Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080600
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-04-07
Brief Title:
Brain Physiology in Polio Survivors
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Central Motor Physiology in Polio Survivors
Status:
COMPLETED
Status Verified Date:
2007-12-10
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 Many persons who survive poliomyelitis develop pain weakness and fatigue many decades later It is not known why some persons develop this syndrome and others do not One possibility is that polio caused subclinical damage to the motor cortex Autopsies in some polio patients have found damage to the brainstem and motor cortex as well as to spinal motor neurons Alternatively polio may have spared the motor cortex but the cortex reorganized in different ways to compensate for the loss of spinal motor neurons This study will first assess the integrity of central motor pathways in polio survivors with and without postpolio syndrome The second goal will be to investigate differences in the intracortical mechanisms for controlling muscles affected and unaffected by polio
STUDY POPULATION 60 patients who survived polio in childhood Only patients with an unequivocal history of polio will be referred to this study Half of the patients will have the post-polio syndrome 30 normal volunteers aged 21-75
DESIGN Patients will be screened at the collaborating institution the Uniformed Services University of the Health Sciences which will also perform sensory evoked potential testing and MRI At NIH motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation Two muscles will be tested in each patient one affected by polio and one unaffected by polio In the affected muscle intracortical facilitation will be assessed again after exercises it until it fatigues
OUTCOME PARAMETERS Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome
STUDY POPULATION 60 patients who survived polio in childhood Only patients with an unequivocal history of polio will be referred to this study Half of the patients will have the post-polio syndrome 30 normal volunteers aged 21-75
DESIGN Patients will be screened at the collaborating institution the Uniformed Services University of the Health Sciences which will also perform sensory evoked potential testing and MRI At NIH motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation Two muscles will be tested in each patient one affected by polio and one unaffected by polio In the affected muscle intracortical facilitation will be assessed again after exercises it until it fatigues
OUTCOME PARAMETERS Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome
Detailed Description:
OBJECTIVE Many persons who survive poliomyelitis develop pain weakness and fatigue many decades later It is not known why some persons develop this syndrome and others do not One possibility is that polio caused subclinical damage to the motor cortex Autopsies in some polio patients have found damage to the brainstem and motor cortex as well as to spinal motor neurons Alternatively polio may have spared the motor cortex but the cortex reorganized in different ways to compensate for the loss of spinal motor neurons This study will first assess the integrity of central motor pathways in polio survivors with and without postpolio syndrome The second goal will be to investigate differences in the intracortical mechanisms for controlling muscles affected and unaffected by polio
STUDY POPULATION 60 patients who survived polio in childhood Only patients with an unequivocal history of polio will be referred to this study Half of the patients will have the post-polio syndrome 30 normal volunteers aged 21-80
DESIGN Patients will be screened at the collaborating institution the Uniformed Services University of the Health Sciences which will also perform sensory evoked potential testing At NIH motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold MRI scans of the brain or spine will be performed in patients with abnormal evoked potentials Intracortical facilitation will be assessed using paired-pulse magnetic stimulation Two muscles will be tested in each patient one affected by polio and one unaffected by polio In the affected muscle intracortical facilitation will be assessed again after exercises it until it fatigues
OUTCOME PARAMETERS Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome
STUDY POPULATION 60 patients who survived polio in childhood Only patients with an unequivocal history of polio will be referred to this study Half of the patients will have the post-polio syndrome 30 normal volunteers aged 21-80
DESIGN Patients will be screened at the collaborating institution the Uniformed Services University of the Health Sciences which will also perform sensory evoked potential testing At NIH motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold MRI scans of the brain or spine will be performed in patients with abnormal evoked potentials Intracortical facilitation will be assessed using paired-pulse magnetic stimulation Two muscles will be tested in each patient one affected by polio and one unaffected by polio In the affected muscle intracortical facilitation will be assessed again after exercises it until it fatigues
OUTCOME PARAMETERS Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome
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 |
|---|---|---|---|
| 04-N-0156 | None | None | None |