Traumatic Brain InjuryCombiVirtualNCT03534128
Combinated Cues and Virtual Spatial Navigation
A study testing Evaluation of the effect of cues on virtual spatial navigation using a virtual district in people with Traumatic Brain Injury, run by Centre Ressources Francilien du Traumatisme Crânien at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Evaluation of the effect of cues on virtual spatial navigation using a virtual district
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Jun 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Absence of social assurance
- Ongoing legal protection
- Age under 18
- Pregnancy and breast-feeding
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
University Hospital of Bordeaux (Pellegrin)
Bordeaux, Aquitaine, 33000
Pierre-Alain Joseph, MD, PhD, 0033556795546, pierre-alain.joseph@chu-bordeaux.fr
Eric Sorita, PhD, 0033556795546, eric.sorita@chu-bordeaux.fr
- Recruiting
Rehabilitation Unit, Raymond Poincaré Hospital
Garches, Île-de-France Region, 92380
Mélanie Cogné, MD, PhD, 0033147107900, melanie.cogne@aphp.fr
Mélanie Cogné, MD, PhD
- Not yet recruiting
Rehabilitation Unit of Kerpape
Kerbach, Brittany Region, 56275
Jean-Luc Le Guiet, MD, 0033297826060, jlleguiet@kerpape.mutualite56.fr
Jean-Luc Le Guiet, MD
- Not yet recruiting
University Hospital of Rennes (Pontchaillou)
Rennes, Brittany Region, 35000
Isabelle Bonan, Md, PhD, isabelle.bonan@chu-rennes.fr
Isabelle Bonan, MD, PhD
About this study
Official title: Influence of Visual, Auditory and Combinated Cues on Virtual Spatial Navigation in Brain-injured Patients.
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.
Read the detailed description
- Main objective of the study: to determine if the combination between visual and auditory cues improve spatial navigation and memory of patients with a traumatic brain injury (TBI).
- Secondary objective of the study: to determine if the number of patients (%) with no trajectory mistakes with combined cues differs significantly from the one of healthy controls.
- Investigation centers: 4 : Rehabilitation Unit of Raymond Poincaré Hospital (Garches, France); Rehabilitation Unit of the University Hospital of Bordeaux (France); Rehabilitation Unit of the University Hospital of Rennes (France); Rehabilitation center of Kerpape (France)
- Study description: prospective, clinical, randomized, controlled
- Inclusion criteria: for the patients: history of moderate or severe traumatic brain injury with no other previous neurological history; 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
- Procedure: 1) Selection of patients by the investigators in each center. Verification of the inclusion and the exclusion criteria, and delivery of the information note.
- Visit 1: At least 24 hours later, investigators will gather the written consent of the participants. Then, participants will have to reproduce actively with a joystick three different paths including 6 intersections that they have previously seen on a computer screen representing a virtual district. 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 on beeping sounds indicating the direction at each intersection. Visual cues consist on salient landmarks (red and blinking) positioning at each intersection. The virtual district used looks like a North-American medium-sized town. Duration: 1h30 maximum.
- A second visit will be organized less than 15 days after the Visit 1. It will consist of a classical neuropsychological evaluation, assessing global cognitive efficiency (using the Mini Mental State Examination), memory (using the Gröber and Buschke test and the Rey Figure), executive functions (using the Frontal Assessment Battery and the Stroop test), attentional functions (using the Zazzo test), visuo-spatial functions (using the Rotation Mental test, the Santa Barbara Questionnaire and a mental imagery test developed by Maurer and Descloux) and neglect (using a barrage test and the Catherine Bergego scale). Duration: 2 hours maximum.
- Duration of the study: 18 months
- Number of participants included (using a calculation for the number of participants): 45 patients with a traumatic brain injury, and 20 healthy controls
- Statistics: comparisons between conditions will be done using ANOVA tests, then 2-by-2 using t-tests (if normality is established; if not, Kruskall-Wallis tests and Wilcoxon tests will be used). Correlations (Pearson or Spearman tests) will be done between spatial navigation performances and neuropsychological results at pencil-and-paper tasks.
- Ethics: The consent of an Ethics Committee has been requested (pending). A clinician Research Associate will monitor the results. A meeting with the investigators of the 4 centers will be planned every 6 months.
- The Source data verification will be done by the Clinician Research Associate for each participant.
- Reporting for adverse effects: the possible adverse effects are fatigue, headache, cyber-sickness (the same effect that can occur during the use of a computer) and exceptionally epileptic seizure (risk limited by the shortness of the exposure with the computer; 8 minutes per path on average). If a severe adverse effect occurs, like an epileptic seizure, it will be immediately reported to the sponsor, and a formulary will be send to a specific cell (named "Cellule Vigilance de la Fédération de Recherche Clinique"). The participation of the subject to the study will be immediately stopped.
- Plan for missing data: the presence of missing data or lost participants has been taken into account in the calculation for the number of participants. The data will be analyzed in "intention-to-treat".
- Conditions
- Traumatic Brain Injury
- Being tested
- Evaluation of the effect of cues on virtual spatial navigation using a virtual district
- Keywords
- Traumatic Brain Injury, Spatial navigation, Virtual Reality, Cues
- Medical subject headings
- Brain Injuries, Traumatic, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Spatial navigation evaluation | Experimental | Not described Receives: Other: Evaluation of the effect of cues on virtual spatial navigation using a virtual district |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of trajectory mistakes
Number of trajectory mistakes during the reproduction of the path (/6)
Measured: 1-8 minutes
Secondary outcomes (4)
Time of navigation
Time of navigation during the reproduction of the path (in seconds)
Measured: 1-8 minutes
Memory of landmarks
After navigation, spelling of the landmarks of the district and classification of these landmarks in a chronological order
Measured: 1-5 minutes
Memory of the route
After navigation, participants will have the recognize from a photography the direction that they have taken at each intersection
Measured: 1-5 minutes
Memory of survey
After navigation, participants will be asked to choose one drawing representing their path between 4 possibilities
Measured: 1-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start20 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Ressources Francilien du Traumatisme Crânien
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Responsible party
- Sponsor
- Investigators
- Mélanie Cogné, MD, PhD, Principal investigator, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534128
- Sponsor's protocol ID
- CombiVirtual
- Acronym
- CombiVirtual
- Status last verified
- Aug 2018
- First submitted
- 9 Apr 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Visual, Auditory and Combinated Cues on Virtual Spatial Navigation in Brain-injured Patients.
- ClinicalTrials.gov ID
- NCT03534128
- Acronym / sponsor ID
- CombiVirtual / CombiVirtual
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Spatial navigation, Virtual Reality, Cues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Ressources Francilien du Traumatisme CrânienUniversity, hospital or other
- Collaborators
- Fondation Paul Bennetot
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Main objective of the study: to determine if the combination between visual and auditory cues improve spatial navigation and memory of patients with a traumatic brain injury (TBI).
- Secondary objective of the study: to determine if the number of patients (%) with no trajectory mistakes with combined cues differs significantly from the one of healthy controls.
- Investigation centers: 4 : Rehabilitation Unit of Raymond Poincaré Hospital (Garches, France); Rehabilitation Unit of the University Hospital of Bordeaux (France); Rehabilitation Unit of the University Hospital of Rennes (France); Rehabilitation center of Kerpape (France)
- Study description: prospective, clinical, randomized, controlled
- Inclusion criteria: for the patients: history of moderate or severe traumatic brain injury with no other previous neurological history; 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
- Procedure: 1) Selection of patients by the investigators in each center. Verification of the inclusion and the exclusion criteria, and delivery of the information note.
- Visit 1: At least 24 hours later, investigators will gather the written consent of the participants. Then, participants will have to reproduce actively with a joystick three different paths including 6 intersections that they have previously seen on a computer screen representing a virtual district. 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 on beeping sounds indicating the direction at each intersection. Visual cues consist on salient landmarks (red and blinking) positioning at each intersection. The virtual district used looks like a North-American medium-sized town. Duration: 1h30 maximum.
- A second visit will be organized less than 15 days after the Visit 1. It will consist of a classical neuropsychological evaluation, assessing global cognitive efficiency (using the Mini Mental State Examination), memory (using the Gröber and Buschke test and the Rey Figure), executive functions (using the Frontal Assessment Battery and the Stroop test), attentional functions (using the Zazzo test), visuo-spatial functions (using the Rotation Mental test, the Santa Barbara Questionnaire and a mental imagery test developed by Maurer and Descloux) and neglect (using a barrage test and the Catherine Bergego scale). Duration: 2 hours maximum.
- Duration of the study: 18 months
- Number of participants included (using a calculation for the number of participants): 45 patients with a traumatic brain injury, and 20 healthy controls
- Statistics: comparisons between conditions will be done using ANOVA tests, then 2-by-2 using t-tests (if normality is established; if not, Kruskall-Wallis tests and Wilcoxon tests will be used). Correlations (Pearson or Spearman tests) will be done between spatial navigation performances and neuropsychological results at pencil-and-paper tasks.
- Ethics: The consent of an Ethics Committee has been requested (pending). A clinician Research Associate will monitor the results. A meeting with the investigators of the 4 centers will be planned every 6 months.
- The Source data verification will be done by the Clinician Research Associate for each participant.
- Reporting for adverse effects: the possible adverse effects are fatigue, headache, cyber-sickness (the same effect that can occur during the use of a computer) and exceptionally epileptic seizure (risk limited by the shortness of the exposure with the computer; 8 minutes per path on average). If a severe adverse effect occurs, like an epileptic seizure, it will be immediately reported to the sponsor, and a formulary will be send to a specific cell (named "Cellule Vigilance de la Fédération de Recherche Clinique"). The participation of the subject to the study will be immediately stopped.
- Plan for missing data: the presence of missing data or lost participants has been taken into account in the calculation for the number of participants. The data will be analyzed in "intention-to-treat".
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spatial navigation evaluation | Experimental | Other: Evaluation of the effect of cues on virtual spatial navigation using a virtual district |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of moderate or severe traumatic brain injury with no other previous neurological history 2/ For the healthy controls:
- No neurological history
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the effect of cues on virtual spatial navigation using a virtual districtEvaluation of the effect of cues on virtual spatial navigation using a virtual district | Other | Spatial navigation evaluation |
Primary outcome
Number of trajectory mistakes
Time frame: 1-8 minutes
Number of trajectory mistakes during the reproduction of the path (/6)
4 secondary outcomes
Time of navigation
Time frame: 1-8 minutes
Memory of landmarks
Time frame: 1-5 minutes
Memory of the route
Time frame: 1-5 minutes
Memory of survey
Time frame: 1-5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mélanie Cogné, MD, PhD principal investigator
Raymond Poincaré Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of the effect of cues on virtual spatial navigation using a virtual district in people with Traumatic Brain Injury, run by Centre Ressources Francilien du Traumatisme Crânien at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mélanie Cogné, MD, PhD (0033631924714, melanie.cogne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of trajectory mistakes (time frame: 1-8 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.