Accelerating Cognitive Gains From Digital Inverventions With Noninvasive Brain Stimulation

NCT06633952 | Active Not Recruiting FDA Device

• 2 other identifiers: AG080528R61AG080528
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; MCI

Keywords

healthy aging; cognitive decline; prevention; brain stimulation; attention; memory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mean change in Telomere length

  baseline and immediate follow-up

• Mean change on a distracted attention task over time

  baseline and immediate follow-up

• Mean Change in Frontal Theta Power over time

  baseline and immediate follow-up

• Mean change in resting state networks over time

  baseline and immediate follow-up

Other Outcomes (7)

• Mean change on the Adaptive Cognitive Evaluation (ACE) over time

  baseline and immediate follow-up

• Mean change in continuous recordings of sleep and stress metrics.

  baseline and immediate follow-up

• Mean change in Change in Mnemonic Discrimination over time

  baseline and immediate follow-up

Study Arms (2)

MediTrain

EXPERIMENTAL

Device: MediTrain; Device: noninvasive neurostimulation device; Device: wrist worn multi-sensor watches

Worder

EXPERIMENTAL

Device: Worder; Device: noninvasive neurostimulation device; Device: wrist worn multi-sensor watches

Interventions

MediTrain DEVICE

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.

MediTrain

Worder DEVICE

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.

Worder

noninvasive neurostimulation device DEVICE

A noninvasive neurostimulation device will be used to deliver theta frequency stimulation or sham stimulation to the frontal part of the brain.

MediTrain; Worder

wrist worn multi-sensor watches DEVICE

Stress and sleep data will be recorded at home throughout the intervention using FDA-approved wrist worn multi-sensor watches.

MediTrain; Worder

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Ziegler, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)