Combined Optokinetic Stimulation and Cueing-based Reading Therapy to Treat Hemispatial Neglect Following Stroke (OKS-READ)

University of Luebeck

Status: Completed

Conditions: Spatial Neglect

Treatments: Behavioral: General neuropsychological treatment; Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ)

Study type: Interventional

Funder types: Other

Identifiers

NCT04273620

ULuebeck

Details and patient eligibility

About

Spatial neglect represents a common and severe cognitive disorder following unilateral (mostly right hemisphere) stroke. Patients are unaware of objects, persons and even own body parts in the (usually left) hemispace opposite to their brain lesion. While there is spontaneous remission in some patients, neglect symptoms persist in many stroke survivors which is associated with a poor functional outcome. Although different therapeutic approaches (including cognitive interventions, non-invasive brain stimulation and drugs) have been investigated in the last decades, an established therapy is still missing. Hence, there is a clear need for an effective and feasible intervention that can be applied in rehabilitation centers.

This study is dedicated to assess the effect of a cognitive treatment consisting of combined optokinetic stimulation (OKS) and cueing-based reading therapy (READ) on hemispatial neglect and the neglect-related functional disability in right-hemisphere stroke patients. It will be a mono-centric, randomized, controlled, clinical trial. Using a crossover design with two arms, patients will either receive the intervention therapy (OKS-READ) first and subsequently the control treatment (neuropsychological training not targeting visuospatial attention) or they will start in the control arm and then switch to the intervention. Each treatment phase consists of 15 therapy sessions lasting 30 to 45 minutes. The outcome will be assessed at different time points, including established neuropsychological tests for spatial neglect and a clinical score of neglect-related functional disability.

Full description

see above

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• a first-time stroke in the right hemisphere (confirmed by cranial CT or MRI) within the last six months,
• a left-sided hemispatial neglect (as detected in at least one subtest of the neuropsychological test battery at screening),
• the ability to read and understand German language and
• the ability to give informed consent.

Exclusion criteria

• dementia
• other structural brain lesions besides the unilateral stroke (e.g. multiple or bilateral stroke lesions, hydrocephalus, inflammatory lesions, etc.)
• low vision (corrected <0.7) due to ophthalmological diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Intervention-Control (IC)

Experimental group

Description:

In the Intervention-Control (IC) arm, patients will first receive the intervention (OKS-READ) containing 15 individual therapy sessions within a maximum time period of 28 days. Afterwards they will receive the control therapy (again 15 sessions within max. 28 days).

Treatment:

Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ)

Behavioral: General neuropsychological treatment

Control-Intervention (CI)

Active Comparator group

Description:

In the Control-Intervention (CI) arm, patients will first receive the control therapy (15 sessions within max. 28 days), followed by the intervention phase (15 therapy sessions OKS-READ within a maximum time period of 28 days).

Treatment:

Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ)

Behavioral: General neuropsychological treatment