OKS for the Treatment of Hemispatial Neglect

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.

Study Overview

• Status: Completed
• Conditions: Neglect, Hemispatial; Neglect, Sensory; Neglect, Hemisensory
• Intervention / Treatment: Device: OKS

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun Lim, MD; Phone Number: 617-667-2926; Email: limlab888@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemispatial neglect scores	Performance on Center of Cancellation Test	After 1 hour of OKS
Change in Hemispatial neglect scores	Performance on Behavioral Inattention Test	After 1 hour of OKS
Effect of OKS on vision	visual acuity	After 1 hour of OKS
Effect of OKS on vision	reading speed	After 1 hour of OKS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in secondary hemispatial neglect scores	Line bisection score	After 1 hour of OKS
Changes in secondary hemispatial neglect scores	grip strength	After 1 hour of OKS
Changes in secondary hemispatial neglect scores	extinction score	After 1 hour of OKS
Effect of OKS on gait	Gait assessment	After 1 hour of OKS
Effect of OKS on gait	Balance assessments	After 1 hour of OKS

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Johns Hopkins University; National Eye Institute (NEI)
• Investigators: Principal Investigator: Chun Lim, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 24, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: 2016P000396; R21EY027468 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No