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Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02753244
Enrollment
50
Registered
2016-04-27
Start date
2015-04-30
Completion date
Unknown
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury

Keywords

Cognitive VideoGames

Brief 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

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.

Interventions

OTHERMotion Based Cognitive Video Games Software

Intendu FBT motion based cognitive video games software

OTHERiPad Apps

Commercially available iPad game applications

Sponsors

Tel Aviv University
CollaboratorOTHER
Sheba Medical Center
CollaboratorOTHER_GOV
Loewenstein Hospital
CollaboratorOTHER
Intendu Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with Acquired Brain Injury. 2. At least one functional upper limb. 3. Ability to understand instructions that will be assessed by the therapist. 4. Basic cognitive ability in Orientation, Visual Perception and Spatial Perception. 5. Impairment in Executive Functions (EF) as assessed by EF assessments. 6. normal vision.

Exclusion criteria

1. Untreated epilepsy 2. Other Psychiatric or Neurological disease. 3. Neglect or Hemianopia. 4. For the Community arm - doesn't receive any cognitive therapy.

Design outcomes

Primary

MeasureTime frameDescription
Change in Cognitive FunctionsWeek 0, week 4Assessments of cognitive skills as they express in task performance.
Change in Cognitive Performance QuestionnairesWeek 0, week 4Questionnaire assessing cognitive skills as they express in everyday function.

Secondary

MeasureTime frameDescription
Experience during interventionweek 4Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.
Safety - Record of any adverse eventWeeks 0-4Any adverse event occurring during or following the intervention will be recorded.

Countries

Israel

Contacts

Primary ContactSon Preminger, PhD
son@intendu.com+972-9-7992240
Backup ContactSivan Maoz, BOT
sivan@intendu.com+972-9-7992240

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026