Cognitive Training for Parkinson's Disease
(HOBSCOTCH-PD Trial)
Recruiting in Palo Alto (17 mi)
Overseen byElaine T Kiriakopoulos, MD, MPH, MSc
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dartmouth-Hitchcock Medical Center
Disqualifiers: Cognitive dysfunction, Visual impairment, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)
The main questions it aims to answer are:
1. Can the current HOBSCOTCH program be adapted for people with PD?
2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?
Participants will be asked to:
* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach
* complete a brief clinical questionnaire about their diagnosis of PD
* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes
* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program
* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program
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 data supports the effectiveness of the treatment HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) for Parkinson's Disease?
Research shows that cognitive training, including home-based programs, can help improve cognitive functions in Parkinson's disease. Studies have demonstrated positive outcomes with personalized goals and the use of technology in cognitive training, suggesting that similar approaches in HOBSCOTCH may be effective.
12345Is cognitive training for Parkinson's disease safe for humans?
The research articles reviewed do not provide specific safety data for the cognitive training program known as HOBSCOTCH or similar programs. However, cognitive training and self-management programs for Parkinson's disease generally focus on non-drug approaches, which are typically considered safe for humans.
12678How is the HOBSCOTCH treatment different from other treatments for Parkinson's disease?
HOBSCOTCH is unique because it is a home-based cognitive training program specifically designed to help people with Parkinson's disease manage cognitive symptoms, focusing on self-management and personalized goals, unlike traditional treatments that often focus on medication or supervised therapy.
1491011Eligibility Criteria
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 can read and speak English and have completed at least 12 years of education.
I experience problems with my memory or thinking.
+2 more
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
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: PD Participant with Cognitive DysfunctionExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth-HitchcockLebanon, NH
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Who Is Running the Clinical Trial?
Dartmouth-Hitchcock Medical CenterLead Sponsor
References
Cognitive Rehabilitation for Individuals With Parkinson's Disease: Developing and Piloting an External Aids Treatment Program. [2021]Purpose Cognitive deficits are common in Parkinson's disease (PD) and can have a detrimental effect on daily activities. To date, most cognitive treatments have had an impairment-based focus with primary outcome measures of formal neuropsychological test scores. Few, if any, studies have focused on functional improvement or patient-centered goals. Method Three individuals with idiopathic PD participated in an 8-week pilot treatment program to train for the use of compensatory external aids to achieve personalized goals. Goal attainment scaling was the primary outcome measure, which was independently judged by multiple raters at baseline, postintervention, and 1 month posttreatment and analyzed via T-score analysis. Descriptive measures, including self-report and spouse-report rating scales of cognitive functioning, were employed. Results All 3 participants improved in the majority of their laboratory and home goals posttreatment, as measured by goal attainment scaling, and maintained gains for the majority of goals 1 month posttreatment. Conclusions This is the 1st known study to implement an external aids treatment program with patient-centered goals for individuals with cognitive deficits from PD. Positive outcomes were likely influenced by 3 factors: (a) a theoretically motivated focus on external aids; (b) a well-documented, systematic approach to instruction; and (c) the personalization of goals. Supplemental Material https://doi.org/10.23641/asha.10093493.
Self-management support programs for persons with Parkinson's disease: An integrative review. [2018]To identify the characteristics of self-management programs for persons with Parkinson's disease and the evidence for their effectiveness.
The integration of technology into a home-based visuo-cognitive training intervention for people with Parkinson's: Is the future digital? [2023]Mobile applications and technology (e.g., stroboscopic glasses) are increasingly being used to deliver combined visual and cognitive (termed visuo-cognitive) training that replaces standard pen and paper-based interventions. These 'technological visuo-cognitive training' (TVT) interventions could help address the complex problems associated with visuo-cognitive dysfunction in people with long term neurological conditions such as Parkinson's disease. As data emerges to support the effectiveness of these technologies, patient perspectives offer an insight into how novel TVT is received by people living with long term neurological conditions.
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. [2020]Cognitive dysfunction is highly prevalent in Parkinson's disease (PD) and a large proportion of patients eventually develops PD-related dementia. Currently, no effective treatment is available. Cognitive training is effective in relieving cognitive dysfunctions in several -neurodegenerative- diseases, and earlier small-scale trials have shown positive results for PD. In this randomized controlled trial, we assess the efficacy of online home-based cognitive training, its long-term effects, as well as the underlying neural correlates in a large group of PD patients.
Feasibility of a cognitive strategy training intervention for people with Parkinson's disease. [2019]To investigate the feasibility of a novel client-centered cognitive strategy training intervention for people with Parkinson's disease (PD).
Parkinson's-adapted cognitive stimulation therapy: feasibility and acceptability in Lewy body spectrum disorders. [2023]Drug-based therapeutic approaches for Parkinson's disease dementia (PDD) and dementia with Lewy bodies (DLB) are moderately effective and not always tolerated. Tailoring psychosocial approaches in PDD and DLB may offer additional support and improve outcomes. We adapted home-based, care partner-delivered Cognitive Stimulation Therapy (CST) for individuals with PDD or DLB and their care partners (CST-PD).
Using a smartphone-based self-management platform to support medication adherence and clinical consultation in Parkinson's disease. [2022]The progressive nature of Parkinson's disease, its complex treatment regimens and the high rates of comorbid conditions make self-management and treatment adherence a challenge. Clinicians have limited face-to-face consultation time with Parkinson's disease patients, making it difficult to comprehensively address non-adherence. Here we share the results from a multi-centre (seven centres) randomised controlled trial conducted in England and Scotland to assess the impact of using a smartphone-based Parkinson's tracker app to promote patient self-management, enhance treatment adherence and quality of clinical consultation. Eligible Parkinson's disease patients were randomised using a 1:1 ratio according to a computer-generated random sequence, stratified by centre and using blocks of variable size, to intervention Parkinson's Tracker App or control (Treatment as Usual). Primary outcome was the self-reported score of adherence to treatment (Morisky medication adherence scale -8) at 16 weeks. Secondary outcomes were Quality of Life (Parkinson's disease questionnaire -39), quality of consultation for Parkinson's disease patients (Patient-centred questionnaire for Parkinson's disease), impact on non-motor symptoms (Non-motor symptoms questionnaire), depression and anxiety (Hospital anxiety and depression scale) and beliefs about medication (Beliefs about Medication Questionnaire) at 16 weeks. Primary and secondary endpoints were analysed using a generalised linear model with treatment as the fixed effect and baseline measurement as the covariate. 158 patients completed the study (Parkinson's tracker app = 68 and TAU = 90). At 16 weeks Parkinson's tracker app significantly improved adherence, compared to treatment as usual (mean difference: 0.39, 95%CI 0.04-0.74; p = 0.0304) with no confounding effects of gender, number of comorbidities and age. Among secondary outcomes, Parkinson's tracker app significantly improved patients' perception of quality of consultation (0.15, 95% CI 0.03 to 0.27; p = 0.0110). The change in non-motor symptoms was -0.82 (95% CI -1.75 to 0.10; p = 0.0822). 72% of participants in the Parkinson's tracker app group continued to use and engage with the application throughout the 16-week trial period. The Parkinson's tracker app can be an effective and novel way of enhancing self-reported medication adherence and quality of clinical consultation by supporting self-management in Parkinson's disease in patients owning smartphones. Further work is recommended to determine whether the benefits of the intervention are maintained beyond the 16 week study period.
Person-Centered Care in the Home Setting for Parkinson's Disease: Operation House Call Quality of Care Pilot Study. [2020]Objective. (1) To evaluate the feasibility of implementing and evaluating a home visit program for persons with Parkinson's disease (PD) in a rural setting. (2) To have movement disorders fellows coordinate and manage health care delivery. Background. The University of Florida, Center for Movement Disorders and Neurorestoration established Operation House Call to serve patients with PD who could not otherwise afford to travel to an expert center or to pay for medical care. PD is known to lead to significant disability, frequent hospitalization, early nursing home placement, and morbidity. Methods. This was designed as a quality improvement project. Movement disorders fellows travelled to the home(s) of underserved PD patients and coordinated their clinical care. The diagnosis of Parkinson's disease was confirmed using standardized criteria, and the Unified Parkinson's Disease Rating Scale was performed and best treatment practices were delivered. Results. All seven patients have been followed up longitudinally every 3 to 6 months in the home setting, and they remain functional and independent. None of the patients have been hospitalized for PD related complications. Each patient has a new updatable electronic medical record. All Operation House Call cases are presented during video rounds for the interdisciplinary PD team to make recommendations for care (neurology, neurosurgery, neuropsychology, psychiatry, physical therapy, occupational therapy, speech therapy, and social work). One Operation House Call patient has successfully received deep brain stimulation (DBS). Conclusion. This program is a pilot program that has demonstrated that it is possible to provide person-centered care in the home setting for PD patients. This program could provide a proof of concept for the construction of a larger visiting physician or nurse program.
Computerized cognitive training in Parkinson's disease: A systematic review and meta-analysis. [2022]Cognitive impairment is a central non-motor symptom of Parkinson's disease (PD), and there are no established treatments. Computerized cognitive training (CCT) is a safe and efficacious strategy but its efficacy in PD is unclear. We aimed to investigate the efficacy of CCT on cognitive, psychosocial and daily function, and assess potential effect moderators in people with PD without dementia. Randomized controlled trials of CCT were included in multivariate meta-analyses and meta-regressions. Seventeen studies (16 trials) encompassing 679 participants were included. The pooled effect of CCT relative to control was small and statistically significant for overall cognitive function (g=0.16; 95% CI 0.02-0.29). There was robust evidence for benefit on clinical measures of global cognition across 10 trials (g=0.33; 95% CI 0.19-0.48), especially in PD with mild cognitive impairment (PD-MCI), as well as on individual cognitive domains. Greater CCT dose and PD-MCI population were associated with larger effect sizes, but no statistically significant differences were found between subgroups. There was no significant difference in the efficacy of home-based compared to supervised training. Our findings suggest that CCT is associated with cognitive benefits in PD, including when delivered remotely. Larger, well-powered trials are warranted to examine what specific CCT regimens are most likely to promote cognitive and everyday functioning in the long-term.
Cognitive training interventions for dementia and mild cognitive impairment in Parkinson's disease. [2022]Approximately 60% to 80% of people with Parkinson's disease (PD) experience cognitive impairment that impacts on their quality of life. Cognitive decline is a core feature of the disease and can often present before the onset of motor symptoms. Cognitive training may be a useful non-pharmacological intervention that could help to maintain or improve cognition and quality of life for people with PD dementia (PDD) or PD-related mild cognitive impairment (PD-MCI).
Blind randomized controlled study of the efficacy of cognitive training in Parkinson's disease. [2022]The aim of this study was to analyze the efficacy of a cognitive training program on cognitive performance and quality of life in nondemented Parkinson's disease patients. Participants who met UK Brain Bank diagnosis criteria for Parkinson's disease, with I-III Hoehn & Yahr, aged 50-80, and nondemented (Mini-Mental State Examination ≥ 23) were recruited. Patient's cognitive performance and functional and quality-of-life measures were assessed with standardized neuropsychological tests and scales at baseline and after 4 weeks. Subjects were randomly and blindly allocated by age and premorbid intelligence (Vocabulary, Wechsler Adult Intelligence Scale-III) into 2 groups: an experimental group and a control group. The experimental group received 4 weeks of 3 weekly 45-minute sessions using multimedia software and paper-and-pencil cognitive exercises, and the control group received speech therapy. A total of 28 patients were analyzed. Compared with the control group participants (n = 12), the experimental group participants (n = 16) demonstrated improved performance in tests of attention, information processing speed, memory, visuospatial and visuoconstructive abilities, semantic verbal fluency, and executive functions. There were no observable benefits in self-reported quality of life or cognitive difficulties in activities of daily living. We concluded that intensive cognitive training may be a useful tool in the management of cognitive functions in Parkinson's disease. © 2011 Movement Disorder Society.