NCT04793516

Brief Summary

Participants in this study will help test and develop a virtual reality (VR) system that is being designed to help people with spatial neglect after stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

5.4 years

First QC Date

March 4, 2021

Last Update Submit

June 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Behavioral Inattention Test

    A battery of visuospatial tests using paper and pencil to perform line crossing, star cancellation, letter cancellation, line bisection, figure copying, and drawing. The test is scored from 0 to 146, with higher values indicating better performance.

    At baseline, after intervention, and two weeks after intervention

Secondary Outcomes (2)

  • Simulator Sickness Questionnaire

    After intervention

  • Semi-structured interview

    Two weeks after intervention

Study Arms (1)

VR-based spatial retraining

EXPERIMENTAL

Game-like therapy activities will be taken place in a virtual environment, provided through an immersive head-mounted display.

Other: VR Therapy Game

Interventions

Participants will complete 15 sessions of VR-based therapy modules developed for use in helping people with spatial neglect. These 15 sessions will be completed over 4-5 weeks.

VR-based spatial retraining

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Read and speak English fluently
  • Have a history of one stroke event that injured one cerebral hemisphere
  • Presence of moderate to severe spatial neglect

You may not qualify if:

  • History of progressive neurological disorders
  • History of significant psychiatric disorders
  • History of vestibular disorders
  • Living outside a 50-mile radius of Kessler Foundation (located in West Orange, NJ)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Peii Chen, PhD

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist, PI

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 11, 2021

Study Start

March 25, 2019

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations