Telerehabilitation Alzheimer's Disease Feasibility (TADF)

NCT ID: NCT04732182

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2023-02-28

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.

Conditions

Alzheimer Disease; Healthy Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard of care medication for early Alzheimer's disease and BrightGo device cognitive training

Participants randomized to the experimental group will have standard of care and 8 weeks of experimental computer-based therapy on the device. Then they will cross over in the control arm. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch.

Group Type: EXPERIMENTAL

BrightGo cognitive training

Intervention Type: DEVICE

Training on the BrightGo experimental device in the home

Standard of Care medication for early Alzheimer's Disease

Intervention Type: DRUG

Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease

Standard of care medication for early Alzheimer's disease

Wait list controls will have standard of care only, before they cross over into the experimental group for BrightGo therapy. Total participation 4 months during which they will be on Aricept 10 mg daily or Exelon 9.5 mg patch.

Group Type: OTHER

Standard of Care medication for early Alzheimer's Disease

Intervention Type: DRUG

Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease

Interventions

BrightGo cognitive training

Training on the BrightGo experimental device in the home

Intervention Type: DEVICE

Standard of Care medication for early Alzheimer's Disease

Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease

Intervention Type: DRUG

Other Intervention Names

Gamification for cognitive therapy; Aricept 10 mg daily or Exelon 9.5 mg patch

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: collaborator

Bright Cloud International Corp

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grigore C. Burdea, PhD

Role: PRINCIPAL_INVESTIGATOR

Bright Cloud International

Locations

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Bright Cloud Int'l Corp

North Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Grigore C Burdea, PhD

Role: CONTACT

diplomatru@yahoo.com

9084069334

Edward A Berde, MS

Role: CONTACT

ed@brightcloud.health

7326400400

Facility Contacts

Jasdeep S Hundal, PsyD

Role: primary

jsh164@rwjms.rutgers.edu

732-235-6332

Daniel Valdivia, B.S.

Role: backup

djv85@gsbs.rutgers.edu

2013164424

Grigore C Burdea, PhD

Role: primary

diplomatru@yahoo.com

908-406-9334

Edward A Berde, MS

Role: backup

ed@brightcloud.health

732-640-0400

Other Identifiers

R43AG065035

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Telerehab AD Feasibility

Identifier Type: -

Identifier Source: org_study_id