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

Cerebrovascular Accident Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00305513
• Other study ID #: 10-17.02.06-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 21, 2006
• Last updated: June 2, 2010

Study information

• Verified date: March 2006
• Source: Hadassah Medical Organization
• Contact: Zeev Meiner, MD
• Phone: 00 972 2 5844582
• Email: MEINER[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Perceptual Disorders
• Stroke

Intervention

Procedure:
• The phasic alerting treatment

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.