Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect
Recruitment status was Not yet recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 21, 2006 | ||||
| Last Updated Date | June 2, 2010 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. | ||||
| Original Primary Outcome Measures ICMJE |
This study’s aim is to examine the functional re-organization of attentional network in the brain of USN patients while performing visual tasks, by means of functional neuro-imaging techniques, in light of specific rehabilitation technique. | ||||
| Change History | Complete list of historical versions of study NCT00305513 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. | ||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of Rehabilitation on the Recovery of Patients Post Right Stroke With Unilateral Spatial Neglect | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Procedure: Inclusion criteria:
Participants:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: The phasic alerting treatment | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 6 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00305513 | ||||
| Other Study ID Numbers ICMJE | 10-17.02.06-HMO-CTIL | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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