Primary Lateral Sclerosis Clinical Trial
Official title:
Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
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....
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. Blood samples may be collected for measurement of potential
etiologies of PLS, including risk factor genes. 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.
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