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WithdrawnNCT03451708Updated Jun 5, 2024

OKS for the Treatment of Hemispatial Neglect

An interventional study of OKS in Neglect, Hemispatial, Neglect, Sensory and Neglect, Hemisensory, sponsored by Beth Israel Deaconess Medical Center. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Enrollment and other trial activities were halted by COVID-19 pandemic.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Neglect, Hemispatial
  • Neglect, Sensory
  • Neglect, Hemisensory

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03

In context

Perceptual Disorders

66 studies on the registry are indexed under Perceptual Disorders; 21 are open to participants now.

Browse Perceptual Disorders studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.

Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.

Browse Beth Israel Deaconess Medical Center studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with right hemispheric lesions resulting in hemispatial neglect as confirmed by Behavioral Inattention Test or Center of Cancellation Test

Exclusion criteria

Exclusion Criteria:

  • Reduced vision
  • Documented vestibular disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Optimization of OKS

    Crossover study examining various OKS protocols on improving symptoms of hemispatial neglect

    Device: OKS

  • Experimental
    Safety and efficacy study

    Randomized study assessing the safety and efficacy of OKS in treating hemispatial neglect

    Device: OKS

  • Experimental
    Effect of repetitive stimulation

    Benefits of daily, repetitive OKS in treating hemispatial neglect

    Device: OKS

  • Experimental
    OKS and gait

    Effect of OKS on gait and balance

    Device: OKS

Interventions

  • DeviceOKS

    Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.

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What researchers measure

Primary outcomes

  1. Change in Hemispatial neglect scores

    Performance on Center of Cancellation Test

    Time frame: After 1 hour of OKS

  2. Change in Hemispatial neglect scores

    Performance on Behavioral Inattention Test

    Time frame: After 1 hour of OKS

  3. Effect of OKS on vision

    visual acuity

    Time frame: After 1 hour of OKS

  4. Effect of OKS on vision

    reading speed

    Time frame: After 1 hour of OKS

Secondary outcomes

  1. Changes in secondary hemispatial neglect scores

    Line bisection score

    Time frame: After 1 hour of OKS

  2. Changes in secondary hemispatial neglect scores

    grip strength

    Time frame: After 1 hour of OKS

  3. Changes in secondary hemispatial neglect scores

    extinction score

    Time frame: After 1 hour of OKS

  4. Effect of OKS on gait

    Gait assessment

    Time frame: After 1 hour of OKS

  5. Effect of OKS on gait

    Balance assessments

    Time frame: After 1 hour of OKS

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Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Mar 2023, 58 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2018
First posted
Mar 2, 2018
StartActual
May 1, 2018
Primary completionActual
Mar 31, 2023
CompletionActual
Mar 31, 2023
Last update
Jun 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03451708
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborators
Johns Hopkins University, National Eye Institute (NEI)
Responsible party
Chun Lim (Assistant Professor, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Mar 2, 2018
Start date
May 1, 2018
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Last update
Jun 5, 2024

Study contacts

Chun Lim, MD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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