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

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

Study Overview

• Status: Unknown
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Other: Motion Based Cognitive Video Games Software; Other: iPad Apps

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Raanana, Israel, 43100
    • Recruiting
    • Traumatic Brain Injury department, Loewenstein Hospital
    • Contact: Yaron Sacher, MD; Phone Number: +972-9-7709920; Email: ysacher@clalit.org.il
    • Contact: Rotem Eliav, BOT; Email: rotemeliav1@gmail.com
  • Ramat-Gan, Israel, 5262100
    • Not yet recruiting
    • The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
    • Contact: Ofer Keren, MD; Phone Number: +972-3-5305158; Email: Ofer.Keren@sheba.health.gov.il
    • Contact: Elena Tchvaloon, MD; Phone Number: +972-3-5305158; Email: Elena.Tchvaloon@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intendu FBT inpatient; Other: Motion Based Cognitive Video Games Software	Other: Motion Based Cognitive Video Games Software; Intendu FBT motion based cognitive video games software
Active Comparator: iPad games; Other: iPad apps	Other: iPad Apps; Commercially available iPad game applications
Experimental: Intendu FBT community; Other: Motion Based Cognitive Video Games Software	Other: Motion Based Cognitive Video Games Software; Intendu FBT motion based cognitive video games software

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Functions	Assessments of cognitive skills as they express in task performance.	Week 0, week 4
Change in Cognitive Performance Questionnaires	Questionnaire assessing cognitive skills as they express in everyday function.	Week 0, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience during intervention	Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.	week 4
Safety - Record of any adverse event	Any adverse event occurring during or following the intervention will be recorded.	Weeks 0-4

Collaborators and Investigators

• Sponsor: Intendu Ltd.
• Collaborators: Tel Aviv University; Sheba Medical Center; Loewenstein Hospital
• Investigators: Principal Investigator: Yaron Sacher, MD, Loewenstein Hospital; Principal Investigator: Ofer Keren, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: April 10, 2016
• First Submitted That Met QC Criteria: April 24, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cognitive VideoGames
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 00070-001; 2215 - 15 - SMC (Other Identifier: Sheba Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO