View Clinical Trial (Medical Research Study)
Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Motor Nueron Disease - Nervous System Diseases - Muscle Spasticity - Diffusion Tensor Imaging - Disease Progression - Evoked Potentials, Motor/Physiology |
| Purpose: |
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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.
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| Study Summary: |
|
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.
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| Criteria: |
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- 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
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| NCT ID: |
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NCT00015444 |
| Primary Contact: |
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Principal Investigator
Mary Kay Floeter, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Carol H Hoffman
Phone: (301) 496-7428
Email: carol.hoffman@nih.gov
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| Backup Contact: |
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Email: floeterm@ninds.nih.gov
Mary Kay Floeter, M.D.
Phone: (301) 496-7428
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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