The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
Primary Purpose
Spatial Neglect, Cerebral Stroke
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
hemifield eye patching (HEP) + optokinetic stimulation (OKS)
Sponsored by
About this trial
This is an interventional treatment trial for Spatial Neglect
Eligibility 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
Sites / Locations
- University of Luebeck, Dept. of Neurology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
HEP-OKS
Arm Description
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
Outcomes
Primary Outcome Measures
Total score in a neglect test battery
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
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
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
Performance in two computerized attention tests. These comprise a Posner Attention Task and a visual search task including eye movement analyses.
MRI
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
For details please see primary outcome measure
Functional independence score at follow-up
For details please see primary outcome measure
Full Information
NCT ID
NCT01617343
First Posted
June 5, 2012
Last Updated
April 7, 2014
Sponsor
University of Luebeck
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01617343
Brief Title
The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. 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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spatial Neglect, Cerebral Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
Arm Title
HEP-OKS
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
hemifield eye patching (HEP) + optokinetic stimulation (OKS)
Intervention Description
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 Outcome Measure Information:
Title
Total score in a neglect test battery
Description
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
Time Frame
Change from baseline at Day 8 (post-treatment)
Title
Functional independence score
Description
Level of functional independence (score between 0 and 100%) as measured by the Barthel-Index and the Catherine-Bergego-Scale
Time Frame
Change from baseline at Day 8 (post-treatment)
Secondary Outcome Measure Information:
Title
Performance in paper-and-pencil subtests
Description
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.
Time Frame
Change from baseline at Day 8 and at Day 30
Title
Performance in computerized attention tests
Description
Performance in two computerized attention tests. These comprise a Posner Attention Task and a visual search task including eye movement analyses.
Time Frame
Change from baseline at Day 8 and at Day 30
Title
MRI
Description
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.
Time Frame
Day 1
Title
Total score in the neglect test battery at follow-up
Description
For details please see primary outcome measure
Time Frame
Change from baseline at Day 30
Title
Functional independence score at follow-up
Description
For details please see primary outcome measure
Time Frame
Change from baseline at Day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjoern Machner, MD
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Luebeck, Dept. of Neurology
City
Luebeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24923723
Citation
Machner B, Konemund I, Sprenger A, von der Gablentz J, Helmchen C. Randomized controlled trial on hemifield eye patching and optokinetic stimulation in acute spatial neglect. Stroke. 2014 Aug;45(8):2465-8. doi: 10.1161/STROKEAHA.114.006059. Epub 2014 Jun 12.
Results Reference
derived
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The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
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