Acquired Brain InjuryNCT02753244
Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury
A study testing Motion Based Cognitive Video Games Software and iPad Apps in people with Acquired Brain Injury, run by Intendu Ltd. at 2 sites in Israel.
Trial summary
This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Motion Based Cognitive Video Games Software and iPad Apps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- Apr 2015to Jun 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Acquired Brain Injury.
- At least one functional upper limb.
- Ability to understand instructions that will be assessed by the therapist.
- Basic cognitive ability in Orientation, Visual Perception and Spatial Perception.
- Impairment in Executive Functions (EF) as assessed by EF assessments.
- normal vision.
Who cannot join
- Untreated epilepsy
- Other Psychiatric or Neurological disease.
- Neglect or Hemianopia.
- For the Community arm - doesn't receive any cognitive therapy.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Traumatic Brain Injury department, Loewenstein Hospital
Raanana, 43100
Yaron Sacher, MD, +972-9-7709920, ysacher@clalit.org.il
Rotem Eliav, BOT, rotemeliav1@gmail.com
- Not yet recruiting
The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
Ramat Gan, 5262100
Ofer Keren, MD, +972-3-5305158, Ofer.Keren@sheba.health.gov.il
Elena Tchvaloon, MD, +972-3-5305158, Elena.Tchvaloon@sheba.health.gov.il
About this study
Official title: A Study to Assess the Feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury Patients and to Evaluate the Effects of Training on Their Cognitive Performance
This study aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance
Read the detailed description
This study includes three experimental arms to research cognitive video games involving motion interaction in ABI population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve a randomized controlled study with inpatient participants, where participants are randomly assigned to an intervention or control group. Recruitment phase includes cognitive assessments to evaluate eligibility for the study. In the assessment and post assessment phases cognitive performance is established.
Intervention includes 10 computerized training sessions of 30-45 minutes over 3 weeks period using Intendu Functional Brain Trainer (FBT). The control group intervention involves playing commercial iPad games for the same duration. Interventions will be performed in addition to standard inpatient treatment.
In addition to the randomized control study, a third experimental arm will be performed, were participants living in the community will perform a similar protocol with cognitive motion-based video games. The recruitment, assessment, post assessment and intervention phases will be similar to the above.
- Conditions
- Acquired Brain Injury
- Being tested
- Motion Based Cognitive Video Games Software, iPad Apps
- Keywords
- Cognitive VideoGames
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion Based Cognitive Video Games SoftwareOther
Intendu FBT motion based cognitive video games software
iPad AppsOther
Commercially available iPad game applications
| Study group | Role | What they receive |
|---|---|---|
| Intendu FBT inpatient | Experimental | Other: Motion Based Cognitive Video Games Software Receives: Other: Motion Based Cognitive Video Games Software |
| iPad games | Active comparator | Other: iPad apps Receives: Other: iPad Apps |
| Intendu FBT community | Experimental | Other: Motion Based Cognitive Video Games Software Receives: Other: Motion Based Cognitive Video Games Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Functions
Assessments of cognitive skills as they express in task performance.
Measured: Week 0, week 4
Change in Cognitive Performance Questionnaires
Questionnaire assessing cognitive skills as they express in everyday function.
Measured: Week 0, week 4
Secondary outcomes (2)
Experience during intervention
Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.
Measured: week 4
Safety - Record of any adverse event
Any adverse event occurring during or following the intervention will be recorded.
Measured: Weeks 0-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intendu Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tel Aviv University, Sheba Medical Center, Loewenstein Hospital
- Responsible party
- Sponsor
- Investigators
- Ofer Keren, MD, Principal investigator, Sheba Medical CenterYaron Sacher, MD, Principal investigator, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753244
- Sponsor's protocol ID
- 00070-001
- Other IDs
- 2215 - 15 - SMC
- Status last verified
- Feb 2018
- First submitted
- 10 Apr 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury Patients and to Evaluate the Effects of Training on Their Cognitive Performance
- ClinicalTrials.gov ID
- NCT02753244
- Acronym / sponsor ID
- 00070-001
- Conditions
- Acquired Brain Injury
- Keywords
- Cognitive VideoGames
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Intendu Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tel Aviv University, Sheba Medical Center, Loewenstein Hospital
- Study start
- Apr 2015
- Primary completion
- Jun 2018 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- 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 aims to assess the feasibility of Intendu Cognitive Motion-Based Videogames in Acquired Brain Injury (ABI) patients in inpatient treatment and in the community and to evaluate the effects of training on patients' cognitive performance
Detailed description
This study includes three experimental arms to research cognitive video games involving motion interaction in ABI population. The study consists of 4 primary phases: recruitment, assessment, intervention and post-intervention assessment. Two arms involve a randomized controlled study with inpatient participants, where participants are randomly assigned to an intervention or control group. Recruitment phase includes cognitive assessments to evaluate eligibility for the study. In the assessment and post assessment phases cognitive performance is established.
Intervention includes 10 computerized training sessions of 30-45 minutes over 3 weeks period using Intendu Functional Brain Trainer (FBT). The control group intervention involves playing commercial iPad games for the same duration. Interventions will be performed in addition to standard inpatient treatment.
In addition to the randomized control study, a third experimental arm will be performed, were participants living in the community will perform a similar protocol with cognitive motion-based video games. The recruitment, assessment, post assessment and intervention phases will be similar to the above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intendu FBT inpatient | Experimental | Other: Motion Based Cognitive Video Games SoftwareOther: Motion Based Cognitive Video Games Software |
| iPad games | Active comparator | Other: iPad AppsOther: iPad apps |
| Intendu FBT community | Experimental | Other: Motion Based Cognitive Video Games SoftwareOther: Motion Based Cognitive Video Games Software |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with Acquired Brain Injury.
- At least one functional upper limb.
- Ability to understand instructions that will be assessed by the therapist.
- Basic cognitive ability in Orientation, Visual Perception and Spatial Perception.
- Impairment in Executive Functions (EF) as assessed by EF assessments.
Key exclusion criteria (4 listed)
- Untreated epilepsy
- Other Psychiatric or Neurological disease.
- Neglect or Hemianopia.
- For the Community arm - doesn't receive any cognitive therapy.
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 |
|---|---|---|
| Motion Based Cognitive Video Games SoftwareIntendu FBT motion based cognitive video games software | Other | Intendu FBT community, Intendu FBT inpatient |
| iPad AppsCommercially available iPad game applications | Other | iPad games |
Primary outcome
Change in Cognitive Functions
Time frame: Week 0, week 4
Assessments of cognitive skills as they express in task performance.
Change in Cognitive Performance Questionnaires
Time frame: Week 0, week 4
Questionnaire assessing cognitive skills as they express in everyday function.
2 secondary outcomes
Experience during intervention
Time frame: week 4
Safety - Record of any adverse event
Time frame: Weeks 0-4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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Fareon Open Label Device Clinical Trial
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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.
Ofer Keren, MD principal investigator
Sheba Medical Center
Yaron Sacher, MD principal investigator
Loewenstein Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion Based Cognitive Video Games Software and iPad Apps in people with Acquired Brain Injury, run by Intendu Ltd. at 2 sites in Israel.
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 6 inclusion and 4 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 Son Preminger, PhD (+972-9-7992240, son@intendu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Functions (time frame: Week 0, week 4). 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?
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 1 Mar 2018; AzTrials last refreshed its copy on 30 Oct 2026.