Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015444
Status:
COMPLETED
Last Update Posted:
2019-12-16
First Post:
2001-04-18
Brief Title:
Screening and Natural History Primary Lateral Sclerosis and Related Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening and Natural History Primary Lateral Sclerosis and Related Disorders
Status:
COMPLETED
Status Verified Date:
2019-04-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0145 | None | None | None |