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

NCT01617343 | Completed Phase 3

• 1 other identifier: HEP-OKS-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Spatial Neglect; Cerebral Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (5)

• Performance in paper-and-pencil subtests

  Change from baseline at Day 8 and at Day 30

• Performance in computerized attention tests

  Change from baseline at Day 8 and at Day 30

• MRI

  Day 1

• Total score in the neglect test battery at follow-up

  Change from baseline at Day 30

• Functional independence score at follow-up

  Change from baseline at Day 30

Study Arms (2)

Usual care

NO INTERVENTION

Patients in this control group will receive usual care following stroke including standard physiotherapy and occupational therapy.

HEP-OKS

EXPERIMENTAL

Behavioral: hemifield eye patching (HEP) + optokinetic stimulation (OKS)

Interventions

hemifield eye patching (HEP) + optokinetic stimulation (OKS) BEHAVIORAL

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.

HEP-OKS

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Bilateral or previous unilateral stroke lesions
• Pre-existing neurodegenerative disease
• Inability to give informed consent

Sponsors & Collaborators

• University of Luebeck: lead
• German Research Foundation: collaborator

Study Sites (1)

University of Luebeck, Dept. of Neurology

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

• 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.

  PMID: 24923723 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bjoern Machner, MD

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 12, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

DE (1)