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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00305513
First received: March 21, 2006
Last updated: June 2, 2010
Last verified: March 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Principal Investigator: Zeev Meiner, MD         
Principal Investigator: Roland Chishin, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Zeev Meiner, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00305513     History of Changes
Other Study ID Numbers: 10-17.02.06-HMO-CTIL
Study First Received: March 21, 2006
Last Updated: June 2, 2010
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)

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Perceptual Disorders
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014