- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955277
The Effectiveness of TECH: Tablet Enhancement of Cognition and Health (TECH)
The Effectiveness of TECH: Tablet Enhancement of Cognition and Health, Cognitive Training Using Touchscreen Tablet Gaming Applications, for Older Adults With Mild Cognitive Impairment
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Noa Givon, MSc OT
- Phone Number: +972543455303
- Email: noagivon@post.tau.ac.il
Study Locations
-
-
-
Tel Aviv, Israel
- Maccabi Healthcare Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 and above.
- Have MCI (as determined by the following four criterions: A. a score of 19-25 on the MoCA, B. subjective memory complaints, and report from an informant of the same memory complains (the informant should be a person who interacts with the participant three or more times a week), C. Informant report of the cognitive decline as newly acquired, D. independence in Basic Activities of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), as reported by the participants and the informant, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past.
- Have normal or corrected vision and hearing.
- Speak, write and read Hebrew.
- Able to understand and follow use of the touchscreen of a tablet after initial demonstration.
Exclusion Criteria:
- Experience severe depressive symptoms (10 points or more in The Geriatric Depression Scale)
- Are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, Parkinson's disease).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TECH protocol
TECH protocol - Daily self-training using tablet apps facilitated by weekly group sessions.
The self-training will take place independently at participants' home and will include mostly playing puzzle-apps to train different cognitive components.
Participants will be requested to play (and log) various apps three to five times a week for 30-60 minutes each time, for a total of 15-25 training sessions.
In addition they will use the tablets for a variety of everyday uses.
The individual self-training will be accompanied by six weekly sessions (of 60 minutes) in a small group setting (5-6 participants) led by an experienced occupational therapist.
|
Cognitive training using touchscreen tablets (TECH protocol)
|
Active Comparator: standard care or active standard care
Participants will receive standard occupational therapy with no TECH protocol.
or Will receive active standard care: six weekly group sessions (60 minutes) for cognitive training using puzzle games.
The setting will includes small groups of 5-6 participants, with no self training at home.
|
standard occupational therapy or 6-weekly group sessions playing board games and puzzles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Montreal Cognitive Assessment (MoCA)
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
A cognitive screening tool that assesses global cognition and includes the cognitive components: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Total score range from 0-30. A higher score indicates a better cognitive status. A score above 26 indicates normal cognition |
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WebNeuro
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
A computerized web-based battery assessment of neurocognitive functioning. The battery will include seven subtests that examine three cognitive domains: memory (Memory recognition/verbal list-learning task), executive planning (Switching of attention test, Verbal interference test, Maze test, Go-no-go test), and attention (Digit span test, Continuous performance test). A total thinking score will be calculated. Z score was calculated, providing a uniform comparison of the raw scores to a normative database, regardless of the original unit of measure used. The Z scores have a normative average of 0, with a standard deviation of 1, and no upper of lower limit. Positive values reflect better than average performance, and negative values reflect poorer than average performance. |
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
General Self-Efficacy Scale
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
Designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
It consists 10 statements such as 'I can solve most problems if I invest the necessary effort'.
Possible responses are scored 1-4 (1 - not at all true to 4 - exactly true), the total score range from 10 to 40.
Higher scores represent higher levels of general selfefficacy.
|
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
The 12-Item Short Form Health Survey (SF-12)
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
SF-12 includes 12 questions from the SF-36 Health Survey. The SF-36 is a widely used and investigated, and validated instrument for measuring quality of life. The SF-12 was developed using normative data for the SF-36 in the United States. The shorter version designed to reproduce the Physical and the Mental Components Summary scores. A greater score indicates better health measures. The Physical Composite and Mental Composite will be calculated. Scores range from 0 to 100 for each subscale, with higher scores indicating better physical and mental health functioning |
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Geriatric Depression Scale (GDS)
Time Frame: Pre intervention
|
Valid and reliable self-rating screening tool developed to detect depressive symptoms in elderly (D'ath, Katona, Mullan, Evans, & Katona, 1994; Lesher & Berryhill, 1994). The questionnaire includes 15 yes/no statements and takes up to10 minutes to complete. Total score ranges from 0-15. A higher score indicates a worse emotional state. Score above 10 points indicates the presence of depressive symptoms (Yesavage et al., 1983). |
Pre intervention
|
Structural and Functional Magnetic Resonance Imaging (MRI)
Time Frame: pre, post
|
Changes in brain volume, activity, and white-matter integrity will be assessed by MRI whole brain scanning. MRI scans will be performed on a 3T Prisma Siemens scanner at the Alfredo Federico Strauss Center for Computational Neuroimaging at Tel Aviv University. The MRI scans will include: two short structural assessments - magnetization prepared - rapid gradient echo (MP-RAGE) and fluid-attenuated inversion recovery (FLAIR) - diffusion tensor imaging (DTI) and functional magnetic resonance imaging (f-MRI) (while participants perform the N-back test). 12 Participants allocated to the TECH intervention (experimental group) will be offered to undergo pre and post MRI scans. |
pre, post
|
The Tower of Hanoi (ToH) Task - Nomber of Moves
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
A commonly used goal-directed measure assessing problem-solving, and specifically, planning.
A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task.
the number of moves per level were recorded.
less moves considered better.
|
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
The Tower of Hanoi (ToH) Task- Complition Time
Time Frame: pre intervention, post 5 weeks intervention, follow-up after 6 months
|
A commonly used goal-directed measure assessing problem-solving, and specifically, planning.
A computerized version of the task was used (http://vornlocher.de/tower).The participants completed the first two (out of six) levels of the task.
the time for completion (seconds) were recorded.
Shorter time for completetion considered better.
|
pre intervention, post 5 weeks intervention, follow-up after 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zvi Buckman, MD, Maccabi Healthcare Services, Israel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016009-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment
-
University of California, San FranciscoNational Institute on Aging (NIA)RecruitingMild Cognitive Impairment | Cognitive Decline | Cognitive Deterioration | Cognitive Impairment, Mild | Cognitive Deficits, MildUnited States
-
BaycrestCentre for Aging and Brain Health InnovationUnknownNeurocognitive Disorders | Cognitive Dysfunction | Mental Disorder | Cognitive Impairment, Mild | Cognitive Disorder | Nonamnestic Mild Cognitive ImpairmentCanada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Palo Alto Veterans Institute for ResearchU.S. Army Medical Research and Development CommandCompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
Xuanwu Hospital, BeijingWuhan University; Beijing Friendship Hospital; First Affiliated Hospital Xi'an... and other collaboratorsRecruitingAmnestic Mild Cognitive ImpairmentChina
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Jennifer BramenNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedAmnestic Mild Cognitive ImpairmentUnited States
-
Meir Medical CenterTerminatedMild Cognitive Impairment (MCI)Israel
Clinical Trials on TECH: Tablet Enhancement of Cognition and Health protocol
-
Assuta Hospital SystemsCompletedHealthy AdultsIsrael
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de...CompletedTobacco Use DisorderBrazil
-
National Institute on Alcohol Abuse and Alcoholism...Completed
-
University of California, Los AngelesNational Institute of Mental Health (NIMH)Active, not recruiting
-
Northeastern UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingAlcohol Drinking | Drinking Behavior | Alcohol UseUnited States
-
Shanghai Hengrui Pharmaceutical Co., Ltd.RecruitingPrevention of Venous Thrombosis After TKAChina
-
Universitätsklinikum Hamburg-EppendorfRecruitingSerratus Anterior Plane Block | Minimal Invasive Cardiac Surgery | Minimal Invasive Cardiac Surgery Mitral Valve SurgeryGermany
-
First Affiliated Hospital of Zhejiang UniversityHongguan biological pharmaceutical co.TerminatedParkinson's DiseaseChina
-
Zhejiang Cancer HospitalUnknownBreast Cancer | Breast Diseases | Neoplasm, BreastChina