Clinical trial NCT04732182: Telerehabilitation Alzheimer's Disease Feasibility (TADF)
Official title: Telerehabilitation Combining Virtual Reality Adaptable Games and Drug Therapy for Early Alzheimer's Disease - Feasibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
Healthy Aging
Keywords: Alzheimer's Disease
Virtual Reality
BrightGo
Caregiver
Elderly
Aricept
Exelon
Lead sponsor: Bright Cloud International Corp
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Aging (NIA)
name: Rutgers, The State University of New Jersey
First posted: 2021-02-01
Enrollment: 14
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot RCT. Participants are randomized equally into the experimental group and a wait-list control group. Randomization will be based on a randomization table prepared by a contracted bio-statistician.
Primary purpose: TREATMENT

Brief summary: This is a pilot RCT with equal arms: experimental arm and (wait list) control arm.

All participants will be in the early stage of Alzheimer's disease and on stable medication. They will all continue with this medication for their 6 months participation.

Experimental group will add weekly training on the experimental device, 5 days a week for 8 weeks. Training will involve therapeutic games aimed primarily at the memory cognitive domain. All participants will receive weekly calls from clinical coordinator and report on medication and overall health. Caregivers will also be enrolled so they support the trials.

Detailed description: Participants will be randomized equally into an experimental group and a wait list control group.

Experimental training will occur in the home, and will last 8 weeks, each week having 5 sessions of therapeutic game play. Each session will start with vitals being measured and logged followed by motor and biosensor baselines. Subsequently, participants will play an increasing number of games, targeted at the major cognitive domains of memory (primarily), attention and executive functions. Since sessions will increase in length, researchers expect that more than 10 short games may eventually be played in each session.

This will be an ABAA protocol for the experimental group, and a AABA protocol for the wait-list control group. Data will be sampled at baseline (A), during each rehabilitation session (B), mid-way through the study (at 2 months from baseline) and at the end of the study, at 4 months from baseline (A).

At the end of every 4 weeks of BrightGo training, the participant and caregiver will each fill a custom subjective evaluation questionnaire.

Before crossover to the experimental protocol, participants in the wait-list group will continue with their daily routine and prescribed medication (which will be logged). After crossing over, they will add the BrightGo intervention to their daily routine.

Participants initially randomized to the experimental group will continue with daily routine and medication, and add the 5 sessions per week of experimental therapy. Once they cross over to the control arm after 8 weeks from start, they will continue with their daily routine and prescribed medication (which will again be logged) for another 8 weeks.

All participants will receive a weekly call from the Clinical Coordinator so to report on any health concerns and system issues, as well as medication use. Caregivers will also be enrolled so they support the trials.

Eligibility criteria: Inclusion Criteria:

* 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;
* Living in the community in Central Jersey so to facilitate researchers travel to home for system installation and/or repairs,
* Living with a caregiver willing to support trials and be present during sessions;
* Good upper extremity motor function, close to full range of movement of arms and fingers.

Exclusion Criteria:

* Those younger than 65;
* Participating in other research studies;
* Severe visual impairments or legally blind;
* Severe hearing loss or deafness;
* Uncontrolled hypertension (\>190/100 mmHg);
* Severe cognitive delay (MoCA \<19);
* non-English speakers;
* Those unable to provide consent;
* Unable to move arms and fingers, or with severe arthritis;
* Severe propensity to simulation sickness;
* Those who are not cooperative with the evaluations pre-study ;
* Those who cannot produce reliable scores on the neuropsychological pre-study assessment because they do not comprehend the test, or have severe speech impairment;
* Those not living with a caregiver willing to support trials, and caregiver unwilling or unable to be present during sessions;
* Those that are unwilling allow home inspections to ascertain internet conditions in the home, to determine best placement for the experimental system, to install and remove system, and to provide repairs if needed.

Primary outcomes:
measure: Change in visual attention as measured by Neuropsychological Assessment Battery
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Controlled Oral Word Change in language and executive function as measured by the Association Test (CFL/PRW) of the Multilingual Aphasia Examination
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Change in Cognitive executive function assessment score
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Change in verbal memory as measured by Hopkins Verbal Learning Test, Revised (HVLT-R)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Change in visuospatial memory as measured by Brief Visuospatial MemoryTest, Revised (BVMT-R)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Change in Beck Depression Inventory II (BDI II) score, a measure of depression severity
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
Secondary outcomes:
measure: Change in the participant's quality of life as measured by the Quality of Life in Alzheimer's Disease Patient Version (QoL-AD)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Functional Activities Questionnaire in Older Adults with Dementia
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Test of Premorbid Functioning (TOPF)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Controlled Oral Word Association Test (CFL/PRW) of the Multilingual Aphasia Examination
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Categorical verbal fluency (Animal Naming)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Quality of Life in Alzheimers Disease (QoL-AD), Family Version
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Grasp strength (Jamar dynamometer)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Pinch strength (Jamar pinch meter)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Shoulder strength
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Arm range of motion (goniometer)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Jebsen test of hand function
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Chedokee test or independence in bimanual activities (CAHAI-9)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: University of Pennsylvania Smell Identification Test (UPSIT)
timeFrame: at baseline, at 8 weeks from baseline (2 months),and at 16 weeks from baseline (4 months)
measure: Subjective evaluation of BrightGo system and therapy
timeFrame: For experimental group test is at 4, and 8 weeks from baseline. For cross-over controlles test is at 12 and 16 weeks from baseline.
Other outcomes:
measure: Cybersickness Susceptibility Questionnaire
timeFrame: at enrollment (20 minutes)
measure: Montreal Cognitive Assessment (MoCA) to measure level of cognitive impairment
timeFrame: at enrollment (20 minutes)
measure: Pulse
timeFrame: Before and after each of experimental session. For 3 months post-baseline for experimental group, or starting at 3 months from baseline for controll group. After cross over control group will take pulse for 3 months.
measure: Blood pressure
timeFrame: Before and after each of experimental session. For 3 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
measure: Game score
timeFrame: During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
measure: Head Movement
timeFrame: During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
measure: Biosensor measure (eye blink)
timeFrame: During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
measure: Game difficulty
timeFrame: During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
measure: Biosensor measure (skin resistance)
timeFrame: During each experimental session. For 2 months post-baseline for experimental group. For control group it starts at 3 months from baseline for 3 more months.
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
city: North Brunswick
country: United States
facility: Bright Cloud Int'l Corp
state: New Jersey
Study officials:
affiliation: Bright Cloud International
name: Grigore C. Burdea, PhD
role: PRINCIPAL_INVESTIGATOR
References: