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Neuromodulation

Neuromodulation for Depression

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal or corrected-to normal vision and hearing
For group with depression, current diagnosis of depression
Must not have
Active significant medical illness or neurological disorder
For healthy control group, any current or past history of mood disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours

Summary

This trial is testing if a new treatment, LIFUP, can change negative cognition in depression by modulating the activity of the brain's Default Mode Network. The study will investigate if this treatment can decrease mind-wandering and increase mindfulness.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from wearing the device, headache, dizziness, or other sensations related to non-invasive brain stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision and hearing are normal, or corrected to be normal.
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I am currently diagnosed with depression.
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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious illness or brain disorder.
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I have never had a mood disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Default mode network activation during task
Negative self-judgment frequency during task
Rumination
Secondary study objectives
Default mode network connectivity
Depressive Symptoms

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active LIFUPActive Control1 Intervention
All participants will receive active modulation of the posterior cingulate cortex (PCC) during Visit 3 or 4 (order counterbalanced).
Group II: Sham LIFUPPlacebo Group1 Intervention
All participants will receive sham modulation of the posterior cingulate cortex (PCC) during Visit 3 or 4 (order counterbalanced).

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,000 Previous Clinical Trials
13,308,468 Total Patients Enrolled
190 Trials studying Depression
33,812 Patients Enrolled for Depression

Media Library

BrainSonix Pulsar 1002 (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04832685 — N/A
Depression Research Study Groups: Active LIFUP, Sham LIFUP
Depression Clinical Trial 2023: BrainSonix Pulsar 1002 Highlights & Side Effects. Trial Name: NCT04832685 — N/A
BrainSonix Pulsar 1002 (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04832685 — N/A
~17 spots leftby Apr 2025
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