Clinical trial NCT02753244: Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Keywords: Cognitive VideoGames
Lead sponsor: Intendu Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Tel Aviv University
name: Sheba Medical Center
name: Loewenstein Hospital
First posted: 2016-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cognitive Functions
timeFrame: Week 0, week 4
measure: Change in Cognitive Performance Questionnaires
timeFrame: Week 0, week 4
Secondary outcomes:
measure: Experience during intervention
timeFrame: week 4
measure: Safety - Record of any adverse event
timeFrame: Weeks 0-4
Other outcomes:
Locations:
city: Raanana
country: Israel
facility: Traumatic Brain Injury department, Loewenstein Hospital
city: Ramat-Gan
country: Israel
facility: The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
Study officials:
affiliation: Sheba Medical Center
name: Ofer Keren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Loewenstein Hospital
name: Yaron Sacher, MD
role: PRINCIPAL_INVESTIGATOR
References: