The STRENGTHEN Study

Summary

This study uses two different types of interventions including electrical brain stimulation delivered during sleep, and brief, daily meditation training. The investigators are trying to figure out whether these techniques, either alone or in combination with each other, can positively impact the brain networks that support our ability to think flexibly and to regulate our emotions. 48 participants will be enrolled into each of 2 phases and can expect to be on study for up to 9 months.

Conditions

• Cognitive Flexibility
• Emotional Regulation

Interventions

OTHER

Healthy Minds Program

Participants will follow daily instructions from the Healthy Minds Program at home for four weeks, including guided meditation exercises.

OTHER

Sham Meditation Didactic Material

Participants will listen to lessons from the Healthy Minds Program at home for four weeks, which will not include any actual meditation exercises.

DEVICE

Sham Stimulation in Lab

On two nights each week during the four weeks of the intervention, participants will sleep in the lab and undergo sham TES-TI stimulation for approximately 10 hours per night

DEVICE

Stimulation in Lab

Participants will sleep in the lab and undergo active TES-TI stimulation for approximately 10 hours per night.

DEVICE

MRI Scanner

Imaging protocol will include: structural T1-weighted and T2-weighted images, resting-state functional MRI, task-based functional MRI, and multi-shell diffusion weighted MRI, total scan time will be approximately 2 hours

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Richard Davidson, PhD · University of Wisconsin, Madison

• Giulio Tononi, MD, PhD · University of Wisconsin, Madison

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-06

Primary Completion

2026-04-24

Completion

2026-04-24

FDA Device

Yes

Countries

• United States

Study Locations