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

April 7, 2014 updated by: Bjoern Machner, University of Luebeck

The HEP-OKS Pilot Study - a Randomized Controlled Trial of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23538
        • University of Luebeck, Dept. of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
Experimental: HEP-OKS
Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline at Day 8 (post-treatment)
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
Change from baseline at Day 8 (post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at Day 8 and at Day 30
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.
Change from baseline at Day 8 and at Day 30
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.
Day 1
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
Change from baseline at Day 30
Functional independence score at follow-up
Time Frame: Change from baseline at Day 30
For details please see primary outcome measure
Change from baseline at Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Bjoern Machner, MD, University of Luebeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEP-OKS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Stroke

Clinical Trials on hemifield eye patching (HEP) + optokinetic stimulation (OKS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe