What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include dopaminergic medications like levodopa and dopamine agonists, which can cause side effects such as nausea, dizziness, somnolence, hallucinations, and orthostatic hypotension. Cholinesterase inhibitors, used for cognitive impairment, may lead to worsened tremor, nausea, and vomiting. Memantine, another cognitive treatment, can exacerbate neuropsychiatric symptoms like hallucinations and agitation. Non-pharmacologic interventions, such as self-administered rehabilitation games, are generally well-tolerated but require further study to confirm their efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including medications like levodopa, carbidopa, and dopamine agonists such as pramipexole and ropinirole. These drugs primarily aim to manage motor symptoms. Additionally, the FDA has permitted the marketing of digital therapeutics and medical devices for conditions like ADHD, which may be analogous to the cognitive and physical engagement therapies being studied for Parkinson's Disease. While specific FDA approvals for game-based cognitive and physical exercises in Parkinson's Disease are not detailed, the exploration of such therapies is ongoing and holds promise for improving cognitive function, depression, quality of life, and mobility in patients.

What other types of research exist?

Promising alternatives to self-administered rehabilitation games for Parkinson's Disease patients include virtual reality (VR) rehabilitation, immersive treadmill training, and telerehabilitation. These methods have demonstrated effectiveness in improving gait, postural control, and quality of life.

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Serious Games for Parkinson's Disease

N/A

Recruiting

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), post-intervention (week 12), follow-up (week 24)

Awards & highlights

Study Summary

This trial will explore whether self-administered rehabilitation games can help improve cognitive function, depression, quality of life, and mobility for patients with Parkinson's disease.

Who is the study for?

This trial is for English-speaking adults (18+) with mild to moderate Parkinson's Disease, as indicated by a Hoehn & Yahr stage of 1-3. Participants should have some comfort with technology and access to WiFi at home. Those with severe vision impairments or cognitive issues that would hinder task performance, or who do not wish to be recorded during sessions are excluded.Check my eligibility

What is being tested?

The study tests if 'serious games'—video games designed for rehabilitation—can improve cognitive function when used at home by people with Parkinson's Disease. It involves playing these games for two 30-minute sessions weekly over three months, alongside usual care, compared to a control group receiving only usual care.See study design

What are the potential side effects?

Since the intervention involves non-invasive video games designed for therapeutic purposes, no direct medical side effects are expected from participating in this trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), post-intervention (week 12), follow-up (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), post-intervention (week 12), follow-up (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), post-intervention (week 12), follow-up (week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Montreal Cognitive Assessment (MoCA)

Secondary outcome measures

Digit span forward and backward

Mental Depression

LifeSpace Assessment

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in their home setting in addition to their conventional care

Group II: ControlActive Control1 Intervention

Patients will undergo only their conventional care

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) include pharmacologic and nonpharmacologic approaches. Pharmacologic treatments aim to replenish or mimic dopamine, the neurotransmitter deficient in PD, through medications like levodopa, dopamine agonists, and MAO-B inhibitors. Nonpharmacologic treatments, such as exercise and cognitive engagement, are also essential. These methods, including self-administered rehabilitation games, improve motor function, balance, and cognitive abilities by promoting neuroplasticity and overall brain health. This holistic approach is crucial for PD patients as it can enhance quality of life and potentially slow disease progression.

Effectiveness of home-based rehabilitation using active video games on quality of life, cognitive and motor functions in people with Parkinson's disease: a systematic review.Movement disorders in people with Parkinson disease: a model for physical therapy.

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Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

430 Previous Clinical Trials

64,638 Total Patients Enrolled

Media Library

Serious games Clinical Trial Eligibility Overview. Trial Name: NCT05551338 — N/A

Parkinson's Disease Research Study Groups: Control, Intervention

Parkinson's Disease Clinical Trial 2023: Serious games Highlights & Side Effects. Trial Name: NCT05551338 — N/A

Serious games 2023 Treatment Timeline for Medical Study. Trial Name: NCT05551338 — N/A

~7 spots leftby May 2025

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