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

Completed

Phase 3 Results N/A

Trial Description

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?

Conditions

Interventions

  • Hemifield eye patching (HEP) + optokinetic stimulation (OKS) Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: HEP-OKS

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Total score in a neglect test battery Change from baseline at Day 8 (post-treatment) No
Primary Functional independence score Change from baseline at Day 8 (post-treatment) No
Secondary Performance in paper-and-pencil subtests Change from baseline at Day 8 and at Day 30 No
Secondary Performance in computerized attention tests Change from baseline at Day 8 and at Day 30 No
Secondary MRI Day 1 No
Secondary Total score in the neglect test battery at follow-up Change from baseline at Day 30 No
Secondary Functional independence score at follow-up Change from baseline at Day 30 No

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