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Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect

Primary Purpose

Cerebrovascular Accident, Perceptual Disorders

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
The phasic alerting treatment
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring right hemispheric CVA, neglect, phasic alert treatment, PET scan, patients post right hemispheric CVA (stroke)

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 The patients or their legal guardians have to give informed consent Does not suffer from field cut deficit such as hemi-anopsia Without other known neurological disorders (e.g., Parkinson's disease, aphasia) Without severe systemic conditions (e.g., malignancies, AIDS, congestive heart failure, substance abuse) Does not take additional medications that could affect the central nervous system Without dementia Without mental illness

Sites / Locations

  • Hadassah Medical Organization

Outcomes

Primary Outcome Measures

This study's 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.

Secondary Outcome Measures

The aim 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.

Full Information

First Posted
March 21, 2006
Last Updated
June 2, 2010
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00305513
Brief Title
Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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 study's 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.
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 (e.g., Parkinson's disease, aphasia); without severe systemic conditions (e.g., 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Perceptual Disorders
Keywords
right hemispheric CVA, neglect, phasic alert treatment, PET scan, patients post right hemispheric CVA (stroke)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
The phasic alerting treatment
Primary Outcome Measure Information:
Title
This study's 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.
Secondary Outcome Measure Information:
Title
The aim 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 The patients or their legal guardians have to give informed consent Does not suffer from field cut deficit such as hemi-anopsia Without other known neurological disorders (e.g., Parkinson's disease, aphasia) Without severe systemic conditions (e.g., malignancies, AIDS, congestive heart failure, substance abuse) Does not take additional medications that could affect the central nervous system Without dementia Without mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeev Meiner, MD
Phone
00 972 2 5844582
Email
MEINER@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeev Meiner, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Zeev Meiner, MD
First Name & Middle Initial & Last Name & Degree
Roland Chishin, MD

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect

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