Non-invasive Brain Stimulation for Depression

Overseen By Jason B Hemmerle, MBA

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: San Francisco Veterans Affairs Medical Center

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special type of brain stimulation to target areas involved in reward and motivation in people with major depressive disorder. The goal is to activate these underactive brain areas to improve their response to rewards, potentially helping to alleviate some symptoms of depression. Deep Brain Stimulation (DBS) was originally developed to manage movement disorders like Parkinson's Disease but has shown promise in treating depression by targeting specific brain areas.

Research Team

Susanna L Fryer, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults aged 18-65 with major depressive disorder (MDD) as defined by the DSM-5. Participants must have normal vision or corrected-to-normal vision, be safety screened for TMS and MRI procedures, and have been on a stable psychiatric medication regime for over a month.

Inclusion Criteria

My vision is normal, or corrected to normal with glasses or contacts.

I am between 18 and 65 years old.

I have been on the same psychiatric medication for over a month.

Exclusion Criteria

Participants with MDD must not have past or present DSM-5 (SCID-5) Gambling Disorder

Substance dependence within the past year, current (past 3 months) substance misuse, or failed urine toxicology on the day of neuroimaging sessions

I have major depression but no history of bipolar disorder.

Treatment Details

Interventions

• SHAM TMS stimulation (Procedure)
• TMS (Non-invasive Brain Stimulation)

Trial Overview The study tests intermittent theta burst stimulation (iTBS) using a MagVenture MagPro R30 device to target the brain's reward system in people with MDD. It compares active iTBS treatment to SHAM (inactive) stimulation to see how it affects depression symptoms.

Participant Groups

Group I: Major Depression Disorder Group: iTBS-EEG Experimental Treatment 1 Intervention

Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: intermittent theta stimulation (iTBS): the investigators will stimulate a dorsomedial prefrontal cortex target at the scalp location (0x 60y 60z). Standard iTBS of 50Hz triplet bursts, 5 times each second with a 2 s on / 8 s off duty cycle for 600 pulses per hemisphere (1200 pulses total) will be applied for a total stimulation time of 6:40 minutes, per session; total session length, including setup is 10-15 min.

Group II: Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups) Active Control 1 Intervention

HC and MDD participants will have visits for clinical assessment and a baseline EEG session to complete reward processing tasks (SLOT AND MID). The SLOT task is a 288-trial EEG task developed in our laboratory. Design features mimic structural characteristics common to real-word slot machines, including sound effects and visualizations, and the display consists of 3 sequentially populated slot reels. Participants initiate each trial via button press, after which timing of the slot reels is automated, such that reward outcome is independent of task performance. The MID task is a 130-trial EEG task designed to model anticipatory and consummatory sub-stages of reward processing in the context of participants being rewarded based on their response times to a cued target detection task.

Group III: Major Depression Disorder Group: SHAM-EEG Placebo Group 1 Intervention

Device: MagVenture MagPro R30 device with a Cool-DB80 A/P coil (Farum, Denmark) Stimulation: sham stimulation (SHAM): Sham stimulation will entail the same procedures for the active stimulation day, but with the sham side of the DB-80 A/P placed exactly on the same anatomical target in the same position and duration, but without any active stimulation. \*Note, iTBS and SHAM stimulation sessions will occur on separate days scheduled one week apart (counterbalanced, across subjects). The two stimulation visits follow identical procedures (with the sole difference being active vs. sham rTMS stimulation), with each followed directly by post-stimulation EEG assessment with SLOT and MID tasks.

TMS is already approved in Canada for the following indications:

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

San Francisco Veterans Affairs Medical Center

Lead Sponsor

Trials

52

Recruited

211,000+