NCT07220655

Brief Summary

Our primary goal is to investigate the role of Low-Intensity Focused Ultrasound (LIFU) neuromodulation on deep brain targets, and its potential to improve cognition

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jun 2024Jul 2028

Study Start

First participant enrolled

June 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

4.1 years

First QC Date

October 22, 2025

Last Update Submit

October 22, 2025

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

  • Deep Brain Targets Reached

    MRI-based readouts testing whether LIFU neuromodulation can successfully engage targets in deep brain

    Hour 1

  • Multi-Source Interference Test (MSIT) Performance

    Behavioral readouts of successful LIFU neuromodulation of our target regions

    Hour 1

  • 28/Posit Science Performance

    Behavioral readouts of successful LIFU neuromodulation of our target regions

    Hour 1

Study Arms (1)

Low-Intensity Focused Ultrasound

EXPERIMENTAL
Device: Low-Intensity Focused Ultrasound (FUS or LIFU)

Interventions

Low-Intensity Focused Ultrasound (FUS or LIFU)DEVICE

We will use an established, currently-marketed device to deliver LIFU neuromodulation.

Low-Intensity Focused Ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Speak English (as assessed by their ability to read/answer survey questions)
  • May be required to score in the appropriate range on self-report measures

You may not qualify if:

  • They have a neurological disorder which may impact their fMRI scan or cause their reaction to LIFU to differ from that of healthy adults.
  • They take any psychoactive medication.
  • They are unable to undergo fMRI scanning due to a contraindication such as claustrophobia, unremovable piercings, pregnancy, the presence of medical devices such as pacemakers, or a movement or sleep disorder.
  • Are pregnant, or may have reason to believe that they are pregnant.
  • They have a diagnosis of a psychiatric condition other than depression or anxiety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

  • Michael Bronstein

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam Freedman

CONTACT

tel:612-625-3330mfreedma@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2025

First Posted

October 24, 2025

Study Start

June 1, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

October 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)