Spatial NeglectOKS-READNCT04273620
Combined Optokinetic Stimulation and Cueing-based Reading Therapy to Treat Hemispatial Neglect Following Stroke
A study testing Optokinetic stimulation and cueing-based reading therapy (OKS-READ) and General neuropsychological treatment in people with Spatial Neglect, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spatial Neglect
- What is being tested?
- Optokinetic stimulation and cueing-based reading therapy (OKS-READ) and General neuropsychological treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jan 2020to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University of Luebeck, Dept. of Neurology
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Randomized Controlled Trial of Combined Optokinetic Stimulation and Cueing-based Reading Therapy to Treat Hemispatial Neglect Following Stroke (OKS-READ Study)
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.
Read the detailed description
see above
- Conditions
- Spatial Neglect
- Being tested
- Optokinetic stimulation and cueing-based reading therapy (OKS-READ), General neuropsychological treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optokinetic stimulation and cueing-based reading therapy (OKS-READ)Behavioural
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).
General neuropsychological treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ); Behavioral: General neuropsychological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Performance in the Menu reading task of the Behavioural Inattention Test battery (minimum 0 correct words (worst outcome), maximum 24 correct words (best outcome)
Measured: 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
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)
Measured: 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
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)
Measured: 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
Difference between investigator-assessed CBS score and the patient's self-assessed CBS score
Measured: 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)
Barthel Index (min. 0, max. 100, higher score means better outcome)
Measured: 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 (FIM)
Functional Independence Measure (18 items scale with scores between 0 and 7 points; higher scores mean better outcome)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start22 Jan 2020
- Primary completion21 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bjoern Machner, University of Luebeck
- Investigators
- Bjoern Machner, MD, Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273620
- Sponsor's protocol ID
- ULuebeck
- Acronym
- OKS-READ
- Status last verified
- May 2022
- First submitted
- 7 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36645965Longley 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.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Combined Optokinetic Stimulation and Cueing-based Reading Therapy to Treat Hemispatial Neglect Following Stroke (OKS-READ Study)
- ClinicalTrials.gov ID
- NCT04273620
- Acronym / sponsor ID
- OKS-READ / ULuebeck
- Conditions
- Spatial Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention-Control (IC) | Experimental | Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ), Behavioral: General neuropsychological treatmentIn 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) | Active comparator | Behavioral: Optokinetic stimulation and cueing-based reading therapy (OKS-READ), Behavioral: General neuropsychological treatmentIn 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optokinetic stimulation and cueing-based reading therapy (OKS-READ)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). | Behavioural | Control-Intervention (CI), Intervention-Control (IC) |
| General neuropsychological treatmentAs 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. | Behavioural | Control-Intervention (CI), Intervention-Control (IC) |
Primary outcome
Neglect symptom severity (neuropsychological test performance)
Time frame: 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)
Neglect-related functional disability
Time frame: 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)
6 secondary outcomes
Neglect dyslexia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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 (FIM)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 36645965Bode 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.
- Derived from this study: PubMed 34196963Longley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjoern Machner, MD principal investigator
University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optokinetic stimulation and cueing-based reading therapy (OKS-READ) and General neuropsychological treatment in people with Spatial Neglect, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neglect symptom severity (neuropsychological test performance) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273620, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.