Muscle Cramp

ClinicalTrials.gov processed this record on November 30, 2009