Mild Traumatic Brain Injury; ConcussionSiMPlyRehabNCT03215082
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
A study testing Vestibular-Visual Intervention in people with Mild Traumatic Brain Injury; Concussion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 3 countries.
Trial summary
The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury. Read more about this study
- Who is it for?
- Ages 6 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury; Concussion
- What is being tested?
- Vestibular-Visual Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Jan 2018to Dec 2020
- 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 6 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mild TBI or moderate-severe TBI will be included
Who cannot join
- -
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites, 2 recruiting
- Recruiting
Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary,
Calgary, Alberta, T2N 1N4
Kathryn Schneider, PhD, 403-210-8951, kjschnei@ucalgary.ca
- Recruiting
Montreal Children's Hospital, MUHC
Montreal, Quebec, H4A3J1
Isabelle Gagnon, PhD, 514-412-4400 ext. 23896, isabelle.gagnon8@mcgill.ca
France1 site, 1 recruiting
- Recruiting
Service de Rééducation des Pathologies Neurologiques de l'Enfant - Pôle de Rééducation et Réadaptation de l'Enfant Hôpitaux de Saint Maurice
Saint-Maurice, 94410
Mathilde Chevignard, PhD, 01 43 96 63 40, m.chevignard@hopitaux-stmaurice.fr
Israel1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine
Tel Aviv
Michal Katz-Leurer, PhD, 97236405432, michalkz@post.tau.ac.il
About this study
The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury.
This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.
- Conditions
- Mild Traumatic Brain Injury; Concussion
- Being tested
- Vestibular-Visual Intervention, standard care
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular-Visual InterventionOther
vestibular-visual exercises
standard careBehavioural
standard care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The intervention will be an individualized impairment-based program based on a pre-determined sequence. A minimal intervention for all participants randomized to the intervention group at all sites will include general oculomotor and gaze stabilization retraining as tolerated. Intervention activities will be recorded and described in detail in a treatment log. Receives: Other: Vestibular-Visual Intervention |
| Control | Active comparator | Standard care for mild TBI consists mainly of general education, energy conservation, academic adaptations, and restricting children and adolescents from participation in vigorous physical activities as well as complex cognitive activities until complete symptom resolution. It is the usual approach promoted by various associations and consensus groups. In addition, in all participating centers, children and teens requiring musculoskeletal approaches to address neck pain/dysfunction will receive it as indicated, based on the clinical judgment of the local team. Participants with moderate and severe TBI will also receive rehabilitation activities as planned in their respective centers. The standard care intervention will be recorded and described in detail in a treatment log. Receives: Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PedsQL
Pediatric and adult Quality of Life
Measured: 8 weeks post intervention initiation
Head Thrust Test
Vestibulo-Ocular Reflex
Measured: 8 weeks post-intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Jan 2018
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury; ConcussionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215082
- Sponsor's protocol ID
- 2018-3373
- Acronym
- SiMPlyRehab
- Status last verified
- Apr 2019
- First submitted
- 9 Jul 2017
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sorek G, Shaklai S, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Katz-Leurer M. Impact of Subarachnoid Hemorrhage on the Cardiac Autonomic Function During Rehabilitation in Children After Severe Traumatic Brain Injury. Neurotrauma Rep. 2023 Jul 14;4(1):458-462. doi: 10.1089/neur.2023.0032. eCollection 2023.
PubMed 37475976Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The Cardiac Autonomic Response Recovery to the Modified Tilt Test in Children Post Moderate-Severe Traumatic Brain Injury. Brain Inj. 2022 Jul 3;36(8):1033-1038. doi: 10.1080/02699052.2022.2110942. Epub 2022 Aug 15.
PubMed 35971307Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.
PubMed 32809873
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03215082
- Acronym / sponsor ID
- SiMPlyRehab / 2018-3373
- Conditions
- Mild Traumatic Brain Injury; Concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Jul 2017 (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.
The aim of this research program is to 1) Evaluate potential problems with vision, inner ear-eye reflexes and deficits of processing eye information that occur following TBI; and 2) Evaluate treatment programs for individuals with eye and inner ear problems that persist for greater than 10 days following injury.
This study will include 465 youth and young adults (aged 6-30 years old) who sustain a TBI of any severity. An initial evaluative phase using the best available technology to evaluate eye and inner ear function will be performed, and compared with typical tests that are used in the clinic. If symptoms and functional problems remain 10 days after injury, participants will be randomly placed into a treatment group (including eye movement, inner ear-eye reflex and attention exercises as per our pilot studies) or a control group (typical rehabilitation). Success will be measured in terms of return to sport (mild TBI), achievement of goals (moderate and severe TBI) and quality of life. It is expected that this program will inform clinical practice and future research leading to a treatment program in TBI that includes multiple components.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Vestibular-Visual InterventionThe intervention will be an individualized impairment-based program based on a pre-determined sequence. A minimal intervention for all participants randomized to the intervention group at all sites will include general oculomotor and gaze stabilization retraining as tolerated. Intervention activities will be recorded and described in detail in a treatment log. |
| Control | Active comparator | Behavioral: standard careStandard care for mild TBI consists mainly of general education, energy conservation, academic adaptations, and restricting children and adolescents from participation in vigorous physical activities as well as complex cognitive activities until complete symptom resolution. It is the usual approach promoted by various associations and consensus groups. In addition, in all participating centers, children and teens requiring musculoskeletal approaches to address neck pain/dysfunction will receive it as indicated, based on the clinical judgment of the local team. Participants with moderate and severe TBI will also receive rehabilitation activities as planned in their respective centers. The standard care intervention will be recorded and described in detail in a treatment log. |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mild TBI or moderate-severe TBI will be included
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Vestibular-Visual Interventionvestibular-visual exercises | Other | Experimental |
| standard carestandard care | Behavioural | Control |
Primary outcome
PedsQL
Time frame: 8 weeks post intervention initiation
Pediatric and adult Quality of Life
Head Thrust Test
Time frame: 8 weeks post-intervention initiation
Vestibulo-Ocular Reflex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Derived from this study: PubMed 37475976Sorek G, Shaklai S, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Katz-Leurer M. Impact of Subarachnoid Hemorrhage on the Cardiac Autonomic Function During Rehabilitation in Children After Severe Traumatic Brain Injury. Neurotrauma Rep. 2023 Jul 14;4(1):458-462. doi: 10.1089/neur.2023.0032. eCollection 2023.
- Derived from this study: PubMed 35971307Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The Cardiac Autonomic Response Recovery to the Modified Tilt Test in Children Post Moderate-Severe Traumatic Brain Injury. Brain Inj. 2022 Jul 3;36(8):1033-1038. doi: 10.1080/02699052.2022.2110942. Epub 2022 Aug 15.
- Derived from this study: PubMed 32809873Sorek G, Gagnon I, Schneider K, Chevignard M, Stern N, Fadida Y, Kalderon L, Shaklai S, Katz-Leurer M. The integrated functions of the cardiac autonomic and vestibular/oculomotor systems in adolescents following severe traumatic brain injury and typically developing controls. Brain Inj. 2020 Sep 18;34(11):1480-1488. doi: 10.1080/02699052.2020.1807055. Epub 2020 Aug 18.
- 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular-Visual Intervention in people with Mild Traumatic Brain Injury; Concussion, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 4 sites in 3 countries.
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 1 inclusion and 1 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 5 Apr 2019. 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 Canada, France, Israel. 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 Isabelle Gagnon, PhD (514-412-4400 ext. 23896, Isabelle.gagnon8@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PedsQL (time frame: 8 weeks post intervention initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215082, which also lists 3 linked publications.
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 5 Apr 2019.