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

June 2, 2010 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization
        • Principal Investigator:
          • Zeev Meiner, MD
        • Principal Investigator:
          • Roland Chishin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Zeev Meiner, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 2, 2010

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-17.02.06-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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