Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
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Purpose
Objective:
The objectives of this protocol are:
to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols,
to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration,
to investigate proposed etiologies, risk factors, and biomarkers for the development of these disorders and for disease progression
Study Population:
240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral sclerosis or related upper motor neuron disorder
Design:
Patients who have been referred by physicians for primary lateral sclerosis will undergo a screening evaluation at the first visit. The screening visit will include review of outside medical records, neurological examination, and diagnostic testing to determine possible causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis by history or examination will be followed to determine the natural history of this disorder. Measures of motor and cognitive function will be made at baseline and follow-up visits to follow clinical progression. Magnetic resonance imaging will be carried out to determine if imaging changes occur over time. Patients identified in this protocol who are eligible for other research protocols will be invited to participate in additional protocols.
Outcome Measures:
Clinical progression will be documented by measures of finger-tapping, timed gait, speech. The association between clinical progression and MRI measures will be assessed as a secondary outcome.
| Condition |
|---|
|
Motor Nueron Disease Nervous System Diseases Muscle Spasticity Diffusion Tensor Imaging Disease Progression Evoked Potentials, Motor/Physiology |
| Study Type: | Observational |
| Official Title: | Screening and Natural History: Primary Lateral Sclerosis and Related Disorders |
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2001 |
Objective:
The objectives of this protocol are:
to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols,
to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration,
to investigate proposed etiologies, risk factors, and biomarkers for the development of these disorders and for disease progression
Study Population:
240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral sclerosis or related upper motor neuron disorder
Design:
Patients who have been referred by physicians for primary lateral sclerosis will undergo a screening evaluation at the first visit. The screening visit will include review of outside medical records, neurological examination, and diagnostic testing to determine possible causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis by history or examination will be followed to determine the natural history of this disorder. Measures of motor and cognitive function will be made at baseline and follow-up visits to follow clinical progression. Magnetic resonance imaging will be carried out to determine if imaging changes occur over time. Patients identified in this protocol who are eligible for other research protocols will be invited to participate in additional protocols.
Outcome Measures:
Clinical progression will be documented by measures of finger-tapping, timed gait, speech. The association between clinical progression and MRI measures will be assessed as a secondary outcome.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Age 18 years of age or older
Adult onset of progressive spasticity
No family history of a similar disorder
EXCLUSION CRITERIA:
History of stroke, cerebral palsy, traumatic brain injury or other known etiology of spasticity
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
Inability to travel to NIH
Anticoagulation will be an exclusion for needle EMG studies
Implanted devices or metal fragments in the brain or spinal cord will be an exclusion for MRI scanning
Contacts and Locations| Contact: Carol H Hoffman | (301) 496-7428 | carol.hoffman@nih.gov |
| Contact: Mary Kay Floeter, M.D. | (301) 496-7428 | floeterm@ninds.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Mary Kay Floeter, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00015444 History of Changes |
| Other Study ID Numbers: | 010145, 01-N-0145 |
| Study First Received: | April 18, 2001 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
EMG Spasticity Motor Neuron Disease Amyotrophic Lateral Sclerosis |
Primary Lateral Sclerosis Muscle Stiffness Involuntary Muscle Contraction Isaacs Syndrome |
Additional relevant MeSH terms:
|
Muscle Spasticity Nervous System Diseases Sclerosis Motor Neuron Disease Disease Progression Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia |
Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms Pathologic Processes Neurodegenerative Diseases Neuromuscular Diseases Disease Attributes |
ClinicalTrials.gov processed this record on May 16, 2013