Alzheimer DiseaseTADUNCT04731311
Telerehabilitation Alzheimer's Disease Usability (TADU)
A study testing Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease in people with Alzheimer Disease and Healthy Aging, run by Bright Cloud International Corp at 1 site in United States.
Trial summary
Usability evaluation of BrightGo cognitive telerehabilitation system. An experimental system was developed to enhance standard of care (medication effect) for Early Alzheimer's Disease populations. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Healthy Aging
- What is being tested?
- Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Good or corrected hearing;
- Good or corrected vision;
- No motor or cognitive impairments;
- English speaker;
- Willing to travel to usability site (NJ Bioscience Center)
- Inclusion Criteria for individuals with early Alzheimer's Disease:
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- Age 65 to 85;
- Diagnosis of early Alzheimer's (Montreal Cognitive Assessment [MoCA] score of 19-25) [Nasreddine et al 2005].
- English speakers;
- Ability to actively move UE and to flex/extend fingers;
- Stable on Aricept 10 mg daily intake, or Exelon 9.5 mg patch medication
- Able to consent;
- Good or corrected hearing;
- Good or corrected vision;
- Good upper extremity motor function, close to full range of movement of arms and fingers;
- Willing to travel to usability site (NJ Bioscience Center)
Who cannot join
- Those younger than 65;
- Severe visual impairments or legally blind;
- Severe hearing loss or deafness;
- Uncontrolled hypertension (>190/100 mmHg);
- Severe cognitive delay (MoCA <19);
- non-English speakers;
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- Those unable to provide consent;
- Unable to move arms and fingers, or with severe arthritis;
- Severe propensity to simulation sickness;
Trial locations and contacts
1 site in 1 country.
United States1 site
Bright Cloud Int'l Corp
North Brunswick, New Jersey, 08902
About this study
Official title: Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Usability
Usability evaluation of BrightGo cognitive telerehabilitation system. An experimental system was developed to enhance standard of care (medication effect) for Early Alzheimer's Disease populations. This computerized system will be undergo a usability evaluation by healthy and by elderly participants who are in the early phase of Alzheimer's Disease. Sessions will and with participants filling subjective evaluation questionnaires as well as the USE standardized form. Results will be used to address any uncovered issues before a follow on Pilot RCT Feasibility study. Participants will receive $25 after each evaluation session.
Read the detailed description
Study will start with 2 elderly healthy volunteers (one male and one female) with preference to those with no computer game experience. The healthy volunteers will each perform usability sessions (2 times per week) in the first 2 weeks. They will be instructed to move the arms, grasp and extend fingers, so to mimic the assumed functionality during subsequent feasibility component.
The usability subjects will test the game controller movement, the caregiver tablet interface, and test all therapeutic games. Each of the games will be tested at all levels of difficulty, so to detect any previously unknown bugs. They will further test system wireless communication and real-time graphics response to controller input (minimal lag and lack of freezing, smooth avatar control). Finally, they will test the set motor and cognitive baseline procedures, meant to adapt games to participant. Specifically, this research team has developed a relaxing scene to be shown to participants while their biosensors are measured. This will help interpret any changes occurring subsequently, during therapeutic game interactions so to get an indication of engagement, or lack of, with the game tasks.
At the end of each session, volunteers will fill in the USE standardized usability questionnaire [Lund 2001]. This questionnaire will rate the usefulness, ease of use, ease of learning, and satisfaction with the BrightGo system. The USE form will solicit comments on games instructions, ergonomic issues with the new hand controllers, and degree of assistance needed. Sessions will be inter-spaced with days when the programmer, engineer and our Research Therapist will address issues uncovered in the previous session(s).
The usability evaluation process will be repeated in the subsequent 2 weeks with two participants in the early phase of Alzheimer's disease. Their performance will be compared with that of the elderly healthy volunteers, so to better gauge the usability of the BrightGo system for the targeted population. The Usability study will inform necessary BrightGo system improvements prior to feasibility study. Participants with early phase of Alzheimer's disease will not test the caregiver tablet. Usability participants will be paid $25/session.
- Conditions
- Alzheimer Disease, Healthy Aging
- Being tested
- Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Virtual Reality, BrightGo, Head Mounted Display, Aricept, Exelon
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's DiseaseDevice
4 participants with undergo 4 usability evaluations each, inter-spaced by days when researchers will address design changes. 2 participants will be elderly healthy and 2 will have the early Alzheimer's disease. Each session will last up to 1 hour, during which participants will interact with tasks in the form of games. Games will be gradated in level of difficulty, increasing from session to session. They will be played with one game controller or with two controllers while participants wear an all-in-one head mounted display. The degree of cognitive engagement during tasks will be measured with custom biosensors and used in adjusting level of difficulty. Each participant will fill subjective evaluation form and a USE form assessing ease of use, usefulness, and perceived technology issues. Scores will be analyzed and data published, in conjunction with game performance data.
| Study group | Role | What they receive |
|---|---|---|
| Usability Evaluation of the BrightGo system | Other | Participants with rate the device in each of 4 usability evaluation sessions. Receives: Device: Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
USE questionnaire to assess the usability of a computerized system
A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the BrightGo system [Lund, 2001] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max).
Participants will also be able to comment in free form on aspects they liked most and least about the device.
Measured: At each of 4 evaluation sessions over 1 month from enrollment
Secondary outcomes (1)
Subjective rating questionnaire of the device and therapy
Participants rate the usefulness, satisfaction issues, and ease of use of the BrightGo system and therapeutic games. Form consists of questions, each rated on a 5-point Likert scale (1 worst to 7 best).
Measured: At each of 4 evaluation sessions over 1 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start29 Jul 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will perform same protocol consisting of 4 evaluation sessions of the BrightGo device
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bright Cloud International Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rutgers, The State University of New Jersey
- Responsible party
- Sponsor
- Investigators
- Grigore C Burdea, PhD, Principal investigator, Bright Cloud International Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731311
- Sponsor's protocol ID
- Telerehab AD Usability
- Other IDs
- R43AG065035
- Acronym
- TADU
- Status last verified
- Apr 2022
- First submitted
- 23 Jan 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not disclose data on individual participants
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Usability
- ClinicalTrials.gov ID
- NCT04731311
- Acronym / sponsor ID
- TADU / Telerehab AD Usability
- Conditions
- Alzheimer Disease, Healthy Aging
- Keywords
- Alzheimer's Disease, Virtual Reality, BrightGo, Head Mounted Display, Aricept, Exelon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bright Cloud International CorpIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Rutgers, The State University of New Jersey
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Usability evaluation of BrightGo cognitive telerehabilitation system. An experimental system was developed to enhance standard of care (medication effect) for Early Alzheimer's Disease populations. This computerized system will be undergo a usability evaluation by healthy and by elderly participants who are in the early phase of Alzheimer's Disease. Sessions will and with participants filling subjective evaluation questionnaires as well as the USE standardized form. Results will be used to address any uncovered issues before a follow on Pilot RCT Feasibility study. Participants will receive $25 after each evaluation session.
Detailed description
Study will start with 2 elderly healthy volunteers (one male and one female) with preference to those with no computer game experience. The healthy volunteers will each perform usability sessions (2 times per week) in the first 2 weeks. They will be instructed to move the arms, grasp and extend fingers, so to mimic the assumed functionality during subsequent feasibility component.
The usability subjects will test the game controller movement, the caregiver tablet interface, and test all therapeutic games. Each of the games will be tested at all levels of difficulty, so to detect any previously unknown bugs. They will further test system wireless communication and real-time graphics response to controller input (minimal lag and lack of freezing, smooth avatar control). Finally, they will test the set motor and cognitive baseline procedures, meant to adapt games to participant. Specifically, this research team has developed a relaxing scene to be shown to participants while their biosensors are measured. This will help interpret any changes occurring subsequently, during therapeutic game interactions so to get an indication of engagement, or lack of, with the game tasks.
At the end of each session, volunteers will fill in the USE standardized usability questionnaire [Lund 2001]. This questionnaire will rate the usefulness, ease of use, ease of learning, and satisfaction with the BrightGo system. The USE form will solicit comments on games instructions, ergonomic issues with the new hand controllers, and degree of assistance needed. Sessions will be inter-spaced with days when the programmer, engineer and our Research Therapist will address issues uncovered in the previous session(s).
The usability evaluation process will be repeated in the subsequent 2 weeks with two participants in the early phase of Alzheimer's disease. Their performance will be compared with that of the elderly healthy volunteers, so to better gauge the usability of the BrightGo system for the targeted population. The Usability study will inform necessary BrightGo system improvements prior to feasibility study. Participants with early phase of Alzheimer's disease will not test the caregiver tablet. Usability participants will be paid $25/session.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will perform same protocol consisting of 4 evaluation sessions of the BrightGo device
| Arm | Type | Receives |
|---|---|---|
| Usability Evaluation of the BrightGo system | Other | Device: Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's DiseaseParticipants with rate the device in each of 4 usability evaluation sessions. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Good or corrected hearing;
- Good or corrected vision;
- No motor or cognitive impairments;
- English speaker;
- Willing to travel to usability site (NJ Bioscience Center)
Key exclusion criteria (9 listed)
- Those younger than 65;
- Severe visual impairments or legally blind;
- Severe hearing loss or deafness;
- Uncontrolled hypertension (>190/100 mmHg);
- Severe cognitive delay (MoCA <19);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease4 participants with undergo 4 usability evaluations each, inter-spaced by days when researchers will address design changes. 2 participants will be elderly healthy and 2 will have the early Alzheimer's disease. Each session will last up to 1 hour, during which participants will interact with tasks in the form of games. Games will be gradated in level of difficulty, increasing from session to session. They will be played with one game controller or with two controllers while participants wear an all-in-one head mounted display. The degree of cognitive engagement during tasks will be measured with custom biosensors and used in adjusting level of difficulty. Each participant will fill subjective evaluation form and a USE form assessing ease of use, usefulness, and perceived technology issues. Scores will be analyzed and data published, in conjunction with game performance data. | Device | Usability Evaluation of the BrightGo system |
Primary outcome
USE questionnaire to assess the usability of a computerized system
Time frame: At each of 4 evaluation sessions over 1 month from enrollment
A standardized questionnaire to assess the usefulness, satisfaction and ease of use of the BrightGo system [Lund, 2001] when evaluated by study participants. The form consists of 30 questions, each rated on a 7-point Likert scale (1 worst 7 best). The score range for this form is 30 (min) to 210 (max). Participants will also be able to comment in free form on aspects they liked most and least about the device.
1 secondary outcome
Subjective rating questionnaire of the device and therapy
Time frame: At each of 4 evaluation sessions over 1 month from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- BCI's corporate site showing therapeutic games used with the deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. We will not disclose data on individual participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grigore C Burdea, PhD principal investigator
Bright Cloud International Corp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease in people with Alzheimer Disease and Healthy Aging, run by Bright Cloud International Corp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USE questionnaire to assess the usability of a computerized system (time frame: At each of 4 evaluation sessions over 1 month from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.