Dysexecutive SyndromeS'TIM 1NCT05122923
Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders (S'TIM)
A study testing Serious Game S'TIM in people with Dysexecutive Syndrome and Serious Game, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysexecutive Syndrome, Serious Game
- What is being tested?
- Serious Game S'TIM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 3 Dec 2020to 3 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- French-speaking male or female patient at least 18 years old
- Patient suffering from recent disorders (less than 6 months) of executive functions
- Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
- Patient affiliated or beneficiary of a social security scheme
- Patient having signed the free and informed consent.
Who cannot join
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
- Pregnant or breastfeeding woman,
- Patient hospitalized without consent.
- Patient with unstable psychiatric disorders
- Patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.)
Show all 10Show fewer
- Patient with executive function disorders greater than 6 months
- Negligent hemi patient
- Patient not familiar with the French language
- Patient with major neuro-visual disorders.
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Clinique de Provence Bourbonne
Aubagne, 13400
Michèle Timsit, Dr, 06.15.31.10.22, m.timsit@ramsaygds.fr
About this study
Official title: Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders
This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.
- Conditions
- Dysexecutive Syndrome, Serious Game
- Being tested
- Serious Game S'TIM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious Game S'TIMDevice
Video Game S'tim : the patient is inside a bedroom and he has to find a friend outside. this game will study the orientation, the memory of the patient
| Study group | Role | What they receive |
|---|---|---|
| Patients with Serious Game | Experimental | Not described Receives: Device: Serious Game S'TIM |
| Patients without Serious Game | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of using the serious-game S'TIM in terms of cognition
TAP sub-test ERFC : overall cognitive functions BREF : presence or absence of a cognitive and / or behavioral dysexecutive syndrome
Measured: 6 weeks
The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A
Behaviour Rating Inventory of Executive Function, Adult
Measured: 6 weeks
The effect of using the serious-game S'TIM at 6 weeks in terms of behavior with BRIEF-A
Behaviour Rating Inventory of Executive Function, Adult
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start3 Dec 2020
- Primary completion3 Dec 2021 (estimated)
- Study completion3 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysexecutive SyndromeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122923
- Sponsor's protocol ID
- 2019-A00244-53
- Acronym
- S'TIM 1
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders
- ClinicalTrials.gov ID
- NCT05122923
- Acronym / sponsor ID
- S'TIM 1 / 2019-A00244-53
- Conditions
- Dysexecutive Syndrome, Serious Game
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 3 Dec 2021 (estimated)
- Study completion
- 3 Jun 2022 (estimated)
- First posted
- 17 Nov 2021 (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.
This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Serious Game | Experimental | Device: Serious Game S'TIM |
| Patients without Serious Game | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- French-speaking male or female patient at least 18 years old
- Patient suffering from recent disorders (less than 6 months) of executive functions
- Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
- Patient affiliated or beneficiary of a social security scheme
- Patient having signed the free and informed consent.
Key exclusion criteria (10 listed)
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
- Pregnant or breastfeeding woman,
- Patient hospitalized without consent.
- Patient with unstable psychiatric disorders
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 |
|---|---|---|
| Serious Game S'TIMVideo Game S'tim : the patient is inside a bedroom and he has to find a friend outside. this game will study the orientation, the memory of the patient | Device | Patients with Serious Game |
Primary outcome
The effect of using the serious-game S'TIM in terms of cognition
Time frame: 6 weeks
TAP sub-test ERFC : overall cognitive functions BREF : presence or absence of a cognitive and / or behavioral dysexecutive syndrome
The effect of using the serious-game S'TIM at 6 weeks in terms of metacognition with the BRIEF-A
Time frame: 6 weeks
Behaviour Rating Inventory of Executive Function, Adult
The effect of using the serious-game S'TIM at 6 weeks in terms of behavior with BRIEF-A
Time frame: 6 weeks
Behaviour Rating Inventory of Executive Function, Adult
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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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.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious Game S'TIM in people with Dysexecutive Syndrome and Serious Game, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 5 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 17 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of using the serious-game S'TIM in terms of cognition (time frame: 6 weeks). The study lists 3 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 17 Nov 2021.