iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Summary

The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).

Conditions

• Parkinson's Disease
• PD
• Mild Cognitive Impairment
• MCI

Interventions

DEVICE

iPACES (interactive Physical and Cognitive Exercise System)

iPACES involves a "pedal-to-play" neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations.

DEVICE

PACE (Physical and Cognitive Exercise)

PACE involves a "pedal-while-play" experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations.

Sponsors & Collaborators

• Pacific Brain Health Center

  collaborator UNKNOWN

• 1st Playable Productions

  collaborator OTHER

• Adirondack Neuropsychological Associates

  collaborator UNKNOWN

• Albany Medical College

  collaborator OTHER

• Center for Balance, Mobility & Wellness at Gordon College

  collaborator UNKNOWN

• iPACES LLC

  lead INDUSTRY

Principal Investigators

• Bob Gillen, PhD · iPACES LLC

• Cay Anderson-Hanley, PhD · iPACES LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2025-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations