The HEP-OKS Study - Hemifield Eye Patching and Optokinetic Stimulation to Treat Hemispatial Neglect in Stroke Patients
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|ClinicalTrials.gov Identifier: NCT01617343|
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : April 8, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
No Intervention: Usual care
Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.
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.
- 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
- 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
- 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.
- 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.
- 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.
- 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
- Functional independence score at follow-up [ Time Frame: Change from baseline at Day 30 ]For details please see primary outcome measure
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
|University of Luebeck, Dept. of Neurology|
|Luebeck, Schleswig-Holstein, Germany, 23538|
|Principal Investigator:||Bjoern Machner, MD||University of Luebeck|