Combined Optokinetic Stimulation and Cueing-based Reading Therapy to Treat Hemispatial Neglect Following Stroke

Not Applicable

Completed

• Conditions: Spatial Neglect
• Interventions: Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ); Behavioral: General neuropsychological treatment

• Registration Number: NCT04273620
• Lead Sponsor: University of Luebeck

Brief Summary

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.

Detailed Description

see above

Study Timeline

• Study Start: 2020-01-22
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-18
• Primary Completion: 2022-01-21
• Study Completion: 2022-02-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention-Control (IC)	General neuropsychological treatment	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).
Control-Intervention (CI)	General neuropsychological treatment	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).
Intervention-Control (IC)	Optokinetic stimulation and cueing-based reading therapy (OKS-READ)	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).
Control-Intervention (CI)	Optokinetic stimulation and cueing-based reading therapy (OKS-READ)	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).

Primary Outcome Measures

Name	Time	Method
Neglect-related functional disability	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Clinical score of neglect-related functional disability (Catherine Bergego Scale, CBS; minimum 0, maximum 30, higher score means worse outcome)
Neglect symptom severity (neuropsychological test performance)	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Composite score of different established computerized tests assessing spatial neglect (minimum 0%, maximum 100%, higher score means better outcome)

Secondary Outcome Measures

Name	Time	Method
Oculomotor bias during visual exploration	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	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)
Anosognosia	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Difference between investigator-assessed CBS score and the patient's self-assessed CBS score
Non-neglect specific functional outcome (Barthel)	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Barthel Index (min. 0, max. 100, higher score means better outcome)
Neglect dyslexia	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Performance in the Menu reading task of the Behavioural Inattention Test battery (minimum 0 correct words (worst outcome), maximum 24 correct words (best outcome)
Functional Independence (FIM)	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	Functional Independence Measure (18 items scale with scores between 0 and 7 points; higher scores mean better outcome)
Attention bias during a visuo-motor cancellation task	Intra-individual difference of the outcome's change during 3 weeks Intervention versus 3 weeks Control phase, i.e. (T3 on Day 21 - T2 on Day 1) - (T5 on Day 42 - T4 on Day 22)	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)

Trial Locations

Locations (1)

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