Neuromodulation for Depression

Overseen By Darin D Dougherty, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Significant illness, Neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for depression using a technique called LIFUP to alter brain function. The researchers aim to determine if adjusting activity in the brain's default mode network (DMN) can reduce negative thinking and enhance mindfulness. Right-handed individuals with normal vision and hearing who have a diagnosis of depression may be suitable participants. The study includes two groups: one receiving active treatment with the BrainSonix Pulsar 1002, a neuromodulation device, and the other receiving a sham (placebo-like) treatment for comparison. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could lead to new insights into treating depression.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this neuromodulation technique is safe for treating depression?

Research has shown that the BrainSonix Pulsar 1002, which uses low-intensity focused ultrasound pulsation (LIFUP), has been tested for safety and tolerability. In one study, 25 participants found the LIFUP treatment safe and easy to tolerate, with no serious side effects. However, while LIFUP appears promising, researchers continue to study its long-term safety and effectiveness. Current evidence suggests it is a safe option for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BrainSonix Pulsar 1002 because it offers a new approach to treating depression by using low-intensity focused ultrasound pulsation (LIFUP) to target the brain's posterior cingulate cortex (PCC). Unlike typical treatments for depression, which often involve medications or talk therapy, this method involves non-invasive brain modulation. This innovative technique could provide a more direct and potentially faster way to alleviate depressive symptoms by directly influencing brain activity, making it a promising alternative for those who may not respond well to traditional treatments.

What evidence suggests that this neuromodulation technique is effective for depression?

Research has shown that Low Intensity Focused Ultrasound Pulsation (LIFUP) might help people with depression by altering brain function. Studies have found that LIFUP can target specific brain areas related to depression symptoms. In this trial, participants will receive either active or sham modulation of the posterior cingulate cortex (PCC), a key brain area. Adjusting activity in the PCC might help reduce negative thoughts and increase mindfulness. Early results from other studies suggest that LIFUP is safe and could effectively treat mood disorders. While more research is needed, these initial findings are promising for using LIFUP to manage depression. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for right-handed adults aged 18-64 with a current diagnosis of depression. Participants must have normal or corrected-to-normal vision and hearing, without significant medical illnesses, neurological disorders, or MRI scan contraindications like metal implants.

Inclusion Criteria

My vision and hearing are normal, or corrected to be normal.

I am either male or female.

I am currently diagnosed with depression.

Exclusion Criteria

I have a serious illness or brain disorder.

You cannot have an MRI scan if you have metal implants, are claustrophobic or weigh more than 250 pounds.

I have never had a mood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires and practice cognitive tasks, followed by an MRI scan without LIFUP

1 week

1 visit (in-person)

Treatment

Participants undergo LIFUP sessions with active or sham modulation, including MRI scans and cognitive tasks

2 weeks

2 visits (in-person)

Follow-up

Participants complete follow-up questionnaires to assess mood and cognitive changes post-treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BrainSonix Pulsar 1002

Trial Overview The study tests the BrainSonix Pulsar 1002's ability to modulate brain activity in the posterior cingulate cortex (PCC) to potentially reduce negative mind-wandering associated with depression. It will explore if altering PCC activity can affect mindfulness and cognitive-affective tasks.

How Is the Trial Designed?

Group I: Active LIFUP Active Control 1 Intervention

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

Group II: Sham LIFUP Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0022395623004776

A pilot study of low-intensity focused ultrasound for ... This study provides preliminary evidence supporting the safety and efficacy of tfUS as a clinical intervention. These results warrant further investigation of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05147142

NCT05147142 | Low Intensity Focused Ultrasound: a New ... In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms ...

3. nature.com nature.com/articles/s41380-025-03033-w

Low-intensity transcranial focused ultrasound amygdala ... In tFUS/fMRI and rtFUS treatment sessions, participants received the same tFUS stimulation protocol with the Brainsonix Pulsar 1002 [57], which ...

4. fusfoundation.org fusfoundation.org/posts/clinical-trial-investigates-low-intensity-focused-ultrasound-for-depression/

Clinical Trial Investigates Low-Intensity ... A clinical trial is investigating the safety and feasibility of using low-intensity focused ultrasound to address anxiety and depression.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11973349/

Investigating low intensity focused ultrasound pulsation in ... LIFUP is administered using the Brainsonix BX Pulsar 1002 ... major depressive disorder: a secondary analysis of two randomized controlled trials.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04832685?tab=history&a=3

Record History | ver. 3: 2021-12-10 | NCT04832685 This table shows all the versions of this study record arranged in order by submitted date. To view one version of the study record, click the submitted ...