Cognitive Training for Parkinson's Disease

Overseen By Sule Tinaz, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Dopaminergic medications

Disqualifiers: Non-English, Pregnancy, Alcohol, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cognitive training can enhance brain function and daily living skills in people with Parkinson's Disease. Participants will engage in either mental imagery exercises or psychoeducation (focused learning sessions). The study seeks individuals with Parkinson's Disease who are on a stable medication plan. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve the quality of life for those with Parkinson's Disease.

Will I have to stop taking my current medications?

The trial requires participants to stay on a stable dopaminergic medication regimen throughout the study, so you will not need to stop taking your current Parkinson's medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mental imagery training is generally well-tolerated by people with Parkinson's Disease (PD). Studies have found that this training can be used at any stage of PD recovery and effectively improves movement and motor skills. Individuals can perform it independently, making it safe and convenient.

For psychoeducation, evidence suggests it positively impacts thinking abilities and quality of life for people with PD. It is often part of cognitive behavioral therapy (CBT), a safe and effective way to manage non-motor symptoms of PD.

Both treatments in this trial have been studied in various settings and have shown promise with few safety concerns. However, safety can vary for each person, so consulting a healthcare provider is always best. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Cognitive Training for Parkinson's Disease trial because it explores innovative ways to manage symptoms beyond traditional medications like Levodopa or dopamine agonists. Mental Imagery Training, one of the focal points, encourages patients to visualize movements, potentially enhancing motor function without drugs. Meanwhile, Psychoeducation empowers patients with knowledge and coping strategies, aiming to improve quality of life and emotional well-being. These approaches are non-invasive and focus on mental and cognitive aspects, offering a promising complementary option to existing treatments.

What evidence suggests that this trial's treatments could be effective for Parkinson's Disease?

This trial will compare Mental Imagery Training and Psychoeducation for people with Parkinson's Disease (PD). Studies have shown that mental imagery training, which participants in this trial may receive, can be very helpful for people with PD. This method involves using imagination to practice tasks, and research shows it can improve brain function and assist with everyday activities. Another study suggested that mental imagery can boost the brain's ability to change and adapt, known as brain plasticity.

Psychoeducation, another treatment option in this trial, has research suggesting it can help lift mood and reduce anxiety in people with PD. Cognitive behavioral therapy, a component of psychoeducation, has proven effective in improving quality of life and mental sharpness. Both treatments show promise in managing PD symptoms and enhancing daily life. ^{2 3 4 6 7}

Who Is on the Research Team?

Sule Tinaz, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people over 40 with Parkinson's Disease who are on stable medication. Participants must speak English, not be pregnant or breastfeeding, have no excessive alcohol use, and no metal implants that affect MRI scans. They should be able to lie flat for an hour and not have severe cognitive impairments or other neurological disorders.

Inclusion Criteria

I am 40 years old or older.

I will be on a stable medication for dopamine regulation during the study.

I have been diagnosed with Parkinson's disease.

Exclusion Criteria

My Parkinson's disease is advanced; I can stand and walk but need help.

You have been diagnosed with dementia, and your Montreal Cognitive Assessment score is less than 21 out of 30.

I do not have severe tremors or uncontrollable movements that could affect imaging tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training to improve cognitive and brain functions

12 weeks

Regular sessions (frequency not specified)

Follow-up

Participants are monitored for changes in cognitive function and brain connectivity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mental Imagery Training
• Psychoeducation

Trial Overview The study tests if mental imagery training and psychoeducation can improve thinking skills and brain function in daily activities for those with Parkinson's. It involves cognitive assessments and MRIs to measure the effects of the interventions.

How Is the Trial Designed?

Group I: Mental Imagery Experimental Treatment 1 Intervention

Group II: Psychoeducation Active Control 1 Intervention

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9358873/

protocol for a systematic review and meta-analysis - PMC The study will review the evidence on the use of imagery in individuals with PD and to determine its efficacy in improving rehabilitation outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07193355

NCT07193355 | Effects of Motor Imagery Training MI can be applied at all stages of recovery from PD, is highly effective in movement-related pathologies, and can be performed independently.

3. medrxiv.org medrxiv.org/content/10.1101/2025.03.14.25324001v1.full-text

Effects of mental imagery training on cognitive function and ... In this study, we developed a cognitive training protocol based on mental imagery (MI) focusing on real-world tasks for people with PD.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03623386?tab=results

Effect of Mental Imagery Training on Brain Plasticity and ... Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease. ClinicalTrials.gov ID NCT03623386. Sponsor ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/15459683241246493

Effectiveness of Motor Imagery in the Rehabilitation ... It appears that an improvement in at least 1 domain of body structure and function may exert a positive effect on the quality of life of PwPD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10050121/

Mental imagery content is associated with disease severity ... Our findings suggest that mental imagery training combining VI and MI may enhance motor function in patients with mild PD.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8953975/

A Randomized Controlled Trial of Motor Imagery ... This study demonstrated that virtual reality and motor imagery training in combination with routine physical therapy can significantly improve resting tremors, ...