MCI, Aging
Conditions
Keywords
meditation, sleep, stress, attention, cognition, memory
Brief summary
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.
Interventions
DEVICEMediTrain
Participants will engage with a digital meditation app for 30m/day for 6wks. MediTrain is a tablet-based, meditation-inspired, cognitive training game aimed at improving self-regulation of internal attention and distractions. It was developed in collaboration with meditation thought-leader Jack Kornfield, and Zynga, a world-class video game company. It was created to make benefits of concentrative meditation more easily accessible to anyone, including complete novices. This is achieved by creating a game that yields quantifiable and attainable goals, provides feedback, and includes an adaptive algorithm to gradually increase difficulty as users improve.
Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
DEVICESleep monitor
Sleep Profiler devices are FDA-cleared reduced-montage EEG recording devices that will be used in accordance with its FDA clearance. They are completely non-invasive and are designed to be comfortable enough to wear all night without interfering with normal sleep. These devices enable quality sleep recordings in the comfort of people's homes, rather than required an overnight stay at a sleep lab at UCSF.
Sponsors
University of California, San Francisco
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* comfortably ambulatory healthy physical condition * normal or corrected to normal visual * auditory acuity * fluency in spoken English * Between 60-85 years old * No neurological or psychiatric disorders * No substance abuse * Not taking anti-depressants * Not taking anti-anxiety medication * No history of seizures * No color blindness * No glaucoma * No macular degeneration * No amblyopia (lazy eye) * No strabismus (cross eyed) * Aneurysm clip(s) * No Cardiac pacemaker * No Implanted cardioverter defibrillator (ICD) * No Electronic implant or device * No Magnetically-activated implant or device * No Neurostimulation system * No Spinal cord stimulator * No Internal electrodes or wires * No Bone growth/bone fusion stimulator * No Cochlear, otologic, or other ear implant * No Insulin or other infusion pump * No Implanted drug infusion device * No type of prosthesis (eye, penile, etc.) * No Heart valve prosthesis * No Eyelid spring or wire * No Artificial or prosthetic limb * No Metallic stent, filter, or coil * No Shunt (spinal or intraventricular) * No Vascular access port and/or catheter * No Radiation seeds or implants * No Swan-Ganz or thermodilution catheter * No Medication patch (Nicotine, Nitroglycerine) * No metallic fragment or metallic foreign body in/on the body that can not be removed * No Wire mesh implant * No Tissue expander (e.g., breast) * No Surgical staples, clips, or metallic sutures * No Joint replacement (hip, knee, etc.) * No Bone/joint pin, screw, nail, wire, plate, etc. * No IUD, diaphragm, or pessary * No Dentures or partial plates that can not be removed * No Tattoo or permanent makeup * No Body piercing jewelry * No Claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change on the Continuous Performance Task (CPT) over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | — |
| Mean change in sleep quality | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | Mean change in sleep quality (i.e., total sleep time / time in bed, therefore this measure incorporates latency to sleep onset, total sleep time, wake after sleep onset and early morning waking, with higher numbers associated with better sleep) over time \[Time Frame: baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants\] |
| Mean change in measures of stress reactivity over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | Measures of heart rate variability (HRV) and electrodermal activity (EDA) while participants perform a stress-inducing task |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Telomere length (quantified in peripheral blood cells) over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | 200 mL of blood will be collected from each participant before and after the intervention. Blood will be centrifuged for whole blood cell acquisition and stored at -80 °C for subsequent batch testing. Telomere length (T/S ratio) will be quantified in peripheral blood mononuclear cells. |
| Mean change on a distracted attention task over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | Mean performance on a distracted attention task will be compared pre and post intervention. Divided attention performance will be assessed using the Filter Task that places simultaneous demands on perceptual discrimination abilities and distraction filtering. |
| Mean change in Frontal Theta Power over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | Based on previous studies of meditation training and our preliminary data, we predict that MediTrain will lead to significantly enhanced midline frontal theta power during the TOVA in MCI as compared to OA. Beyond most prior studies, by collecting structural MRI data, we will be able to source-localize any observed changes in midline frontal theta. |
| Mean change in resting state networks over time | baseline, immediate follow-up, and at a 6 month follow-up in a subset of participants | We also expect MediTrain will augment intrinsic Default Mode Network (DMN) connectivity, both functionally (measured with resting fMRI111,112) and structurally (measured with DTI-based connectomes). This is hypothesized based on the known association between the DMN, |
Countries
United States
Contacts
CONTACTJoseph Chen, PhD
PRINCIPAL_INVESTIGATORDavid A Ziegler, PhD
University of California, San Francisco
PRINCIPAL_INVESTIGATORChristine Walsh, PhD
University of California, San Francisco
Outcome results
None listed