NCT03451708

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 5, 2024

Status Verified

June 1, 2024

Enrollment Period

4.9 years

First QC Date

February 8, 2018

Last Update Submit

June 4, 2024

Conditions

Neglect, HemispatialNeglect, SensoryNeglect, Hemisensory

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • Changes in secondary hemispatial neglect scores

    After 1 hour of OKS

  • Changes in secondary hemispatial neglect scores

    After 1 hour of OKS

  • Changes in secondary hemispatial neglect scores

    After 1 hour of OKS

  • Effect of OKS on gait

    After 1 hour of OKS

  • Effect of OKS on gait

    After 1 hour of OKS

Study Arms (4)

Optimization of OKS

EXPERIMENTAL

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

Device: OKS

Safety and efficacy study

EXPERIMENTAL

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

Device: OKS

Effect of repetitive stimulation

EXPERIMENTAL

Benefits of daily, repetitive OKS in treating hemispatial neglect

Device: OKS

OKS and gait

EXPERIMENTAL

Effect of OKS on gait and balance

Device: OKS

Interventions

OKSDEVICE

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

Effect of repetitive stimulationOKS and gaitOptimization of OKSSafety and efficacy study

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Reduced vision
  • Documented vestibular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • 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.

    PMID: 34196963DERIVED

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chun Lim, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient blinded
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 2, 2018

Study Start

May 1, 2018

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

June 5, 2024

Record last verified: 2024-06

Locations

US(1)