Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury
Primary Purpose
Acquired Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Motion Based Cognitive Video Games Software
iPad Apps
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury focused on measuring Cognitive VideoGames
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Untreated epilepsy
- Other Psychiatric or Neurological disease.
- Neglect or Hemianopia.
- For the Community arm - doesn't receive any cognitive therapy.
Sites / Locations
- Traumatic Brain Injury department, Loewenstein HospitalRecruiting
- The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
Intendu FBT inpatient
iPad games
Intendu FBT community
Arm Description
Other: Motion Based Cognitive Video Games Software
Other: iPad apps
Other: Motion Based Cognitive Video Games Software
Outcomes
Primary Outcome Measures
Change in Cognitive Functions
Assessments of cognitive skills as they express in task performance.
Change in Cognitive Performance Questionnaires
Questionnaire assessing cognitive skills as they express in everyday function.
Secondary Outcome Measures
Experience during intervention
Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.
Safety - Record of any adverse event
Any adverse event occurring during or following the intervention will be recorded.
Full Information
NCT ID
NCT02753244
First Posted
April 10, 2016
Last Updated
February 28, 2018
Sponsor
Intendu Ltd.
Collaborators
Tel Aviv University, Sheba Medical Center, Loewenstein Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02753244
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intendu Ltd.
Collaborators
Tel Aviv University, Sheba Medical Center, Loewenstein Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury
Keywords
Cognitive VideoGames
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intendu FBT inpatient
Arm Type
Experimental
Arm Description
Other: Motion Based Cognitive Video Games Software
Arm Title
iPad games
Arm Type
Active Comparator
Arm Description
Other: iPad apps
Arm Title
Intendu FBT community
Arm Type
Experimental
Arm Description
Other: Motion Based Cognitive Video Games Software
Intervention Type
Other
Intervention Name(s)
Motion Based Cognitive Video Games Software
Intervention Description
Intendu FBT motion based cognitive video games software
Intervention Type
Other
Intervention Name(s)
iPad Apps
Intervention Description
Commercially available iPad game applications
Primary Outcome Measure Information:
Title
Change in Cognitive Functions
Description
Assessments of cognitive skills as they express in task performance.
Time Frame
Week 0, week 4
Title
Change in Cognitive Performance Questionnaires
Description
Questionnaire assessing cognitive skills as they express in everyday function.
Time Frame
Week 0, week 4
Secondary Outcome Measure Information:
Title
Experience during intervention
Description
Questionnaire regarding experience from intervention (e.g. satisfaction, exertion, etc.) following training.
Time Frame
week 4
Title
Safety - Record of any adverse event
Description
Any adverse event occurring during or following the intervention will be recorded.
Time Frame
Weeks 0-4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Untreated epilepsy
Other Psychiatric or Neurological disease.
Neglect or Hemianopia.
For the Community arm - doesn't receive any cognitive therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Son Preminger, PhD
Phone
+972-9-7992240
Email
son@intendu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sivan Maoz, BOT
Phone
+972-9-7992240
Email
sivan@intendu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Keren, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yaron Sacher, MD
Organizational Affiliation
Loewenstein Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Traumatic Brain Injury department, Loewenstein Hospital
City
Raanana
ZIP/Postal Code
43100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaron Sacher, MD
Phone
+972-9-7709920
Email
ysacher@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Rotem Eliav, BOT
Email
rotemeliav1@gmail.com
Facility Name
The Sheba Rehabilitation Hospital, The Head Trauma Rehabilitation Department
City
Ramat-Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ofer Keren, MD
Phone
+972-3-5305158
Email
Ofer.Keren@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Elena Tchvaloon, MD
Phone
+972-3-5305158
Email
Elena.Tchvaloon@sheba.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cognitive Motion-Based Videogames Exploratory Study in Acquired Brain Injury
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