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Combinated Cues and Virtual Spatial Navigation

NCT03534128 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-08-28

No results posted yet for this study

Summary

Many patients suffer from a topographical disorientation after a traumatic brain injury. Virtual Reality settings allow us to develop navigational cues, in order to rehabilitate patients or to help them in daily life. Some visual and auditory cues have proved efficient in helping patients navigating in a virtual environment but when administered separately, they never enabled patients to obtain a similar navigation performance as healthy controls. Moreover, the effect of the combination between visual and auditory cues has never been studied before. The objective of the present study is to determine if the combination between visual and auditory cues improve spatial navigation and memory of patients with a traumatic brain injury.

Therefore, the investigators intend to include in this prospective randomized study 45 patients who have had a moderate or severe traumatic brain injury and 20 healthy controls. Participants will have to reproduce actively with a joystick three different paths including 6 intersections that they have previously seen on a computer screen. One path will be done without cues, one with visual or auditory cues, and one with combined cues (visual+auditory). The order of the paths will be randomized. Auditory cues consist of beeping sounds indicating the direction at each intersection. Visual cues consist of salient landmarks (red and blinking) positioning at each intersection.

The main judgment criterion will be the number of trajectory mistakes during the path reproduction (/6). The secondary judgment criteria will be : time of navigation, memory of the landmarks, the route and the survey of the virtual environment. The confirmation of the help given by the combined cues could further allow the patients to use them in rehabilitation or in real life using augmented reality.

Conditions

Interventions

OTHER

Evaluation of the effect of cues on virtual spatial navigation using a virtual district

Evaluation of the effect of cues on virtual spatial navigation using a virtual district

Sponsors & Collaborators

  • Fondation Paul Bennetot

    collaborator OTHER

  • Centre Ressources Francilien du Traumatisme Crânien

    lead OTHER

Principal Investigators

  • Mélanie Cogné, MD, PhD · Raymond Poincaré Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534128 on ClinicalTrials.gov