Overseen ByDavid Ziegler, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this proposed research is to collect pilot data to test the hypothesis that treatment with a novel form of closed-loop digital meditation (MediTrain) will lead to a greater magnitude of gains in cognitive abilities in patients with mild cognitive impairment (MCI), compared to OA without cognitive impairment, and will lead to improvements in quantitative measures of sleep.
How is the MediTrain treatment different from other treatments for mild cognitive impairment?
MediTrain is unique because it is a digital intervention specifically designed to address cognitive deficits in mild cognitive impairment (MCI) through interactive and engaging methods, unlike traditional treatments that may not focus on digital engagement. This approach leverages technology to provide cognitive training in a way that is accessible and potentially more engaging for patients.
4671112Is the digital intervention for mild cognitive impairment safe for humans?
The safety of a cognitive-enhancing Tai Ji Quan training intervention, delivered online for older adults with mild cognitive impairment, was examined and found to be acceptable, suggesting it is generally safe for humans.
258910What data supports the effectiveness of the treatment MediTrain for mild cognitive impairment?
Research on similar digital interventions, like TECH and computer-based cognitive training, shows potential benefits in improving memory and cognitive functions in older adults with mild cognitive impairment. These studies suggest that digital treatments can help maintain or enhance cognitive abilities over time.
1371112Will I have to stop taking my current medications?
You will need to stop taking anti-depressants and anti-anxiety medications to participate in this trial.
Eligibility Criteria
This trial is for older adults who are experiencing mild cognitive impairment. Participants should be interested in testing digital interventions aimed at improving cognition, wellbeing, stress levels, and sleep quality.Inclusion Criteria
I am between 60 and 85 years old.
My vision and hearing are normal, or corrected to be normal.
Exclusion Criteria
I have a history of seizures.
I have macular degeneration.
I have strabismus.
I have received radiation seeds or implants.
I am currently taking medication for anxiety.
I have glaucoma.
I have a lazy eye.
I use a medication patch.
I have had a joint replacement surgery.
Participant Groups
The study is examining the effectiveness of a digital meditation program called MediTrain. It also uses wrist-worn multi-sensor watches and sleep monitors to track improvements in participants' cognitive abilities and sleep patterns.
1Treatment groups
Experimental Treatment
Group I: MediTrainExperimental Treatment3 Interventions
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Interactive computer-training as a therapeutic tool in Alzheimer's disease. [2006]The current study sought to evaluate a novel kind of interactive computer-based cognitive training (ICT) in Alzheimer's disease (AD). AD patients (N = 9), age- and gender-matched patients with a major depressive episode (N = 9), and healthy control subjects (N = 10) were trained to use an ICT program that relates to activities of daily living (ADL). Digital photographs of a shopping route were implemented in a close-to-reality simulation on a computer touch-screen. The task was to find a predefined shopping route, to buy three items, and to answer correctly 10 multiple-choice questions addressing knowledge related to the virtual tasks. Training performance was rated using the number of mistakes (wrong way), time needed for the tasks, number of correct multiple-choice answers, and of repeat of instruction. Compared to normal controls and depressed patients, AD patients performed significantly worse with regard to all variables. Within a 4-week training period including 12 sessions, however, substantial training gains were observed, including a significant reduction of mistakes. Training effects were sustained until follow-up 3 weeks later. The performance of the depressed patients and the normal controls improved as well, with no difference between the two groups. Self-reported effects revealed that the training was well perceived. Thus, the task performance of AD patients improved substantially and subjects appeared to have liked this approach to ICT. New interactive media, therefore, may yield interesting opportunities for rehabilitation and (psycho)therapeutic interventions.
Clinical trials in mild cognitive impairment: lessons for the future. [2018]Mild cognitive impairment (MCI) is an operational definition for a cognitive decline in individuals with a greater risk of developing dementia. The amnestic subtype of MCI is of particular interest because these individuals most likely progress to Alzheimer's disease (AD). Currently hypothesised therapeutic approaches in MCI are mainly based on AD treatment strategies. Long term secondary prevention randomised clinical trials have been completed in amnestic MCI populations, encompassing agents with various mechanisms of action: acetylcholinesterase inhibitors (donepezil, rivastigmine, galantamine), antioxidants (vitamin E), anti-inflammatories (rofecoxib), and nootropics (piracetam). The design of clinical trials in MCI is influenced by study objectives and definition of primary end points: time to clinical diagnosis of dementia, and AD in particular, or symptom progression. As none of the drugs previously shown to have clinical efficacy in AD trials or benefit in everyday practice have met the primary objectives of the respective trials, design of future clinical trials in MCI should be further developed particularly as regards the selection of more homogeneous samples at entry, optimal treatment duration, and multidimensional and reliable outcomes.
Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. [2022]We performed a pilot randomized, controlled trial of intensive, computer-based cognitive training in 47 subjects with mild cognitive impairment. The intervention group performed exercises specifically designed to improve auditory processing speed and accuracy for 100 min/d, 5 d/wk for 6 weeks; the control group performed more passive computer activities (reading, listening, visuospatial game) for similar amounts of time. Subjects had a mean age of 74 years and 60% were men; 77% successfully completed training. On our primary outcome, Repeatable Battery for Assessment of Neuropsychological Status total scores improved 0.36 standard deviations (SD) in the intervention group (P=0.097) compared with 0.03 SD in the control group (P=0.88) for a nonsignificant difference between the groups of 0.33 SD (P=0.26). On 12 secondary outcome measures, most differences between the groups were not statistically significant. However, we observed a pattern in which effect sizes for verbal learning and memory measures tended to favor the intervention group whereas effect sizes for language and visuospatial function measures tended to favor the control group, which raises the possibility that these training programs may have domain-specific effects. We conclude that intensive, computer-based mental activity is feasible in subjects with mild cognitive impairment and that larger trials are warranted.
Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]A randomized pilot experiment examined the neural substrates of response to cognitive training in participants with mild cognitive impairment (MCI). Participants performed exercises previously demonstrated to improve verbal memory and an active control group performed other computer activities. An auditory-verbal fMRI task was conducted before and after the two-month training program. Verbal memory scores improved significantly and left hippocampal activation increased significantly in the experimental group (gains in 5 of 6 participants) relative to the control group (reductions in all 6 participants). Results suggest that the hippocampus in MCI may retain sufficient neuroplasticity to benefit from cognitive training.
Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial. [2020]Mild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.
The Use of a Virtual Reality Platform for the Assessment of the Memory Decline and the Hippocampal Neural Injury in Subjects with Mild Cognitive Impairment: The Validity of Smart Aging Serious Game (SASG). [2020]Due to the lack of pharmacological treatment for dementia, timely detection of subjects at risk can be of seminal importance for preemptive rehabilitation interventions. The aim of the study was to determine the usability of the smart aging serious game (SASG), a virtual reality platform, in assessing the cognitive profile of an amnestic mild cognitive impairment (aMCI) population, its validity in discriminating aMCI from healthy controls (HC), and in detecting hippocampal degeneration, a biomarker of clinical progression towards dementia. Thirty-six aMCI and 107 HC subjects were recruited and administered the SASG together with a neuropsychological evaluation. All aMCI and 30 HC subjects performed also an MRI for hippocampal volume measurement. Results showed good usability of the SASG despite the low familiarity with technology in both groups. ROC curve analyses showed similar discriminating abilities for SASG and gold standard tests, and a greater discrimination ability compared to non-specific neuropsychological tests. Finally, linear regression analysis revealed that the SASG outperformed the Montreal cognitive assessment test (MoCA) in the ability to detect neuronal degeneration in the hippocampus on the right side. These data show that SASG is an ecological task, that can be considered a digital biomarker providing objective and clinically meaningful data about the cognitive profile of aMCI subjects.
Photo-Realistic Interactive Virtual Environments for Neurorehabilitation in Mild Cognitive Impairment (NeuroVRehab.PT): A Participatory Design and Proof-of-Concept Study. [2020]Mild cognitive impairment (MCI) is characterized by cognitive, psychological, and functional impairments. Digital interventions typically focus on cognitive deficits, neglecting the difficulties that patients experience in instrumental activities of daily living (IADL). The global conjecture created by COVID-19 has highlighted the seminal importance of digital interventions for the provision of healthcare services. Here, we investigated the feasibility and rehabilitation potential of a new design approach for creating highly realistic interactive virtual environments for MCI patients' neurorehabilitation. Through a participatory design protocol, a neurorehabilitation digital platform was developed using images captured from a Portuguese supermarket (NeuroVRehab.PT). NeuroVRehab.PT's main features (e.g., medium-sized supermarket, the use of shopping lists) were established according to a shopping behavior questionnaire filled in by 110 older adults. Seven health professionals used the platform and assessed its rehabilitation potential, clinical applicability, and user experience. Interviews were conducted using the think-aloud method and semi-structured scripts, and four main themes were derived from an inductive semantic thematic analysis. Our findings support NeuroVRehab.PT as an ecologically valid instrument with clinical applicability in MCI neurorehabilitation. Our design approach, together with a comprehensive analysis of the patients' past experiences with IADL, is a promising technique to develop effective digital interventions to promote real-world functioning.
Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial. [2022]This study evaluates the feasibility of delivering a virtual (online) falls prevention intervention for older adults with mild cognitive impairment (MCI).
Recruitment of a multi-site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial. [2023]Effective strategies to recruit older adults with mild cognitive impairment (MCI) into nonpharmacological intervention trials are lacking.
A cognitively enhanced online Tai Ji Quan training intervention for community-dwelling older adults with mild cognitive impairment: A feasibility trial. [2022]This study examines the feasibility, acceptability, and safety of a newly developed cognitive-enhancing Tai Ji Quan training intervention, delivered via remote videoconferencing, for older adults with mild cognitive impairment (MCI).
The Effect of Daily Practice of Puzzle-Game Apps on Cognition in Two Groups of Older Adults: A Pre-Post Experimental Study. [2023]There is an urgent need for non-pharmacological cognitive interventions to delay the onset and modify the progression of the cognitive deterioration of older adults with early stages of cognitive decline. 'Tablet Enhancement of Cognition and Health' (TECH) is such an intervention. We aimed to assess the suitability of TECH for older adults with and without mild cognitive impairment (MCI). Specifically, we wanted to explore the feasibility and to determine the initial effectiveness of TECH for older adults with Pre-Mild Cognitive Impairment (pre-MCI) as well as with MCI. This is pre-post experimental design, including two groups of older adults. Feasibility included group session attendance (adherence), self-training time (compliance), and satisfaction from the TECH intervention. The Montreal Cognitive Assessment (MoCA) assessed global cognition and the WebNeuro computerized battery assessed specific cognitive components. Twenty-eight participants with MCI (8 women, aged 65-87), and ten participants with pre-MCI (5 women, aged 65-86) participated in TECH. High adherence, compliance, and satisfaction were reported by both groups. Memory recall improved for the MCI group (z = -2.7 p = 0.006). In addition, for the MoCA an intermediate effect size (Cohen's d = 0.52) and a small effect (Cohen's d = 0.18) were found for the MCI and pre-MCI groups, respectively. Large to small effect size values for WebNeuro cognitive components were found for both groups. Both groups of older adults were motivated, performed daily self-training, which gave them enjoyment and a sense of control. TECH seems to have potential to preserve cognition over time. Additional research with a longer follow-up is needed to determine whether TECH can prevent cognitive decline in older adults with MCI but especially with pre-MCI.
Effectiveness of computer-based interventions for community-dwelling people with cognitive decline: a systematic review with meta-analyses. [2023]Cognitive deficits arise with age and can increase the risk for subjective cognitive decline (SCD) and mild cognitive impairment (MCI), which may result in dementia, leading to health problems, care dependency and institutionalization. Computer-based cognitive interventions (CCIs) have the potential to act as important counteraction functions in preserving or improving cognition concomitant to available pharmacological treatment. The aim was to assess the effectiveness of CCIs performed individually with a personal or tablet computer, game console, virtual, augmented, or mixed reality application on cognition in community-dwelling people with SCD, MCI and dementia.