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

NCT04273620 | Completed

• 1 other identifier: ULuebeck
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Spatial Neglect

Outcome Measures

Primary Outcomes (2)

• Neglect symptom severity (neuropsychological test performance)

  Composite score of different established computerized tests assessing spatial neglect (minimum 0%, maximum 100%, higher score means better outcome)

  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)

• Neglect-related functional disability

  Clinical score of neglect-related functional disability (Catherine Bergego Scale, CBS; minimum 0, maximum 30, higher score means worse outcome)

  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)

Secondary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Intervention-Control (IC)

EXPERIMENTAL

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).

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

Control-Intervention (CI)

ACTIVE COMPARATOR

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).

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

Interventions

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

Each intervention session starts with an 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 the patients. Patients are instructed to choose one 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 the patient 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 were omitted) and endogenous cues (verbal instructions which require intrinsic action by the patient) to facilitate attentional shifts to the left. The intensity of cueing will be matched to the actual severity of neglect (adaptive therapy).

Control-Intervention (CI); Intervention-Control (IC)

General neuropsychological treatment BEHAVIORAL

As a control treatment the 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.

Control-Intervention (CI); Intervention-Control (IC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Luebeck: lead

Study Sites (1)

University of Luebeck, Dept. of Neurology

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (2)

• Bode LKG, Sprenger A, Helmchen C, Hauptmann B, Munte TF, Machner B. Combined optokinetic stimulation and cueing-assisted reading therapy to treat hemispatial neglect: A randomized controlled crossover trial. Ann Phys Rehabil Med. 2023 Jun;66(5):101713. doi: 10.1016/j.rehab.2022.101713. Epub 2023 Jan 14.

  PMID: 36645965 DERIVED

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

  PMID: 34196963 DERIVED

Study Officials

• Bjoern Machner, MD

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Due to the implicit constraints of cognitive interventions (no placebo possible as opposed to drug studies), neither the patient himself nor the therapist of the study can be blinded to the patient's allocation arm. However, the assessment of the functional impairment will be performed by rehabilitation staff who are blind to the patient's allocation. Furthermore, the assessment of neglect severity by use of a computerized neuropsychological test battery is robust and objective and largely independent of the investigator who is administering the test.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant Neurologist

Model Details: This study will be a mono-centric, randomized, controlled, clinical trial. Using a crossover design with two arms, patients will either receive the intervention therapy first and then the control treatment or they will start in the control arm and then switch to the intervention.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 18, 2020
• Study Start: January 22, 2020
• Primary Completion: January 21, 2022
• Study Completion: February 1, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)