Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
Completed
Conditions studied: Primary Lateral Sclerosis
In brief
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....
Key facts
- Study ID
- NCT00015444
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 189
- Starts
- 2001-05-01
- Expected to finish
- 2019-04-24
- Last updated by the study team
- 2019-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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