CClinicalTrials.gg
Sign In
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 Withdrawn at 1 site in United States.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Why this study was withdrawn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
01

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.

02

Conditions studied

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

Browse trials for

03

Who can participate

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

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
04

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.

05

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

06

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
07

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

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Perceptual Disorders→

Other studies from this sponsor

Beth Israel Deaconess Medical Center

Start the discussion