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

Cerebral Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617343
• Other study ID #: HEP-OKS-01
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2012
• Last updated: April 7, 2014
• Start date: August 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Stroke
• Spatial Neglect
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	University of Luebeck, Dept. of Neurology	Luebeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline at Day 8 (post-treatment)	No
Primary	Functional independence score	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)	No
Secondary	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.	Change from baseline at Day 8 and at Day 30	No
Secondary	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.	Change from baseline at Day 8 and at Day 30	No
Secondary	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.	Day 1	No
Secondary	Total score in the neglect test battery at follow-up	For details please see primary outcome measure	Change from baseline at Day 30	No
Secondary	Functional independence score at follow-up	For details please see primary outcome measure	Change from baseline at Day 30	No