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Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect
This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, March 2006
Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00305513
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Perceptual Disorders
Procedure: The phasic alerting treatment
Phase II

MedlinePlus related topics: Nuclear Scans Rehabilitation
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Hadassah Medical Organization:

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.

Estimated Enrollment: 6
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.

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305513

Contacts
Contact: Zeev Meiner, MD 00 972 2 5844582 MEINER@hadassah.org.il

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Zeev Meiner, MD Hadassah Medical Organization
  More Information

No publications provided

Study ID Numbers: 10-17.02.06-HMO-CTIL
Study First Received: March 21, 2006
Last Updated: September 4, 2007
ClinicalTrials.gov Identifier: NCT00305513  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
right hemispheric CVA
neglect
phasic alert treatment
PET scan
patients post right hemispheric CVA (stroke)

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Brain Ischemia
Brain Infarction
Infarction
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009