Neuromodulation of Mind-Wandering in Depression

NCT04832685 | Active Not Recruiting FDA Device

• 1 other identifier: 2021P000704
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this proposed study is to investigate the feasibility and therapeutic potential of LIFUP in changing negative cognition in depression. Specifically, the investigators will study if modulating DMN activity can change maladaptive mind-wandering. The investigators hypothesize that DOWN-modulation of the posterior cingulate cortex (PCC), a key DMN node, will decrease DMN resting state functional connectivity, perfusion, and activation during a cognitive-affective task (description below). The investigators also hypothesize that DOWN-modulation of the PCC will be associated with decreased mind-wandering and increased mindfulness. Finally, the investigators hypothesize that the opposite will be true for UP-modulation of the PCC.

Conditions

Depression

Keywords

Ultrasound

Outcome Measures

Primary Outcomes (3)

• Negative self-judgment frequency during task

  Changes in reported frequency of negative self-judgments during the self-attribution task before and after sham and active modulation

  3 hours

• Default mode network activation during task

  Changes in Blood-Oxygen-Level Dependent activation in the default mode network during the self-attribution task before and after sham and active modulation

  3 hours

• Rumination

  Changes in Ruminative Responses Scale scores after the sham and active modulation sessions

  1 week

Secondary Outcomes (2)

• Depressive symptoms

  1 week

• Default mode network connectivity

  3 hours

Study Arms (2)

Active LIFUP

ACTIVE COMPARATOR

All participants will receive active modulation of the posterior cingulate cortex (PCC) during Visit 3 or 4 (order counterbalanced).

Device: BrainSonix Pulsar 1002

Sham LIFUP

SHAM COMPARATOR

All participants will receive sham modulation of the posterior cingulate cortex (PCC) during Visit 3 or 4 (order counterbalanced).

Device: BrainSonix Pulsar 1002

Interventions

BrainSonix Pulsar 1002 DEVICE

Device that delivers low intensity focused ultrasound

Active LIFUP; Sham LIFUP

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female
• Age 18-64
• Right-handed
• Normal or corrected-to normal vision and hearing
• For group with depression, current diagnosis of depression

You may not qualify if:

• Active significant medical illness or neurological disorder
• MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.)
• For healthy control group, any current or past history of psychiatric disorders

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: For sham sonication, a gel pad that absorbs ultrasound will be used with the transducer so that the ultrasound will not go through the skull and into the brain. For active sonication, a gel pad that allows the transmission of ultrasound waves will be used with the transducer. These gel pads look identical; this study will be double-blinded where study staff will not know which gel pad corresponded with active or sham LIFUP.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Neurotherapeutic, Department of Psychiatry

Model Details: Participants will be divided into 2 groups, healthy controls and participants with depression. Both groups will receive sham and active modulation (order counterbalanced).

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: March 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)