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Clinical Trial NCT06633952 for Aging, MCI is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Accelerating Cognitive Gains From Digital Inverventions With Noninvasive Brain Stimulation

Recruiting
Clinical Trial NCT06633952 is an interventional study for Aging, MCI that is recruiting. It started on 13 September 2024 with plans to enroll 90 participants. Led by University of California, San Francisco, it is expected to complete by 1 December 2025. The latest data from ClinicalTrials.gov was last updated on 9 October 2024.
Brief Summary
The overall goal of this project is to collect pilot feasibility and early efficacy data showing improvements in cognition and wellbeing in adults with mild cognitive impairment (MCI) through a combination treatment of non-invasive brain stimulation (transcranial alternating current stimulation (tACS)) and a one of two digital cognitive interventions.
Official Title

Accelerating Cognitive Gains From Digital Meditation With Noninvasive Brain Stimulation: A Pilot Study in MCI

Conditions
AgingMCI
Other Study IDs
NCT ID Number
NCT06633952
Start Date (Actual)
2024-09-13
Last Update Posted
2024-10-09
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
healthy aging
cognitive decline
prevention
brain stimulation
attention
memory
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMediTrain
Meditrain
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.
Noninvasive Neurostimulation Device
A noninvasive neurostimulation device will be used to deliver theta frequency stimulation or sham stimulation to the frontal part of the brain.
Wrist Worn Multi-sensor Watches
Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
ExperimentalWorder
Worder
Worder was designed to enhance visual motor and visual spatial skills in individuals of all ages and cognitive abilities. Visual processing is required for all cognitive abilities that involve vision including attention, working memory, and task management. Worder's goal is to improve cognitive function more broadly by developing this critical skill underlying multiple abilities.
Noninvasive Neurostimulation Device
A noninvasive neurostimulation device will be used to deliver theta frequency stimulation or sham stimulation to the frontal part of the brain.
Wrist Worn Multi-sensor Watches
Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mean change on the Continuous Performance Task (CPT) over time
The CPT is a 23-minute task, where participants are instructed to respond to target stimuli (squares at the top of the screen) and withhold responses to non-target stimuli (squares at the bottom of the screen). Performance will be quantified as: (1) mean reaction times, (2) standard deviation of reaction times (RTV), and (3) d-prime (comparing correct target detections or 'hits' to incorrect non-target detections or 'false alarms').
baseline and immediate follow-up
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Mean change in Telomere length
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.
baseline and immediate follow-up
Mean change on a distracted attention task over time
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.
baseline and immediate follow-up
Mean Change in Frontal Theta Power over time
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.
baseline and immediate follow-up
Mean change in resting state networks over time
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
baseline and immediate follow-up
Eligibility 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
University of California, San Francisco logoUniversity of California, San Francisco704 active trials to explore
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
Study Central Contact
Contact: David Ziegler, PhD, 415-476-2164, [email protected]
1 Study Locations in 1 Countries

California

University of California San Francisco, San Francisco, California, 94158, United States
David Ziegler, PhD, Contact, 415-476-2164, [email protected]
Recruiting