Neglect, HemispatialNCT03451708
OKS for the Treatment of Hemispatial Neglect
A study testing OKS in people with Neglect, Hemispatial and Neglect, Sensory, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neglect, Hemispatial, Neglect, Sensory, Neglect, Hemisensory
- What is being tested?
- OKS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 Mar 2023
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test
Who cannot join
- Reduced vision
- Documented vestibular disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.
- Conditions
- Neglect, Hemispatial, Neglect, Sensory, Neglect, Hemisensory
- Being tested
- OKS
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OKSDevice
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.
| Study group | Role | What they receive |
|---|---|---|
| Optimization of OKS | Experimental | Crossover study examining various OKS protocols on improving symptoms of hemispatial neglect Receives: Device: OKS |
| Safety and efficacy study | Experimental | Randomized study assessing the safety and efficacy of OKS in treating hemispatial neglect Receives: Device: OKS |
| Effect of repetitive stimulation | Experimental | Benefits of daily, repetitive OKS in treating hemispatial neglect Receives: Device: OKS |
| OKS and gait | Experimental | Effect of OKS on gait and balance Receives: Device: OKS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemispatial neglect scores
Performance on Center of Cancellation Test
Measured: After 1 hour of OKS
Change in Hemispatial neglect scores
Performance on Behavioral Inattention Test
Measured: After 1 hour of OKS
Effect of OKS on vision
visual acuity
Measured: After 1 hour of OKS
Effect of OKS on vision
reading speed
Measured: After 1 hour of OKS
Secondary outcomes (5)
Changes in secondary hemispatial neglect scores
Line bisection score
Measured: After 1 hour of OKS
Changes in secondary hemispatial neglect scores
grip strength
Measured: After 1 hour of OKS
Changes in secondary hemispatial neglect scores
extinction score
Measured: After 1 hour of OKS
Effect of OKS on gait
Gait assessment
Measured: After 1 hour of OKS
Effect of OKS on gait
Balance assessments
Measured: After 1 hour of OKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 May 2018
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Enrollment and other trial activities were halted by COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neglect, HemispatialStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Eye Institute (NEI)
- Responsible party
- Principal investigator, Chun Lim, Beth Israel Deaconess Medical Center
- Investigators
- Chun Lim, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451708
- Sponsor's protocol ID
- 2016P000396
- Other IDs
- R21EY027468
- Status last verified
- Jun 2024
- First submitted
- 8 Feb 2018
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34196963
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
- ClinicalTrials.gov ID
- NCT03451708
- Acronym / sponsor ID
- 2016P000396
- Conditions
- Neglect, Hemispatial, Neglect, Sensory, Neglect, Hemisensory
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment and other trial activities were halted by COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Eye Institute (NEI)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 2 Mar 2018 (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.
Hemispatial neglect is a disorder where the patient has difficulty attending to objects and information in the left side of space, which occurs following strokes to the right side of the brain. This project is designed to help us understand how optokinetic stimulation treats the symptoms of hemispatial neglect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Optimization of OKS | Experimental | Device: OKSCrossover study examining various OKS protocols on improving symptoms of hemispatial neglect |
| Safety and efficacy study | Experimental | Device: OKSRandomized study assessing the safety and efficacy of OKS in treating hemispatial neglect |
| Effect of repetitive stimulation | Experimental | Device: OKSBenefits of daily, repetitive OKS in treating hemispatial neglect |
| OKS and gait | Experimental | Device: OKSEffect of OKS on gait and balance |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test
Key exclusion criteria (2 listed)
- Reduced vision
- Documented vestibular disorder
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 |
|---|---|---|
| OKSOptokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects. | Device | Effect of repetitive stimulation, OKS and gait, Optimization of OKS, Safety and efficacy study |
Primary outcome
Change in Hemispatial neglect scores
Time frame: After 1 hour of OKS
Performance on Center of Cancellation Test
Change in Hemispatial neglect scores
Time frame: After 1 hour of OKS
Performance on Behavioral Inattention Test
Effect of OKS on vision
Time frame: After 1 hour of OKS
visual acuity
Effect of OKS on vision
Time frame: After 1 hour of OKS
reading speed
5 secondary outcomes
Changes in secondary hemispatial neglect scores
Time frame: After 1 hour of OKS
Changes in secondary hemispatial neglect scores
Time frame: After 1 hour of OKS
Changes in secondary hemispatial neglect scores
Time frame: After 1 hour of OKS
Effect of OKS on gait
Time frame: After 1 hour of OKS
Effect of OKS on gait
Time frame: After 1 hour of OKS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- 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: Undecided
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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.
Chun Lim, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OKS in people with Neglect, Hemispatial and Neglect, Sensory, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Jun 2024. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Hemispatial neglect scores (time frame: After 1 hour of OKS). The study lists 4 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 NCT03451708, which also lists 1 linked publication.
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 5 Jun 2024.