iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Starting soon · Not applicable

Conditions studied: Parkinson's Disease, PD, Mild Cognitive Impairment, MCI

In brief

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.).

Key facts

Study ID

NCT05810454

Run by

iPACES LLC

People needed

120

Starts

2023-08-01

Expected to finish

2026-08-01

Last updated by the study team

2023-04-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 50 years of age or older
• meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)
• available for participation for one year (tablet surveys, videoconference evaluations) 5. willing and able to exercise 3-5 times per week for at least 6 months 6. can pedal an under-table elliptical 7. can read off of a small tablet screen 8. proficient in English (speaking and reading for completion of interview, surveys, game); Spanish language option anticipated soon 9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) 10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 11. can provide informed consent

You may not qualify if…

• already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
• significant history of cardiovascular problems
• significant history of stroke
• significant history of memory problems (e.g., dementia/Alzheimer's)
• significant history of other neurological condition (e.g., seizures, etc.)
• significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
• not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
• cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)

Where it is running

• remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail — Clifton Park, New York, United States

Full record on ClinicalTrials.gov

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