We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01617343
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Spatial Neglect Cerebral Stroke Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS) Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The HEP-OKS Pilot Study - a Randomized Controlled Trial of Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Study Start Date : August 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

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.



Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617343


Locations
Germany
University of Luebeck, Dept. of Neurology
Luebeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University of Luebeck
German Research Foundation
Investigators
Principal Investigator: Bjoern Machner, MD University of Luebeck
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bjoern Machner, MD, Principal Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01617343     History of Changes
Other Study ID Numbers: HEP-OKS-01
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms