OKS for the Treatment of Hemispatial Neglect

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03451708

Collaborator

Johns Hopkins University (Other), National Eye Institute (NEI) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in Hemispatial neglect scores [After 1 hour of OKS]
Performance on Center of Cancellation Test
Change in Hemispatial neglect scores [After 1 hour of OKS]
Performance on Behavioral Inattention Test
Effect of OKS on vision [After 1 hour of OKS]
visual acuity
Effect of OKS on vision [After 1 hour of OKS]
reading speed

Secondary Outcome Measures

Changes in secondary hemispatial neglect scores [After 1 hour of OKS]
Line bisection score
Changes in secondary hemispatial neglect scores [After 1 hour of OKS]
grip strength
Changes in secondary hemispatial neglect scores [After 1 hour of OKS]
extinction score
Effect of OKS on gait [After 1 hour of OKS]
Gait assessment
Effect of OKS on gait [After 1 hour of OKS]
Balance assessments

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

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:

Reduced vision
Documented vestibular disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center
Johns Hopkins University
National Eye Institute (NEI)

Investigators

Principal Investigator: Chun Lim, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chun Lim, Assistant Professor, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT03451708

Other Study ID Numbers:

2016P000396
R21EY027468

First Posted:

Mar 2, 2018

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Perceptual Disorders

Study Results

No Results Posted as of Mar 10, 2022