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NCT Number: NCT01617343

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

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.

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Key information

Conditions

Spatial Neglect Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Stroke Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Luebeck, Dept. of Neurology

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hemifield eye patching (HEP) + optokinetic stimulation (OKS)

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  1. Performance in paper-and-pencil subtests

    Time frame: Change from baseline at Day 8 and at Day 30

    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.

  2. Performance in computerized attention tests

    Time frame: Change from baseline at Day 8 and at Day 30

    Performance in two computerized attention tests. These comprise a Posner Attention Task and a visual search task including eye movement analyses.

  3. MRI

    Time frame: Day 1

    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.

  4. Total score in the neglect test battery at follow-up

    Time frame: Change from baseline at Day 30

    For details please see primary outcome measure

  5. Functional independence score at follow-up

    Time frame: Change from baseline at Day 30

    For details please see primary outcome measure

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2012
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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