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

This study is currently recruiting participants.
Verified August 2012 by University of Luebeck
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Bjoern Machner, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01617343
First received: June 5, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Spatial Neglect
Cerebral Stroke
 Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Total score in a neglect test battery [ Time Frame: Change from baseline at Day 8 (post-treatment) ] [ Designated as safety issue: No ]
    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

  • Functional independence score [ Time Frame: Change from baseline at Day 8 (post-treatment) ] [ Designated as safety issue: No ]
    Level of functional independence (score between 0 and 100%) as measured by the Barthel-Index and the Catherine-Bergego-Scale


Secondary Outcome Measures:
  • Performance in paper-and-pencil subtests [ Time Frame: Change from baseline at Day 8 and at Day 30 ] [ Designated as safety issue: No ]
    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.

  • Performance in computerized attention tests [ Time Frame: Change from baseline at Day 8 and at Day 30 ] [ Designated as safety issue: No ]
    Performance in two computerized attention tests. These comprise a Posner Attention Task and a visual search task including eye movement analyses.

  • MRI [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.

  • Total score in the neglect test battery at follow-up [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
    For details please see primary outcome measure

  • Functional independence score at follow-up [ Time Frame: Change from baseline at Day 30 ] [ Designated as safety issue: No ]
    For details please see primary outcome measure


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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?

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617343

Contacts
Contact: Bjoern Machner, MD +49(0)4515002492 Bjoern.Machner@neuro.uni-luebeck.de

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

No publications provided

Responsible Party: Bjoern Machner, MD, Principal Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01617343     History of Changes
Other Study ID Numbers: HEP-OKS-01
Study First Received: June 5, 2012
Last Updated: August 14, 2012
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on June 17, 2013