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

NCT00305513 | Unknown Phase 2

• 1 other identifier: 10-17.02.06-HMO-CTIL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident; Perceptual Disorders

Keywords

right hemispheric CVA; neglect; phasic alert treatment; PET scan; patients post right hemispheric CVA (stroke)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

The phasic alerting treatment PROCEDURE

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First time right hemispheric stroke (ischemic)
• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Stroke; Perceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zeev Meiner, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeev Meiner, MD

CONTACT

00 972 2 5844582; MEINER@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Last Updated: June 3, 2010

Record last verified: 2006-03

Locations

IL (1)