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

Phase 3

Completed

• Conditions: Spatial Neglect; Cerebral Stroke
• Interventions: Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)

• Registration Number: NCT01617343
• Lead Sponsor: University of Luebeck

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?

Study Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Study Start: 2012-08
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEP-OKS	hemifield eye patching (HEP) + optokinetic stimulation (OKS)	-

Primary Outcome Measures

Name	Time	Method
Total score in a neglect test battery	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	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

Name	Time	Method
Total score in the neglect test battery at follow-up	Change from baseline at Day 30	For details please see primary outcome measure
Functional independence score at follow-up	Change from baseline at Day 30	For details please see primary outcome measure
Performance in paper-and-pencil subtests	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	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	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.

Trial Locations

Locations (1)

University of Luebeck, Dept. of Neurology; 🇩🇪 Luebeck, Schleswig-Holstein, Germany