Clinical trial NCT01617343: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spatial Neglect
Cerebral Stroke
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2012-06-12
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Total score in a neglect test battery
timeFrame: Change from baseline at Day 8 (post-treatment)
measure: Functional independence score
timeFrame: Change from baseline at Day 8 (post-treatment)
Secondary outcomes:
measure: Performance in paper-and-pencil subtests
timeFrame: Change from baseline at Day 8 and at Day 30
measure: Performance in computerized attention tests
timeFrame: Change from baseline at Day 8 and at Day 30
measure: MRI
timeFrame: Day 1
measure: Total score in the neglect test battery at follow-up
timeFrame: Change from baseline at Day 30
measure: Functional independence score at follow-up
timeFrame: Change from baseline at Day 30
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University of Luebeck, Dept. of Neurology
state: Schleswig-Holstein
Study officials:
affiliation: University of Luebeck
name: Bjoern Machner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.