What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, including physical and cognitive exercise interventions, generally have minimal side effects. Physical exercise may cause muscle soreness and fatigue, while cognitive exercises like CBT can sometimes lead to temporary emotional discomfort. Pharmacologic treatments, such as cholinesterase inhibitors (e.g., rivastigmine and donepezil), can cause side effects like nausea, vomiting, and worsened tremor. These treatments aim to improve motor and non-motor symptoms, but side effects vary based on individual patient responses.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on dopaminergic medications such as Levodopa, which improves motor function and learning of tasks. Additionally, dopamine agonists have been used to manage symptoms like restless legs syndrome and improve depression. While physical and cognitive exercise interventions are not FDA-approved treatments, they are being studied for their potential benefits in improving muscle strength, flexibility, and pain management in Parkinson's Disease patients.

What other types of research exist?

Promising, novel alternatives to home-based physical and cognitive exercise interventions for Parkinson's Disease patients in 2024 include aquatic exercises, resistance training, mind-body exercises such as Tai Chi and yoga, telemedicine, and virtual reality (VR) interventions. These approaches can enhance muscle strength, flexibility, pain perception, and coping strategies.

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Cognitive Intervention

Telemedicine Intervention for Chronic Pain in Parkinson's Disease

N/A

Recruiting

Led By David William Sparrow, DSc

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Physician diagnosis of idiopathic PD

At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)

Must not have

History of ventricular dysrhythmia requiring current therapy

Angina pectoris

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests home-based physical and mental exercises to reduce pain in Veterans with Parkinson's disease. The exercises aim to make the body stronger and the mind more focused, helping to lessen the feeling of pain.

Who is the study for?

This trial is for individuals with Parkinson's Disease who experience chronic pain. Participants must have a physician's diagnosis of idiopathic PD, show at least two key symptoms (resting tremor, rigidity, or slow movement), and respond to medication that increases dopamine. It excludes those with recent heart issues like angina or myocardial infarction within the last six months.

What is being tested?

The study tests home-based physical and cognitive exercises along with health education as interventions to reduce pain in Parkinson's patients using telemedicine. This could help veterans maintain these practices indefinitely through remote access technology.

What are the potential side effects?

While specific side effects are not detailed here, typical risks may include muscle soreness from physical exercise and mental fatigue from cognitive tasks; however, these activities are generally considered safe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease by a doctor.

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I show at least 2 key symptoms of Parkinson's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently being treated for irregular heartbeats.

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I have chest pain due to heart problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Physical exercise interventionExperimental Treatment1 Intervention

Participants will receive the physical exercise intervention for 3 months.

Group II: Combined physical and cognitive exercise interventionExperimental Treatment2 Interventions

Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.

Group III: Cognitive exercise interventionExperimental Treatment1 Intervention

Participants will receive the cognitive exercise intervention for 3 months.

Group IV: Control groupActive Control1 Intervention

Participants will receive health education for 3 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical exercise intervention

2021

N/A

~600

0 / 4Eligibility criteria met

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

Common treatments for Parkinson's Disease (PD) include pharmacologic therapies like levodopa, dopamine agonists, and MAO-B inhibitors, which work by replenishing or mimicking dopamine to alleviate motor symptoms. Non-pharmacologic treatments, such as home-based physical and cognitive exercise interventions, aim to improve muscle strength, flexibility, and cognitive function. These interventions are particularly important for PD patients as they can enhance pain perception and coping strategies, thereby managing chronic pain and improving overall quality of life.