Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001783
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Motor Recovery in Recent Stroke Patients Treated With Amphetamine and Physical Therapy
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neuroanatomical and Neurophysiological Basis of Motor Recovery Associated With Treatment of Recent Stroke Using Amphetamine and Physical Therapy
Status:
COMPLETED
Status Verified Date:
2004-06
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:
The purpose of this study is to determine if giving amphetamines along with standard rehabilitation speeds motor recovery after a stroke In addition if motor recovery is improved the study will also identify the areas of the brain involved with the recovery
Researchers will use motor function ratings PET scans functional MRI fMRI electroencephalographs and transcranial magnetic stimulation TMS to evaluate patients
Patients participating in the study will be placed in one of two groups
1 Patients receiving dextroamphetamine and routine Rehabilitation Medicine
2 Patients receiving a placebo sugar pill and routine Rehabilitation Medicine
Patients that have improved motor recovery will undergo neuroimaging and neurophysiological studies to identify areas of the brain involved
Researchers will use motor function ratings PET scans functional MRI fMRI electroencephalographs and transcranial magnetic stimulation TMS to evaluate patients
Patients participating in the study will be placed in one of two groups
1 Patients receiving dextroamphetamine and routine Rehabilitation Medicine
2 Patients receiving a placebo sugar pill and routine Rehabilitation Medicine
Patients that have improved motor recovery will undergo neuroimaging and neurophysiological studies to identify areas of the brain involved
Detailed Description:
The purpose of this study is to determine if administration of dextroamphetamine amph linked with customarily used Rehabilitation Medicine accelerates motor recovery after stroke Additionally if motor recovery occurs this study will allow identification of the brain regions activated in association with this recovery
Techniques used will include longitudinal rating of motor function neuro-imaging with positron emission tomography PET and functional magnetic resonance tomography fMRI electroencephalography EEG and transcranial magnetic stimulation TMS Patients will be assigned to one of the two groups amph linked with PT and placebo linked with PT Every patient will receive the standard of care PT Motor recovery will be evaluated in the two groups If motor recovery is accelerated in any of the groups then neuroimaging and neurophysiological data will allow identification of areas and networks in the brain associated with this recovery
This is a Phase II study with potential major impact on how stroke patients are treated
Techniques used will include longitudinal rating of motor function neuro-imaging with positron emission tomography PET and functional magnetic resonance tomography fMRI electroencephalography EEG and transcranial magnetic stimulation TMS Patients will be assigned to one of the two groups amph linked with PT and placebo linked with PT Every patient will receive the standard of care PT Motor recovery will be evaluated in the two groups If motor recovery is accelerated in any of the groups then neuroimaging and neurophysiological data will allow identification of areas and networks in the brain associated with this recovery
This is a Phase II study with potential major impact on how stroke patients are treated
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 |
|---|---|---|---|
| 98-N-0115 | None | None | None |