What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment for depression that uses magnetic fields to stimulate nerve cells in the brain. Common side effects of TMS include mild headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles, and lightheadedness. Serious side effects are rare but can include seizures, particularly in individuals with epilepsy. Other neuromodulation techniques, such as noninvasive vagus nerve stimulation (nVNS) and remote electrical neuromodulation, may cause mild adverse events like a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain. Overall, these treatments are generally well-tolerated with a low incidence of serious adverse effects.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) has received FDA approval for the treatment of major depressive disorder, particularly in patients who have not responded to traditional antidepressant medications. TMS uses magnetic fields to stimulate nerve cells in the brain, specifically targeting areas involved in mood regulation. The efficacy of TMS has been demonstrated in multiple clinical trials, showing significant improvement in depressive symptoms. Other neuromodulation techniques, such as electroconvulsive therapy (ECT), are also FDA-approved for treatment-resistant depression, but TMS is favored for its non-invasive nature and fewer side effects.

What other types of research exist?

Promising alternatives to TMS for treating depression include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown significant pain reduction in migraine trials and may have potential for mood regulation. 2) Remote Electrical Neuromodulation, which uses a device controlled by a smartphone to apply nonpainful electrical stimulation and has shown efficacy in reducing migraine pain. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown benefits in treating episodic migraine and may be applicable for depression. These methods are non-invasive and have demonstrated positive outcomes in related conditions, suggesting potential for depression treatment.

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Non-invasive Brain Stimulation

Non-invasive Brain Stimulation for Depression

N/A

Recruiting

Led By Susanna L Fryer, PhD

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

Must not have

Participants with MDD must not have past or present DSM-5 (SCID-5) Bipolar and Related Disorders Diagnosis

Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology), or other physical conditions if they preclude participation in EEG, TMS, or MRI protocols (e.g. peripheral nerve damage, limb paralysis etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have major depression but no history of bipolar disorder.

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I do not have major medical conditions that would prevent me from undergoing EEG, TMS, or MRI tests.

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My depression does not include psychotic features.

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I have major depression but no history of schizophrenia or similar conditions.

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I have had neurological issues, like seizures or head injuries affecting my brain function.

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I have claustrophobia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eeg measurements are collected directly after neurostimulation (itbs vs sham) sessions

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Targeted neurostimulation effects on reward feedback evaluation

Secondary study objectives

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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for depression include medications like antidepressants, psychotherapy, and neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS). Antidepressants typically work by altering neurotransmitter levels in the brain, such as serotonin, norepinephrine, and dopamine, to improve mood and emotional state. Psychotherapy, including cognitive-behavioral therapy (CBT), helps patients identify and change negative thought patterns and behaviors. TMS uses magnetic fields to stimulate nerve cells in specific brain regions involved in mood regulation, such as the dorsolateral prefrontal cortex. Understanding these mechanisms is crucial for depression patients as it helps tailor treatments to individual needs, potentially improving efficacy and reducing side effects.