NCT03534128

Brief 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.

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
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

4 active sites

Status
unknown

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

April 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

April 9, 2018

Last Update Submit

August 27, 2018

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain InjurySpatial navigationVirtual RealityCues

Outcome Measures

Primary Outcomes (1)

  • Number of trajectory mistakes

    Number of trajectory mistakes during the reproduction of the path (/6)

    1-8 minutes

Secondary Outcomes (4)

  • Time of navigation

    1-8 minutes

  • Memory of landmarks

    1-5 minutes

  • Memory of the route

    1-5 minutes

  • Memory of survey

    1-5 minutes

Study Arms (1)

Spatial navigation evaluation

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

Interventions

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

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

Spatial navigation evaluation

Eligibility Criteria

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

You may qualify if:

  • / For the patients:
  • History of moderate or severe traumatic brain injury with no other previous neurological history 2/ For the healthy controls:
  • No neurological history

You may not qualify if:

  • Deafness (more than 40 decibels at one ear)
  • Low non-corrected visual acuity
  • Severe comprehension issues
  • Severe behavioral issues (DSM IV definition)
  • A non-stabilized acute disease
  • Absence of social assurance
  • Ongoing legal protection
  • Age under 18
  • Pregnancy and breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital of Bordeaux (Pellegrin)

Bordeaux, Aquitaine, 33000, France

RECRUITING

Rehabilitation Unit of Kerpape

Kerbach, Brittany Region, 56275, France

NOT YET RECRUITING

University Hospital of Rennes (Pontchaillou)

Rennes, Brittany Region, 35000, France

NOT YET RECRUITING

Rehabilitation Unit, Raymond Poincaré Hospital

Garches, Île-de-France Region, 92380, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries, TraumaticSpatial Navigation

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSpatial BehaviorBehavior

Study Officials

  • Mélanie Cogné, MD, PhD

    Raymond Poincaré Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie Cogné, MD, PhD

CONTACT

0033631924714melanie.cogne@aphp.fr

Philippe Azouvi, MD, PhD

CONTACT

0033147107900philippe.azouvi@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2018

First Posted

May 23, 2018

Study Start

June 20, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)