Traumatic Brain InjurySPORTiCARENCT05992194
Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)
An observational study of Traumatic Brain Injury, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head causes damage to the brain. The diagnosis of this pathology requires the evaluation of several dimensions, including clinical symptoms, physical signs, cognitive disorders, behavioral and sleep disturbances and state of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- multimodal oculomotor measurements
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2023to 2 Nov 2023
- Phase
- Observational
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group of 25 healthy volunteers
Who may be able to join
- Visual acuity of 10/10,
- Express consent to participate in the study,
- Affiliated (or beneficiary) of a social insurance scheme.
Who cannot join
- History of Cranioencephalic Trauma,
- Protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure (guardianship or curatorship).
- Subjects suffering from a degenerative disease or any other illness which could interfere with the evaluations planned during this study (migraine, balance disorders, vertigo).
- Subjects with ophthalmological pathologies affecting visual functions (oculomotor dysfunction, diplopia, strabismus).
- Known history of convergence and/or accommodation insufficiency.
- Subject declaring to the investigator in charge of anamnesis, consumption of psychoactive and psychotropic drugs, medications (anti-anxiety, antidepressant, anticonvulsant, opiate, analgesic, anti-hypertensive) or level 3 medications, which may have effects on vision.
- Unavailability of participant for evaluation sessions.
- Inability to comply with study task instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study Analyzing the Repeatability of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool
Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head causes damage to the brain. The diagnosis of this pathology requires the evaluation of several dimensions, including clinical symptoms, physical signs, cognitive disorders, behavioral and sleep disturbances and state of consciousness. This multidimensional approach provides a comprehensive and accurate assessment of head injury and its severity.
The Berlin Consensus of the International Conference on Concussion in Contact Risk Sports held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be multimodal and multidisciplinary.
Read more
This expert consensus converged on a tool that is now the most widely used in protocols studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion Assessment Tool), combines symptom assessment, cognitive examination, neurological examination (oculomotricity, balance) and immediate and delayed memory.
However, it requires the intervention of a medical expert to assess the clinical signs of the concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very good for the clinical symptomatology subscore, but poor or average for the subscores summarizing cognitive tests and balance assessment.
Clinicians now need to be able to better assess the severity of damage following head injury, and to monitor the patient's progress. This will improve the management of concussed athletes right up to their eventual return to sporting activity.
The ultimate aim of our project is to develop and optimize an easily exportable multimodal concussion assessment tool, based on the use of a virtual reality headset, which will enable us to objectively characterize the state and evolution of a subject after a TCE. This will enable the assessment of neuro-visual functions and compensations in the concussed patient, revealing a higher attentional cost characterized by instability of orthostatic control, higher blink frequency and larger pupil size.
The multimodal tool will be built from the results of various tests:
- Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided saccades, self paced saccades)
- Orthostatic balance control to assess postural compensations and estimate attentional cost during oculomotor tasks.
- Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study is to determine the repeatability of measurements provided by the SPORTiCARE virtual reality headset during different tasks.
- Conditions
- Traumatic Brain Injury
- Being tested
- multimodal oculomotor measurements
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multimodal oculomotor measurementsOther
- Visual assessment to ensure that the subject meets the inclusion and non-inclusion criteria, including anamnesis and the following visual tests: Lang stereotest, H-test ocular motility, convergence, masking and accommodative rock.
- Evaluation by experimenter A (60 min)
- Neuro-ophthalmological tests on screen
- Neuro-ophthalmological tests in VR headset
- Evaluation by experimenter B (60 min)
- Neuro-ophthalmological tests on screen
- Neuro-ophthalmological tests in VR helmet The sequence of experimenters A-B or B-A will be randomized.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of repeatability when performing pro-saccades
Latency (ms)
Measured: Day 0
Assessment of repeatability when performing anti-saccades
Latency (ms)
Measured: Day 0
Assessment of repeatability when performing memory tricks
Positional error (degrees)
Measured: Day 0
Assessment of repeatability of the number of saccades when performing self-paced saccades
number of saccades (n) performed between the two targets in the allotted time (15 seconds)
Measured: Day 0
Assessment of repeatability of pupil cycle time when performing self-paced saccades
Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
Measured: Day 0
Assessment of repeatability when performing pro-saccades
Latency (ms)
Measured: Between Day 7 and Day 21
Assessment of repeatability when performing anti-saccades
Latency (ms)
Measured: Between Day 7 and Day 21
Assessment of repeatability when performing memory tricks
Positional error (degrees)
Measured: Between Day 7 and Day 21
Assessment of repeatability of the number of saccades when performing self-paced saccades
number of saccades (n) performed between the two targets in the allotted time (15 seconds)
Measured: Between Day 7 and Day 21
Assessment of repeatability of pupil cycle time when performing self-paced saccades
Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
Measured: Between Day 7 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start23 Aug 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
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.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992194
- Sponsor's protocol ID
- SBN_2023_2
- Acronym
- SPORTiCARE
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2023
- Last updated
- 16 Feb 2024
- 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 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study Analyzing the Repeatability of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool
- ClinicalTrials.gov ID
- NCT05992194
- Acronym / sponsor ID
- SPORTiCARE / SBN_2023_2
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 15 Aug 2023 (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.
Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head causes damage to the brain. The diagnosis of this pathology requires the evaluation of several dimensions, including clinical symptoms, physical signs, cognitive disorders, behavioral and sleep disturbances and state of consciousness. This multidimensional approach provides a comprehensive and accurate assessment of head injury and its severity.
The Berlin Consensus of the International Conference on Concussion in Contact Risk Sports held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be multimodal and multidisciplinary.
This expert consensus converged on a tool that is now the most widely used in protocols studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion Assessment Tool), combines symptom assessment, cognitive examination, neurological examination (oculomotricity, balance) and immediate and delayed memory.
However, it requires the intervention of a medical expert to assess the clinical signs of the concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very good for the clinical symptomatology subscore, but poor or average for the subscores summarizing cognitive tests and balance assessment.
Clinicians now need to be able to better assess the severity of damage following head injury, and to monitor the patient's progress. This will improve the management of concussed athletes right up to their eventual return to sporting activity.
The ultimate aim of our project is to develop and optimize an easily exportable multimodal concussion assessment tool, based on the use of a virtual reality headset, which will enable us to objectively characterize the state and evolution of a subject after a TCE. This will enable the assessment of neuro-visual functions and compensations in the concussed patient, revealing a higher attentional cost characterized by instability of orthostatic control, higher blink frequency and larger pupil size.
The multimodal tool will be built from the results of various tests:
- Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided saccades, self paced saccades)
- Orthostatic balance control to assess postural compensations and estimate attentional cost during oculomotor tasks.
- Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study is to determine the repeatability of measurements provided by the SPORTiCARE virtual reality headset during different tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group of 25 healthy volunteers
Key inclusion criteria (3 listed)
- Visual acuity of 10/10,
- Express consent to participate in the study,
- Affiliated (or beneficiary) of a social insurance scheme.
Key exclusion criteria (8 listed)
- History of Cranioencephalic Trauma,
- Protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure (guardianship or curatorship).
- Subjects suffering from a degenerative disease or any other illness which could interfere with the evaluations planned during this study (migraine, balance disorders, vertigo).
- Subjects with ophthalmological pathologies affecting visual functions (oculomotor dysfunction, diplopia, strabismus).
- Known history of convergence and/or accommodation insufficiency.
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 |
|---|---|---|
| multimodal oculomotor measurements* Visual assessment to ensure that the subject meets the inclusion and non-inclusion criteria, including anamnesis and the following visual tests: Lang stereotest, H-test ocular motility, convergence, masking and accommodative rock. * Evaluation by experimenter A (60 min) * Neuro-ophthalmological tests on screen * Neuro-ophthalmological tests in VR headset * Evaluation by experimenter B (60 min) * Neuro-ophthalmological tests on screen * Neuro-ophthalmological tests in VR helmet The sequence of experimenters A-B or B-A will be randomized. | Other | – |
Primary outcome
Assessment of repeatability when performing pro-saccades
Time frame: Day 0
Latency (ms)
Assessment of repeatability when performing anti-saccades
Time frame: Day 0
Latency (ms)
Assessment of repeatability when performing memory tricks
Time frame: Day 0
Positional error (degrees)
Assessment of repeatability of the number of saccades when performing self-paced saccades
Time frame: Day 0
number of saccades (n) performed between the two targets in the allotted time (15 seconds)
Assessment of repeatability of pupil cycle time when performing self-paced saccades
Time frame: Day 0
Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
Assessment of repeatability when performing pro-saccades
Time frame: Between Day 7 and Day 21
Latency (ms)
Assessment of repeatability when performing anti-saccades
Time frame: Between Day 7 and Day 21
Latency (ms)
Assessment of repeatability when performing memory tricks
Time frame: Between Day 7 and Day 21
Positional error (degrees)
Assessment of repeatability of the number of saccades when performing self-paced saccades
Time frame: Between Day 7 and Day 21
number of saccades (n) performed between the two targets in the allotted time (15 seconds)
Assessment of repeatability of pupil cycle time when performing self-paced saccades
Time frame: Between Day 7 and Day 21
Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 8 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: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of repeatability when performing pro-saccades (time frame: Day 0). The study lists 10 primary outcomes in all. 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 16 Feb 2024.