Accelerating Cognitive Gains From Digital Inverventions With Noninvasive Brain Stimulation

Not Applicable

Recruiting

• Conditions: Aging; MCI
• Interventions: Device: Worder; Device: MediTrain; Device: noninvasive neurostimulation device; Device: wrist worn multi-sensor watches

• Registration Number: NCT06633952
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-13
• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MediTrain	noninvasive neurostimulation device	-
MediTrain	wrist worn multi-sensor watches	-
Worder	Worder	-
Worder	noninvasive neurostimulation device	-
Worder	wrist worn multi-sensor watches	-
MediTrain	MediTrain	-

Primary Outcome Measures

Name	Time	Method
Mean change on the Continuous Performance Task (CPT) over time	baseline and immediate follow-up	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').

Secondary Outcome Measures

Name	Time	Method
Mean change in Telomere length	baseline and immediate follow-up	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 and immediate follow-up	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 and immediate follow-up	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 and immediate follow-up	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

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States