NCT04273620.

Study name	Combined optokinetic stimulation and cueing‐based reading therapy to treat hemi‐spatial neglect following stroke (OKS‐READ)
Methods	This study will be a monocentric, randomised, controlled clinical trial. Using a cross‐over design with 2 arms, patients will receive the intervention therapy first, then the control treatment, or they will start in the control arm and will then switch to the intervention arm
Participants	Inclusion criteria First‐time stroke in the right hemisphere (confirmed by cranial CT or MRI) within the last 6 months Left‐sided hemi‐spatial neglect (as detected on at least 1 subtest of the neuropsychological test battery at screening) Ability to read and understand German language Ability to give informed consent Exclusion criteria Dementia Other structural brain lesions besides unilateral stroke (e.g. multiple or bilateral stroke lesions, hydrocephalus, inflammatory lesions) Low vision (corrected < 0.7) due to ophthalmological disease
Interventions	Behavioural: optokinetic stimulation and cueing‐based reading therapy (OKS‐READ) Each intervention session starts with optokinetic stimulation (OKS) of at least 15 minutes' duration. A pattern of squares, dots, triangles, and stars will coherently and continuously move to the left on a computer screen in front of patients. Patients are instructed to choose 1 stimulus and follow it with the eyes until it has reached the left side of the screen, then jump to the right edge of the screen and start again The second part of each intervention session is the cueing‐based reading therapy (READ), which will also last at least 15 minutes. The task of patients is to read out loud words or a text presented on a paper in front of them. We will use exogenous (e.g. the therapist highlights words when they are omitted) and endogenous cues (verbal instructions that require intrinsic action by patients) to facilitate attentional shifts to the left. The intensity of cueing will be matched to the actual severity of neglect (adaptive therapy) Behavioural: general neuropsychological treatment As a control treatment, patients will receive neuropsychological treatment without targeting visuospatial attention. Examples for components implemented are supporting conversations, diagnostic assessments (e.g. memory diagnostics), and training of memory and executive functions
Outcomes	Primary outcome measures Composite score of different established computerised tests assessing spatial neglect (minimum 0%, maximum 100%; higher score means better outcomes) Clinical score of neglect‐related functional disability (Catherine Bergego Scale, CBS; minimum 0, maximum 30; higher score means worse outcomes) Neglect symptom severity (neuropsychological test performance) [Time Frame: intraindividual difference of the outcome's change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Neglect‐related functional disability [Time Frame: intraindividual differences in outcome change during 3 weeks' Intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Secondary outcome measures Performance in the Menu reading task of the Behavioural Inattention Test battery (minimum 0 correct words (worst outcome), maximum 24 correct words (best outcome)) Bias of the Center of Cancellation (CoC) during the Bells test (values between ‐1 (strongest leftward bias), 0 (no bias), and +1 (strongest rightward bias)) Bias of the Center of Fixation (CoF) during free viewing of naturalistic photographs as measured with an infrared remote eye tracker (values between ‐1 (strongest leftward bias), 0 (no bias), and +1 (strongest rightward bias)) Differences between investigator‐assessed CBS score and patients' self‐assessed CBS score Barthel Index (minimum 0, maximum 100; higher score means better outcomes) Functional Independence Measure (18‐item scale with scores between 0 and 7 points; higher scores mean better outcomes) Neglect dyslexia [Time Frame: intraindividual differences in outcome change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Attention bias during visuomotor cancellation task [Time Frame: intraindividual difference in outcome change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Oculomotor bias during visual exploration [Time Frame: intraindividual difference in outcome's change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Anosognosia [Time Frame: intraindividual difference in outcome change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Non‐neglect‐specific functional outcome (Barthel) [Time Frame: intraindividual difference in outcome change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)] Functional Independence (FIM) [Time Frame: intraindividual difference in outcome change during 3 weeks' intervention phase vs 3 weeks' control phase, i.e. (T3 on Day 21 ‐ T2 on Day 1) ‐ (T5 on Day 42 ‐ T4 on Day 22)]
Starting date	22 January 2020
Contact information	bjoern.machner@neuro.uni-luebeck.de
Notes	End date: 21 February 2022