Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334516
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2006-06-07
Brief Title:
Brain Function in Primary Lateral Sclerosis and Amyotrophic Lateral Sclerosis
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Cortical Function in Primary Lateral Sclerosis and Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2015-08-03
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:
This study will test whether primary lateral sclerosis PLS and amyotrophic lateral sclerosis ALS affect parts of the brain responsible for thinking planning memory and emotion
Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible for this study
Participants undergo the following procedures
Rating motor function Subjects are asked to contract certain muscles in the face arms and legs to tap their finger on a keyboard rapidly to walk 20 feet and to read a paragraph out loud
Electroencephalography EEG The electrical activity of the brain brain waves is recorded while subjects tap their finger very slowly For this test electrodes are placed on the scalp using a cap or an adhesive substance A conductive gel is used to fill the space between the electrodes and the scalp to ensure good contact
Surface electromyography EMG The electrical activity of the muscles is measured Electrodes filled with a conductive gel are taped to the skin over the muscle tested
Neuropsychological testing Testing may include questionnaires pen-and-paper or computerized tests and motor tasks
Magnetic resonance imaging MRI MRI uses a strong magnetic field and radio waves to produce images of the brain The subject lies on a table that slides into the scanner Scanning time varies from 20 minutes to 3 hours with most scans lasting 45-90 minutes
Healthy volunteers 18 years of age and older and patients with PLS and ALS may be eligible for this study
Participants undergo the following procedures
Rating motor function Subjects are asked to contract certain muscles in the face arms and legs to tap their finger on a keyboard rapidly to walk 20 feet and to read a paragraph out loud
Electroencephalography EEG The electrical activity of the brain brain waves is recorded while subjects tap their finger very slowly For this test electrodes are placed on the scalp using a cap or an adhesive substance A conductive gel is used to fill the space between the electrodes and the scalp to ensure good contact
Surface electromyography EMG The electrical activity of the muscles is measured Electrodes filled with a conductive gel are taped to the skin over the muscle tested
Neuropsychological testing Testing may include questionnaires pen-and-paper or computerized tests and motor tasks
Magnetic resonance imaging MRI MRI uses a strong magnetic field and radio waves to produce images of the brain The subject lies on a table that slides into the scanner Scanning time varies from 20 minutes to 3 hours with most scans lasting 45-90 minutes
Detailed Description:
Objective
The goal of this study is to see whether patterns of cerebral cortex dysfunction differ in Primary lateral sclerosis PLS and amyotrophic lateral sclerosis ALS The function of several regions of the cerebral cortex will be assessed by clinical physiological and neuropsychological tests Magnetic resonance imaging will be carried out in a subset of patients to explore the correlation between functional and anatomical measures of these cortical areas
Study Population
30 patients with Primary lateral sclerosis who meet the diagnostic criteria for PLS proposed by Pringle and 30 patients with ALS who fulfill the revised El Escorial criteria for probable or definite ALS
30 healthy volunteers will be studied to provide training and practice in using the rating scales and to provide age-matched controls for EEG and imaging studies
Design
A screening examination will be carried out under protocol 01-N-0145 to determine eligibility Patients and caregivers will return for two or three visits for sessions of neuropsychological testing a structured clinical neuropsychiatric evaluation ratings of motor and clinical function and measurement of movement-related cortical potentials with EEG A subset of patients will undergo MRI scans for quantitative anatomical measures of cortical regions
Outcome Measures
The primary outcome will be the classification of patients as normal or abnormal on neuropsychological testing of frontal cortex function Correlations of the primary outcome with other variables - clinical measures of motor function neuropsychiatric assessment will be examined EEG measures of movement related cortical potentials and MR imaging findings will be analyzed in an exploratory fashion to determine whether these measures differ between PLS and ALS patients
The goal of this study is to see whether patterns of cerebral cortex dysfunction differ in Primary lateral sclerosis PLS and amyotrophic lateral sclerosis ALS The function of several regions of the cerebral cortex will be assessed by clinical physiological and neuropsychological tests Magnetic resonance imaging will be carried out in a subset of patients to explore the correlation between functional and anatomical measures of these cortical areas
Study Population
30 patients with Primary lateral sclerosis who meet the diagnostic criteria for PLS proposed by Pringle and 30 patients with ALS who fulfill the revised El Escorial criteria for probable or definite ALS
30 healthy volunteers will be studied to provide training and practice in using the rating scales and to provide age-matched controls for EEG and imaging studies
Design
A screening examination will be carried out under protocol 01-N-0145 to determine eligibility Patients and caregivers will return for two or three visits for sessions of neuropsychological testing a structured clinical neuropsychiatric evaluation ratings of motor and clinical function and measurement of movement-related cortical potentials with EEG A subset of patients will undergo MRI scans for quantitative anatomical measures of cortical regions
Outcome Measures
The primary outcome will be the classification of patients as normal or abnormal on neuropsychological testing of frontal cortex function Correlations of the primary outcome with other variables - clinical measures of motor function neuropsychiatric assessment will be examined EEG measures of movement related cortical potentials and MR imaging findings will be analyzed in an exploratory fashion to determine whether these measures differ between PLS and ALS patients
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 |
|---|---|---|---|
| 06-N-0174 | None | None | None |