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Non-invasive Brain Stimulation

Non-invasive Brain Stimulation for Depression

N/A
Recruiting
Research Sponsored by San Francisco Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All participants must have normal (or corrected to normal) vision
All participants must be 18-65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions
Awards & highlights

Study Summary

This trial is testing a new way to treat depression by targeting neural circuitry involved in reward responsivity. If successful, this could lead to improved treatment methods for depression.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
TMS may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision is normal, or corrected to normal with glasses or contacts.
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I am between 18 and 65 years old.
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I have been diagnosed with major depressive disorder according to DSM-5.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions
This trial's timeline: 3 weeks for screening, Varies for treatment, and eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Targeted neurostimulation effects on reward feedback evaluation
Secondary outcome measures
Targeted neurostimulation effects on reward anticipation and late-stage evaluation

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Major Depression Disorder Group: iTBS-EEGExperimental Treatment1 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 Control1 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-EEGPlacebo Group1 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.

Find a Location

Who is running the clinical trial?

San Francisco Veterans Affairs Medical CenterLead Sponsor
48 Previous Clinical Trials
210,718 Total Patients Enrolled
4 Trials studying Depression
748 Patients Enrolled for Depression

Media Library

TMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05194098 — N/A
Depression Research Study Groups: Major Depression Disorder Group: iTBS-EEG, Major Depression Disorder Group: SHAM-EEG, Baseline Evaluation (Major Depressive Disorder and Healthy Control Groups)
Depression Clinical Trial 2023: TMS Highlights & Side Effects. Trial Name: NCT05194098 — N/A
TMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194098 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any spots available in this research project for new participants?

"Yes, this particular clinical trial is recruiting patients at the moment. The original posting was on October 1st, 2021 with the most recent update being on January 14th, 2022."

Answered by AI

Who meets the necessary requirements to be a part of this research project?

"45 individuals that have been diagnosed with MDD between the ages of 18 and 65 are required for this study. The most crucial eligibility requirement is a previous diagnosis of MDD."

Answered by AI

Are people who are over 35 years old eligible to participate in this clinical trial?

"To be eligible for this study, applicants must be aged 18-65. Out of the 1290 total clinical trials, this age group comprises 203 trials while 987 trials are for patients outside of this age range."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
San Francisco VA Medical Center
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried Prozac, Lamictal, psychotherapy, and oral ketamine with insufficient results. I want to live with less misery.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functioning in Depression
Susanna Fryer, PhD 2021. "Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functioning in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05194098.
~6 spots leftby Sep 2024
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