Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)

Traumatic Brain Injury Clinical Trial

— SPORTiCARE  

Official title:

Exploratory Study Analyzing the Repeatability of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05992194
• Other study ID #: SBN_2023_2
• Status: Completed
• Start date: August 23, 2023
• Est. completion date: November 2, 2023

Study information

• Verified date: February 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Visual acuity of 10/10,

• Express consent to participate in the study,

• Affiliated (or beneficiary) of a social insurance scheme.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Streetlab - Institut de la Vision	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of repeatability when performing pro-saccades	Latency (ms)	Day 0
Primary	Assessment of repeatability when performing anti-saccades	Latency (ms)	Day 0
Primary	Assessment of repeatability when performing memory tricks	Positional error (degrees)	Day 0
Primary	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)	Day 0
Primary	Assessment of repeatability of pupil cycle time when performing self-paced saccades	Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)	Day 0
Primary	Assessment of repeatability when performing pro-saccades	Latency (ms)	Between Day 7 and Day 21
Primary	Assessment of repeatability when performing anti-saccades	Latency (ms)	Between Day 7 and Day 21
Primary	Assessment of repeatability when performing memory tricks	Positional error (degrees)	Between Day 7 and Day 21
Primary	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)	Between Day 7 and Day 21
Primary	Assessment of repeatability of pupil cycle time when performing self-paced saccades	Pupil Cycle Time (PCT): average frequency of pupillary oscillation (Hz)	Between Day 7 and Day 21