The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients

Study Overview
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Brief Summary
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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
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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?

Official Title
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The HEP-OKS Pilot Study - a Randomized Controlled Trial of Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients

Conditions
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Spatial Neglect, Cerebral Stroke

Intervention / Treatment
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* Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy. | |
| Experimental: HEP-OKS<br> | Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)<br>* Patients in this arm will wear standard spectacle frames containing noncorrective lenses to which right half-field patches are attached (hemifield eye patching, HEP). In case of patients already wearing prescribed glasses, the patches will be attached to their own glasses. The glasses will be worn all-day for the duration of the treatment phase (seven days) and only be removed for sleeping and face cleaning as well as for the duration of the daily OKS treatment sessions. Furthermore these patients will receive daily sessions (20 minutes) of optokinetic stimulation (OKS). Therefore patients will be seated in front of a widescreen monitor, watching a black background with a pattern of various objects (size 1°), which coherently and continuously move to the left at a velocity of 10 °/s.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score in a neglect test battery | 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 | Change from baseline at Day 8 (post-treatment) | 
| Functional independence score | Level of functional independence (score between 0 and 100%) as measured by the Barthel-Index and the Catherine-Bergego-Scale | Change from baseline at Day 8 (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance in paper-and-pencil subtests | The secondary outcome measures include scores of the individual subtests of the neglect test battery, i.e. bells and star cancellation tasks, line bisection, figure copying and text reading. | Change from baseline at Day 8 and at Day 30 | 
| Performance in computerized attention tests | Performance in two computerized attention tests. These comprise a Posner Attention Task and a visual search task including eye movement analyses. | Change from baseline at Day 8 and at Day 30 | 
| MRI | All patients (without contraindications) undergo cranial Magnetic Resonance Imaging (MRI) including 3D lesion analysis, resting state fMRI and a task-related fMRI with optokinetic stimuli. Patients' MRI data will be correlated to behavioural performance (see primary and other secondary outcome measures) and will also be compared to controls without spatial neglect. | Day 1 | 
| Total score in the neglect test battery at follow-up | For details please see primary outcome measure | Change from baseline at Day 30 | 
| Functional independence score at follow-up | For details please see primary outcome measure | Change from baseline at Day 30 |