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OKS for the Treatment of Hemispatial Neglect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03451708
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : March 2, 2018
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Neglect, Hemispatial Neglect, Sensory Neglect, Hemisensory Device: OKS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Patient blinded
Primary Purpose: Treatment
Official Title: Optokinetic Stimulation for the Treatment of Hemispatial Neglect - Safety and Efficacy Studies
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Arm Intervention/treatment
Experimental: Optimization of OKS
Crossover study examining various OKS protocols on improving symptoms of hemispatial neglect
Device: OKS
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.

Experimental: Safety and efficacy study
Randomized study assessing the safety and efficacy of OKS in treating hemispatial neglect
Device: OKS
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.

Experimental: Effect of repetitive stimulation
Benefits of daily, repetitive OKS in treating hemispatial neglect
Device: OKS
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.

Experimental: OKS and gait
Effect of OKS on gait and balance
Device: OKS
Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.




Primary Outcome Measures :
  1. Change in Hemispatial neglect scores [ Time Frame: After 1 hour of OKS ]
    Performance on Center of Cancellation Test

  2. Change in Hemispatial neglect scores [ Time Frame: After 1 hour of OKS ]
    Performance on Behavioral Inattention Test

  3. Effect of OKS on vision [ Time Frame: After 1 hour of OKS ]
    visual acuity

  4. Effect of OKS on vision [ Time Frame: After 1 hour of OKS ]
    reading speed


Secondary Outcome Measures :
  1. Changes in secondary hemispatial neglect scores [ Time Frame: After 1 hour of OKS ]
    Line bisection score

  2. Changes in secondary hemispatial neglect scores [ Time Frame: After 1 hour of OKS ]
    grip strength

  3. Changes in secondary hemispatial neglect scores [ Time Frame: After 1 hour of OKS ]
    extinction score

  4. Effect of OKS on gait [ Time Frame: After 1 hour of OKS ]
    Gait assessment

  5. Effect of OKS on gait [ Time Frame: After 1 hour of OKS ]
    Balance assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Reduced vision
  • Documented vestibular disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451708


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Johns Hopkins University
Investigators
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Principal Investigator: Chun Lim, MD Beth Israel Deaconess Medical Center
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Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03451708    
Other Study ID Numbers: 2016P000396
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms