The HEP-OKS Pilot Study - a Randomized Controlled Trial of Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Spatial Neglect
- Sponsor
- University of Luebeck
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Total score in a neglect test battery
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Spatial neglect represents one of the major cognitive disorders following stroke. Patients patients fail to be aware of objects or people to their left and orientate instead to their right side. Enduring neglect has been found to be a poor prognostic indicator for functional independence following stroke. Despite some promising experimental accounts there are no established treatments for this condition.
The aim of this study is to test whether a combined treatment with hemifield eye patching (HEP) and optokinetic stimulation (OKS) can permanently reduce neglect behaviour and improve functional outcome in patients with hemispatial neglect following stroke.
The investigators hypothesise that the treatment with HEP and OKS will lead to a greater reduction of neglect scoring in the neglect test battery as well as a greater improvement in functional independence scores as compared to the spontaneous clinical course of the usual-care control group.
Detailed Description
To specify, this study should answer the following main question: Does the daily wearing of hemifield eye patches over a period of 1 week in combination with daily sessions of optokinetic stimulation lead to a significant reduction of neglect behaviour as measured by total scores in a paper-and-pencil neglect test battery and/or an improvement in functional independence scores (Catherine-Bergego-Scale, Barthel Index) in a cohort of stroke patients with acute hemispatial neglect as compared to the spontaneous course of the disease in a control patient group without a neglect-specific treatment?
Investigators
Bjoern Machner
MD, Principal Investigator
University of Luebeck
Eligibility Criteria
Inclusion Criteria
- •Right hemisphere stroke
- •Spatial neglect as determined by pathological scores in at least two tests of a neglect test battery (Azouvi et al., JNNP, 2004)
- •Age \> 18 years old
- •Informed consent signature
Exclusion Criteria
- •Bilateral or previous unilateral stroke lesions
- •Pre-existing neurodegenerative disease
- •Inability to give informed consent
Outcomes
Primary Outcomes
Total score in a neglect test battery
Time Frame: Change from baseline at Day 8 (post-treatment)
Performance in a neglect test battery (score between 0 and 100%) consisting of standard neglect tests including two cancellation tasks, line bisection, figure copying and text reading
Functional independence score
Time Frame: Change from baseline at Day 8 (post-treatment)
Level of functional independence (score between 0 and 100%) as measured by the Barthel-Index and the Catherine-Bergego-Scale
Secondary Outcomes
- Total score in the neglect test battery at follow-up(Change from baseline at Day 30)
- Functional independence score at follow-up(Change from baseline at Day 30)
- Performance in paper-and-pencil subtests(Change from baseline at Day 8 and at Day 30)
- Performance in computerized attention tests(Change from baseline at Day 8 and at Day 30)
- MRI(Day 1)