Cognitive Training for Parkinson's Disease

(HOBSCOTCH-PD Trial)

Overseen By Sarah J Kaden, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Cognitive dysfunction, Visual impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) to determine if it can help people with Parkinson's Disease manage their symptoms more effectively. The researchers aim to discover if adapting this program, originally used for epilepsy, can improve quality of life and memory for Parkinson's patients. Participants will engage in virtual sessions with a coach and track their symptoms and progress. Individuals with Parkinson's who experience memory or thinking difficulties might be a good fit, especially if they have internet and phone access. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance daily living for Parkinson's patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this cognitive training program is safe for people with Parkinson's Disease?

Research shows that the HOBSCOTCH program aims to address thinking and memory problems through problem-solving techniques. While specific safety information for individuals with Parkinson's Disease is not available, the program has been used for epilepsy without major safety issues, suggesting potential safety. This pilot study serves as a small, initial test to evaluate the program's effectiveness for Parkinson’s Disease. Pilot studies typically assess practicality and safety. Participants will engage in online sessions, which are generally low-risk and convenient. Prospective participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HOBSCOTCH for Parkinson's Disease because it offers a unique approach to managing cognitive dysfunction through home-based self-management and cognitive training. Unlike standard treatments that primarily focus on medication like Levodopa or Dopamine agonists, HOBSCOTCH emphasizes empowering patients with skills to improve their daily cognitive function via personalized, virtual sessions. This method not only provides flexibility and accessibility for participants but also promotes active patient engagement in their own care, which could lead to improved quality of life.

What evidence suggests that the HOBSCOTCH program is effective for improving quality of life in people with Parkinson's Disease?

Studies have shown that the HOBSCOTCH program helps people with epilepsy improve their quality of life and mental abilities. This program emphasizes self-management and mental exercises, which have enabled individuals to manage their symptoms and enhance their focus. Participants with epilepsy who used HOBSCOTCH reported overall improvement, suggesting potential benefits for other conditions. In this trial, participants with Parkinson's Disease (PD) will receive the HOBSCOTCH-PD intervention. Although specific data for PD is still being collected, early signs are encouraging due to the program's success with similar conditions. The unique home-based design of HOBSCOTCH aims to be user-friendly and beneficial for those with PD. ^{1 2 5 6 7}

Who Is on the Research Team?

Elaine T Kiriakopoulos, MD, MPH, MSc

Principal Investigator

Dartmouth-Hitchcock, Dartmouth College

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who are experiencing cognitive impairment or memory loss. Participants will engage in a program called HOBSCOTCH-PD, which involves nine one-hour virtual sessions aimed at improving self-management and quality of life.

Inclusion Criteria

My doctor diagnosed me with Parkinson's Disease.

I experience problems with my memory or thinking.

I am between 30 and 75 years old.

Exclusion Criteria

Significant visual impairment precluding reading or writing

I am able to understand and give consent for my treatment.

No reliable telephone or internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HOBSCOTCH-PD Sessions

Participants attend nine, one-hour virtual sessions with a certified HOBSCOTCH-PD coach

9 weeks

9 virtual visits

Follow-up

Participants complete post-intervention questionnaires and a Satisfaction Survey

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH)

Trial Overview

The study tests whether the HOBSCOTCH program, originally designed for epilepsy patients, can be adapted to help those with Parkinson's Disease. It measures if participants see an improvement in their quality of life and cognitive functions after completing the program.

How Is the Trial Designed?

Group I: PD Participant with Cognitive Dysfunction Experimental Treatment 1 Intervention

Participants will receive the HOBSCOTCH-PD intervention consisting of 1:1 sessions delivered once per week including: * 1 pre-HOBSCOTCH Session (on webcam or by phone) * 1 educational session (on webcam) * 6 HOBSCOTCH intervention sessions (webcam or phone) * 1 wrap-up session (webcam or phone)

HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH) is already approved in United States for the following indications:

Approved in United States as HOBSCOTCH for:

• Epilepsy
• Under investigation for Multiple Sclerosis

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

Eighteen different self-management interventions for people with Parkinson's disease were identified, with 89% specifically tailored for this condition, but evidence supporting their effectiveness remains limited.

A moderate quality systematic review and a good quality randomized controlled trial suggest that self-management can improve certain aspects of quality of life for individuals with Parkinson's disease, highlighting the need for further research to pinpoint the most effective program components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management support programs for persons with Parkinson's disease: An integrative review. Kessler, D., Liddy, C.[2018]

A smartphone-based Parkinson's tracker app significantly improved medication adherence among patients with Parkinson's disease, with a mean difference of 0.39 compared to standard treatment after 16 weeks.

The app also enhanced patients' perception of the quality of their clinical consultations, indicating it can support better self-management in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a smartphone-based self-management platform to support medication adherence and clinical consultation in Parkinson's disease. Lakshminarayana, R., Wang, D., Burn, D., et al.[2022]

In a pilot study involving 3 individuals with Parkinson's disease, an 8-week program focused on using compensatory external aids led to significant improvements in achieving personalized goals related to cognitive deficits.

All participants not only improved their goal attainment immediately after the treatment but also maintained these gains one month later, highlighting the effectiveness of a patient-centered approach in cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Rehabilitation for Individuals With Parkinson's Disease: Developing and Piloting an External Aids Treatment Program. Spencer, KA., Paul, J., Brown, KA., et al.[2021]

The Operation House Call program successfully provided home-based care for seven underserved patients with Parkinson's disease, demonstrating that it is feasible to deliver effective medical care in a rural setting.

All patients remained functional and independent without hospitalization for PD-related complications, indicating the program's potential to improve quality of life and manage health effectively at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Person-Centered Care in the Home Setting for Parkinson's Disease: Operation House Call Quality of Care Pilot Study. Hack, N., Akbar, U., Monari, EH., et al.[2020]

Computerized cognitive training (CCT) has been shown to provide small but statistically significant improvements in overall cognitive function for people with Parkinson's disease, particularly benefiting those with mild cognitive impairment (PD-MCI).

The study analyzed 17 trials with 679 participants and found that greater doses of CCT were linked to larger cognitive benefits, indicating that CCT can be effective even when delivered remotely, but more extensive trials are needed to determine the best training regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in Parkinson's disease: A systematic review and meta-analysis. Gavelin, HM., Domellöf, ME., Leung, I., et al.[2022]

A systematic review of seven studies involving 225 participants found no clear evidence that cognitive training significantly improves global cognition in people with Parkinson's disease-related cognitive impairment, despite some positive trends in attention and verbal memory.

The review highlights the need for more robust studies with larger sample sizes and formal diagnostic criteria to better assess the efficacy of cognitive training interventions for individuals with Parkinson's disease dementia and mild cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training interventions for dementia and mild cognitive impairment in Parkinson's disease. Orgeta, V., McDonald, KR., Poliakoff, E., et al.[2022]

A novel client-centered cognitive strategy training intervention for people with Parkinson's disease (PD) was found to be feasible and well-accepted, with high participant satisfaction and engagement scores.

The intervention showed promising effects on self-identified cognitive problems, with significant improvements in functional ratings measured by the Canadian Occupational Performance Measure (COPM) after treatment sessions lasting an average of 9.2 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. Foster, ER., Spence, D., Toglia, J.[2019]

The study involved 76 participant-dyads with Parkinson's disease dementia (PDD) or dementia with Lewy bodies (DLB) and showed that the adapted Cognitive Stimulation Therapy (CST-PD) was feasible and well-accepted, with over 90% of dyads completing sessions longer than 20 minutes.

Participants reported high levels of interest and motivation, and there were no serious adverse events related to the intervention, suggesting that CST-PD is a safe and promising psychosocial approach for improving outcomes in PDD and DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's-adapted cognitive stimulation therapy: feasibility and acceptability in Lewy body spectrum disorders. McCormick, SA., Vatter, S., Carter, LA., et al.[2023]

A cognitive training program over 4 weeks significantly improved various cognitive functions, such as attention and memory, in 16 nondemented Parkinson's disease patients compared to a control group of 12 patients who received speech therapy.

Despite the cognitive improvements, there were no noticeable changes in self-reported quality of life or daily living activities, suggesting that while cognitive training can enhance mental performance, it may not directly translate to perceived quality of life benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blind randomized controlled study of the efficacy of cognitive training in Parkinson's disease. París, AP., Saleta, HG., de la Cruz Crespo Maraver, M., et al.[2022]

A pilot study involving eight people with Parkinson's disease explored their experiences using technology-based visuo-cognitive training (TVT) at home, revealing that user experience, ease of use, and support are crucial for successful implementation.

Participants valued the technology but faced challenges due to their fluctuating condition, highlighting the need for collaboration between patients and clinicians to ensure that the technology meets individual needs and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The integration of technology into a home-based visuo-cognitive training intervention for people with Parkinson's: Is the future digital? Das, J., Barry, G., Walker, R., et al.[2023]

This randomized controlled trial will assess the efficacy of online home-based cognitive training in 140 non-demented Parkinson's disease patients, focusing on improving cognitive functions over an eight-week period.

The study aims to evaluate not only the cognitive improvements but also the underlying neural mechanisms using neuroimaging, with follow-ups extending up to two years to monitor long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COGTIPS: a double-blind randomized active controlled trial protocol to study the effect of home-based, online cognitive training on cognition and brain networks in Parkinson's disease. van Balkom, TD., Berendse, HW., van der Werf, YD., et al.[2020]

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Study Details | NCT04519775 | HOBSCOTCH Phase III

The purpose of this study is to determine the efficacy of an entirely virtual version of the home-based cognitive self-management program "HOBSCOTCH.