Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305513
Status:
UNKNOWN
Last Update Posted:
2010-06-03
First Post:
2006-03-21
Brief Title:
Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Effectiveness of Rehabilitation Phasic Alerting and Visual Spatial Scanning Training on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect Using Functional Imaging PET and Standardized Neurobehavioral and Functional Tests
Status:
UNKNOWN
Status Verified Date:
2006-03
Last Known Status:
NOT_YET_RECRUITING
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:
Unilateral spatial neglect USN is believed to be a disorder of attention characterized by impairment in the ability to perceive or respond to stimuli presented to the contralesional space and which is not attributable to significant sensory or motor deficits USN has serious consequences for rehabilitation and long term disabilities Efforts have been made to clarify both the theoretical basis of this phenomenon and the rehabilitation methods that will be best in improving function The purpose of this study is to try and contribute to both efforts by examining treatment effectiveness of two methods one targeting general arousal phasic alerting and the other targeting increasing awareness to left side stimuli and habit changes Functional neuroimaging methods PET positron emission tomography and fMRI functional magnetic resonance imaging have been applied to understand the functional anatomy of the brain during mental processes Only a few attempts have been made to use functional neuroimaging in patients with neurological deficits such as USN usually speculations are made based on findings with healthy participants to explain this disorder This studys aim is to examine the functional reorganization of the attentional network in the brain of USN patients while performing visual tasks by means of functional neuroimaging techniques in light of specific rehabilitation techniques
Patients will be examined before and after 3 weeks of rehabilitation both using standardized neurobehavioral tests and PET imaging procedures
Patients will be examined before and after 3 weeks of rehabilitation both using standardized neurobehavioral tests and PET imaging procedures
Detailed Description:
Procedure
Inclusion criteria
first time right hemispheric stroke ischemic
2-6 weeks post stroke incident
ages 25-85
right hand dominance
minimum education of 6 years
do not suffer from field cut deficit such as hemi-anopsia
without other known neurological disorders eg Parkinsons disease aphasia
without severe systemic conditions eg malignancies AIDS congestive heart failure substance abuse
did not take additional medications that could affect the central nervous system without dementia
without mental illness
the patients or their legal guardians have to give informed consent
Participants
six patients will be recruited and randomly allocated to one of the treatment groups phasic alerting or standard visual spatial training treatment provided in the OT department
Patients will undergo thorough evaluation of neglect and will undergo PET procedure before being transferred to rehabilitation Patient will receive intensive rehabilitation for 15 sessions of the cognitive treatment and 15 session of motor training After this period patient will undergo another PET procedure to assess any changes in brain activation Patient will then return to rehabilitation as needed
Inclusion criteria
first time right hemispheric stroke ischemic
2-6 weeks post stroke incident
ages 25-85
right hand dominance
minimum education of 6 years
do not suffer from field cut deficit such as hemi-anopsia
without other known neurological disorders eg Parkinsons disease aphasia
without severe systemic conditions eg malignancies AIDS congestive heart failure substance abuse
did not take additional medications that could affect the central nervous system without dementia
without mental illness
the patients or their legal guardians have to give informed consent
Participants
six patients will be recruited and randomly allocated to one of the treatment groups phasic alerting or standard visual spatial training treatment provided in the OT department
Patients will undergo thorough evaluation of neglect and will undergo PET procedure before being transferred to rehabilitation Patient will receive intensive rehabilitation for 15 sessions of the cognitive treatment and 15 session of motor training After this period patient will undergo another PET procedure to assess any changes in brain activation Patient will then return to rehabilitation as needed
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