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Combinated Cues and Virtual Spatial Navigation (CombiVirtual)

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ClinicalTrials.gov Identifier: NCT03534128
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Fondation Paul Bennetot
Information provided by (Responsible Party):
Centre Ressources Francilien du Traumatisme Crânien

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Evaluation of the effect of cues on virtual spatial navigation using a virtual district Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Visual, Auditory and Combinated Cues on Virtual Spatial Navigation in Brain-injured Patients.
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spatial navigation evaluation 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




Primary Outcome Measures :
  1. Number of trajectory mistakes [ Time Frame: 1-8 minutes ]
    Number of trajectory mistakes during the reproduction of the path (/6)


Secondary Outcome Measures :
  1. Time of navigation [ Time Frame: 1-8 minutes ]
    Time of navigation during the reproduction of the path (in seconds)

  2. Memory of landmarks [ Time Frame: 1-5 minutes ]
    After navigation, spelling of the landmarks of the district and classification of these landmarks in a chronological order

  3. Memory of the route [ Time Frame: 1-5 minutes ]
    After navigation, participants will have the recognize from a photography the direction that they have taken at each intersection

  4. Memory of survey [ Time Frame: 1-5 minutes ]
    After navigation, participants will be asked to choose one drawing representing their path between 4 possibilities



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1/ 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

Exclusion Criteria:

  • Deafness (more than 40 decibels at one ear)
  • Low non-corrected visual acuity
  • Severe comprehension issues
  • Severe behavioral issues (DSM IV definition)
  • Epileptic seizures during the 6 months preceding the inclusion in the present study, except the 14 days after the TBI
  • A non-stabilized acute disease
  • Absence of social assurance
  • Ongoing legal protection
  • Age under 18
  • Pregnancy and breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534128


Contacts
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Contact: Mélanie Cogné, MD, PhD 0033631924714 melanie.cogne@aphp.fr
Contact: Philippe Azouvi, MD, PhD 0033147107900 philippe.azouvi@aphp.fr

Locations
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France
University Hospital of Bordeaux (Pellegrin) Recruiting
Bordeaux, Aquitaine, France, 33000
Contact: Pierre-Alain Joseph, MD, PhD    0033556795546    pierre-alain.joseph@chu-bordeaux.fr   
Contact: Eric Sorita, PhD    0033556795546    eric.sorita@chu-bordeaux.fr   
Principal Investigator: Pierre-Alain Joseph, MD, PhD         
Sub-Investigator: Eric Sorita, PhD         
Rehabilitation Unit of Kerpape Not yet recruiting
Kerbach, Bretagne, France, 56275
Contact: Jean-Luc Le Guiet, MD    0033297826060    jlleguiet@kerpape.mutualite56.fr   
Principal Investigator: Jean-Luc Le Guiet, MD         
Principal Investigator: Pauline Coignard, MD         
University Hospital of Rennes (Pontchaillou) Not yet recruiting
Rennes, Bretagne, France, 35000
Contact: Isabelle Bonan, Md, PhD       isabelle.bonan@chu-rennes.fr   
Principal Investigator: Isabelle Bonan, MD, PhD         
Sub-Investigator: Mélanie Cogné, MD, PhD         
Rehabilitation Unit, Raymond Poincaré Hospital Recruiting
Garches, Ile-De-France, France, 92380
Contact: Mélanie Cogné, MD, PhD    0033147107900    melanie.cogne@aphp.fr   
Principal Investigator: Mélanie Cogné, MD, PhD         
Sub-Investigator: Philippe Azouvi, MD, PhD         
Sponsors and Collaborators
Centre Ressources Francilien du Traumatisme Crânien
Fondation Paul Bennetot
Investigators
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Principal Investigator: Mélanie Cogné, MD, PhD Raymond Poincaré Hospital

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Responsible Party: Centre Ressources Francilien du Traumatisme Crânien
ClinicalTrials.gov Identifier: NCT03534128     History of Changes
Other Study ID Numbers: CombiVirtual
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Ressources Francilien du Traumatisme Crânien:
Traumatic Brain Injury
Spatial navigation
Virtual Reality
Cues

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries