Home-Based Cognitive Training for Multiple Sclerosis

(HOBSCOTCH-MS Trial)

Overseen By Carrie L Kruck, M.Clin Psych

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Cognitive dysfunction, Visual impairment, Psychiatric illness, 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

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based program, initially designed for epilepsy, can help individuals with multiple sclerosis (MS) better manage their symptoms. The primary focus is on enhancing quality of life and cognitive functions, such as memory and thinking. Participants will engage with a coach through virtual sessions and monitor their symptoms and progress. This trial suits those diagnosed with MS who face memory or thinking challenges and have access to a phone and internet. As an unphased trial, it offers a unique opportunity to explore innovative symptom management strategies for MS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on cognitive training and self-management strategies, so it's likely you can continue your current treatments, but you should confirm with the trial organizers.

What prior data suggests that this cognitive training program is safe for people with MS?

Research has shown that the HOBSCOTCH program, already used to assist people with epilepsy, might also benefit those with multiple sclerosis (MS). This program offers a non-drug, home-based method to manage symptoms and enhance cognitive skills. It teaches coping strategies to improve quality of life, and since it doesn't involve medication, it is not expected to cause the side effects associated with drugs.

While specific safety information for people with MS using HOBSCOTCH is not available, the program's design suggests it should be well-tolerated. Participants in similar programs typically report better symptom management without major issues. Since this trial focuses on adapting an existing program, the primary goal is to ensure it meets the needs of people with MS, rather than concentrating on safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HOBSCOTCH-MS program because it offers a fresh approach to managing cognitive dysfunction in people with Multiple Sclerosis (MS). Unlike traditional treatments that primarily focus on medication to manage physical symptoms, HOBSCOTCH-MS emphasizes cognitive training and self-management skills that can be done from home, making it more accessible and convenient. This method is unique because it combines personalized one-on-one sessions with educational materials, all delivered through webcam or phone, empowering participants to actively engage in their cognitive health. By focusing on cognitive skills and self-management, this program has the potential to significantly improve quality of life for those with MS.

What evidence suggests that the HOBSCOTCH-MS program could be effective for improving quality of life in people with multiple sclerosis?

Research has shown that the HOBSCOTCH program benefits people with epilepsy by improving their quality of life and mental abilities. In studies with epilepsy patients, HOBSCOTCH enabled better symptom management and increased control over their health. This trial will evaluate the HOBSCOTCH-MS intervention for individuals with multiple sclerosis (MS) who experience cognitive dysfunction. By adapting this approach for MS, there is potential for similar improvements in daily life and mental challenges. Early signs suggest that the methods used in HOBSCOTCH could help people with MS manage their symptoms more effectively. ^{1 2 3 4 6}

Who Is on the Research Team?

Heather A Wishart, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Elaine T Kiriakopoulos, MD, MSc

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for people aged 20-65 with MS who feel they have memory or cognitive issues. They must be able to read and speak English, have completed at least a grade 12 level of education, and have access to a telephone and the internet.

Inclusion Criteria

I have been diagnosed with multiple sclerosis.

I am between 20 and 65 years old.

Self-reported cognitive/memory difficulties

Exclusion Criteria

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

Significant visual impairment precluding reading or writing

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

Treatment

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

9 weeks

9 visits (virtual)

Follow-up

Participants are monitored for changes in cognition and quality of life after the HOBSCOTCH-MS program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The HOBSCOTCH program for epilepsy self-management is being tested to see if it can help improve the quality of life for those with MS. Participants will attend nine virtual sessions with a coach and complete questionnaires about their condition before and after these sessions.

How Is the Trial Designed?

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

Participants will receive the HOBSCOTCH-MS 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)

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Published Research Related to This Trial

The Cognitive Occupation-Based programme for people with MS (COB-MS) is being evaluated for its feasibility and preliminary efficacy in improving cognitive rehabilitation for individuals with multiple sclerosis, with 120 participants involved in a remote trial due to COVID-19.

Participants in the COB-MS group will undergo an eight-session program over 9 weeks, with outcomes measured at multiple time points, aiming to enhance daily functioning and quality of life for those affected by cognitive difficulties related to MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial. Dwyer, CP., Alvarez-Iglesias, A., Joyce, R., et al.[2023]

A home-based cognitive training program significantly improved verbal learning and working memory in 42 relapsing-remitting MS patients over a 6-week period, despite no changes in neurological status or quality of life.

The improvement in long-delay verbal memory performance was independent of brain atrophy, suggesting that cognitive training can be effective even in patients with early brain changes associated with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in MS: effects and relation to brain atrophy. Hildebrandt, H., Lanz, M., Hahn, HK., et al.[2022]

Cognitive rehabilitation for multiple sclerosis (MS) aims to help patients manage cognitive impairments, but more high-quality randomized trials are needed to confirm its effectiveness.

The review highlights the importance of considering the setting (center-based vs home-based) and mode (individual vs group) of cognitive rehabilitation treatments, which have not been thoroughly analyzed in existing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus on neglected features of cognitive rehabilitation in MS: Setting and mode of the treatment. Podda, J., Tacchino, A., Pedullà, L., et al.[2022]

A systematic review of 15 studies involving individuals with multiple sclerosis (MS) found strong evidence that nontraditional interventions like vestibular rehabilitation, yoga, and self-management can significantly improve daily activity performance.

Home-based programs, including cognitive behavioral therapy and physical activity, also showed strong efficacy in enhancing the ability of individuals with MS to perform daily activities, highlighting the importance of innovative therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of nontraditional or home-based programing on ADL performance of individuals living with multiple sclerosis: A systematic review. Belveal, K., Gunkel-Lam, S., Hajare, A., et al.[2023]

A group-based, self-management cognitive intervention program for individuals with multiple sclerosis (MS) positively impacted participants' ability to manage cognitive symptoms, as reported by 41 enrolled individuals.

Key components of the program included enhancing knowledge of cognitive changes, problem-solving through challenges, and practicing strategies in a group setting, with participants suggesting the inclusion of caregivers in future iterations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process evaluation of a self-management cognitive program for persons with multiple sclerosis. Shevil, E., Finlayson, M.[2015]

A home-based cognitive rehabilitation program using the video game Dr Kawashima's Brain Training showed significant improvements in attention and processing speed in patients with multiple sclerosis, as evidenced by better scores on the Stroop Test and Symbol Digit Modalities Test after 8 weeks of intervention.

The program also positively impacted some quality of life aspects for patients, suggesting that engaging in cognitive training through video games can be a beneficial therapeutic approach for managing cognitive challenges in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-cost cognitive rehabilitation with a commercial video game improves sustained attention and executive functions in multiple sclerosis: a pilot study. De Giglio, L., De Luca, F., Prosperini, L., et al.[2022]

Home-based computer-assisted cognitive rehabilitation is feasible for people with multiple sclerosis, as most participants adhered to the recommended training schedule over the 8-week intervention.

Despite some negative perceptions about the program, participants reported improvements in recognizing cognitive limitations and enhancing their daily life, indicating that the training can be beneficial even with some challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Computer-Assisted Cognitive Training: Feasibility and Perceptions of People with Multiple Sclerosis. Stuifbergen, A., Becker, H., Morgan, S., et al.[2021]

This study will evaluate the efficacy of a tablet-based serious game therapy (SGT) for cognitive rehabilitation in 150 ambulatory patients with multiple sclerosis (PwMS) over 4 months, comparing it to conventional cognitive exercises.

The primary outcome measure will be the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), with expectations that the SGT will show superior improvements in cognitive processing speed and episodic memory compared to standard rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving cognition in people with multiple sclerosis: study protocol for a multiarm, randomised, blinded trial of multidomain cognitive rehabilitation using a video-serious game (E-SEP cognition). Lenne, B., Degraeve, B., Davroux, J., et al.[2023]

The multiple sclerosis disease therapy management (DTM) program significantly improved medication adherence (92% vs 86%) and persistence (220 days vs 177 days) compared to retail pharmacy patients, indicating its effectiveness in supporting patients' treatment regimens.

Patients in the DTM program experienced a reduction in MS relapses from 14.0% at the start to 9.3% after 6 months, suggesting that the program not only helps with medication adherence but also contributes to better disease management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient self-management of multiple sclerosis through a disease therapy management program. Stockl, KM., Shin, JS., Gong, S., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06145737?term=AREA%5BBasicSearch%5D(ms%20as)&rank=9

HOme-Based Self-management and COgnitive Training ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06145737

HOme-Based Self-management and COgnitive Training ... The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169940/

Effectiveness of a Self-Management Program to Improve ... We conducted a multisite, pragmatic replication trial at 4 New England epilepsy centers to determine the effectiveness of Home-Based Self-Management and ...

4. dartmouth-hitchcock.org dartmouth-hitchcock.org/hobscotch-institute/hobscotch-ms-program

HOme-Based Self-Management and COgnitive Training ... The HOBSCOTCH-MS program teaches people how MS and cognitive problems can be related, and how to find strategies and solutions to better manage the day-to-day ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06145737/home-based-self-management-and-cognitive-training-changes-lives-hobscotch-multiple-sclerosis-ms

HOme-Based Self-management and COgnitive Training ... The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management ...

6. withpower.com withpower.com/trial/phase-multiple-sclerosis-11-2023-ed4b9

Home-Based Cognitive Training for Multiple Sclerosis · Info ... What data supports the effectiveness of the treatment HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) for multiple sclerosis?