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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+