Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury

Acquired Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02753244
• Other study ID #: 00070-001
• Secondary ID: 2215 - 15 - SMC
• Status: Recruiting
• Phase: N/A
• First received: April 10, 2016
• Last updated: February 28, 2018
• Start date: April 2015

Study information

• Verified date: February 2018
• Source: Intendu Ltd.
• Contact: Son Preminger, PhD
• Phone: +972-9-7992240
• Email: son[@]intendu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• Motion Based Cognitive Video Games Software
Intendu FBT motion based cognitive video games software
• iPad Apps
Commercially available iPad game applications

Locations

Country	Name	City	State
Israel	Traumatic Brain Injury department, Loewenstein Hospital	Raanana
Israel	The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department	Ramat-Gan

Sponsors (4)

Lead Sponsor	Collaborator
Intendu Ltd.	Loewenstein Hospital, Sheba Medical Center, Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Functions	Assessments of cognitive skills as they express in task performance.	Week 0, week 4
Primary	Change in Cognitive Performance Questionnaires	Questionnaire assessing cognitive skills as they express in everyday function.	Week 0, week 4
Secondary	Experience during intervention	Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.	week 4
Secondary	Safety - Record of any adverse event	Any adverse event occurring during or following the intervention will be recorded.	Weeks 0-4