What side effects are associated with this type of intervention?

Common treatments for depression, such as Electroconvulsive Therapy (ECT) and repetitive Transcranial Magnetic Stimulation (rTMS), have known side effects. ECT can cause cognitive impairments, including memory loss and confusion, which are generally short-lived but more pronounced with bilateral ECT compared to unilateral ECT. rTMS, including techniques like theta burst stimulation, may cause headaches, scalp discomfort, and, in rare cases, seizures. Both treatments are generally well-tolerated, but the side effects can vary based on the specific method and individual patient factors.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of depression, including Electroconvulsive Therapy (ECT) and Repetitive Transcranial Magnetic Stimulation (rTMS). ECT has been recognized for its efficacy in both unipolar and bipolar depression, particularly in treatment-resistant cases. rTMS, another FDA-approved treatment, uses magnetic fields to stimulate nerve cells in the brain and has shown effectiveness in major depressive disorder. While Bilateral Accelerated Theta Burst Stimulation (aTBS) is still under investigation, it is a form of rTMS that delivers rapid bursts of magnetic pulses and is being studied for its potential benefits in reducing suicidal ideation in treatment-resistant depression.

What other types of research exist?

Promising, novel alternatives to Bilateral Accelerated Theta Burst Stimulation (aTBS) for depression in 2024 include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown efficacy in reducing negative symptoms in several trials. 2) Deep Brain Stimulation (DBS), particularly targeting areas like the subcallosal cingulate, which has shown clinical improvements in treatment-resistant depression. 3) Repetitive Transcranial Magnetic Stimulation (rTMS), which has mixed but promising results in reducing symptoms of depression.

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Non-invasive Brain Stimulation

Accelerated Theta Burst Stimulation for Suicidal Thoughts (COMBAT-SI Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-70 years old

Psychiatric illness due to a general medical condition (GMC) has been ruled out during initial assessment

Must not have

Not capable to consent to treatment and/or not suitable for outpatient treatment

Currently pregnant or lactating, or woman of childbearing age without adequate birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months

Awards & highlights

Summary

This trial is testing a new brain stimulation treatment to help people with hard-to-treat depression who have suicidal thoughts. The treatment uses magnetic pulses to stimulate specific brain areas several times. Researchers hope this will improve brain communication and reduce suicidal thoughts. This type of brain stimulation has been studied before and has shown positive effects.

Who is the study for?

This trial is for adults aged 18-70 with major depression and ongoing suicidal thoughts, who haven't responded to at least two antidepressants. Participants must pass safety screenings for transcranial magnetic stimulation (TMS) and MRI, be outpatient-capable, and not have severe medical or neurological conditions. Pregnant women or those unable to use birth control are excluded.

What is being tested?

The study tests the effectiveness of accelerated Theta Burst Stimulation (aTBS), a type of TMS therapy on suicidal ideation in people with treatment-resistant depression. It compares bilateral aTBS over the DLPFC region of the brain versus aiTBS over just the left side.

What are the potential side effects?

Potential side effects may include discomfort at stimulation site, headache, lightheadedness, seizures (rare), hearing problems if ear protection isn’t used during treatment, and temporary changes in thinking or mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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My mental health issues are not caused by another medical condition.

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I have been diagnosed with a major depressive episode and my depression is severe.

Exclusion Criteria

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

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I am unable to consent to treatment or not suitable for outpatient care.

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I am not pregnant, breastfeeding, and if I can have children, I use birth control.

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I have been diagnosed with a serious mental health condition like bipolar disorder or schizophrenia.

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I take more than 2 mg of lorazepam daily or any amount of seizure medication.

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I do not have any major unstable illnesses or metal implants in or near my head that can't be removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in scores on the suicide scale index (SSI) from baseline

Secondary study objectives

Categorical suicidal clinical outcomes

Neurophysiological measures of cortical inhibition, N100, short interval cortical inhibition, and cortical evoked activity

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bilateral aTBSExperimental Treatment1 Intervention

Patients will receive Bilateral accelerated theta-burst stimulation bilaterally for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions.

Group II: Unilateral aiTBSActive Control1 Intervention

Patients will receive unilateral accelerated theta-burst stimulation to the left side for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions. There will be a right DLPFC sham component to this treatment arm for all treatment sessions.

0 / 8Eligibility 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 pharmacotherapy, psychotherapy, and neuromodulation techniques. Pharmacotherapy often involves antidepressants like SSRIs and SNRIs, which work by increasing the levels of serotonin and norepinephrine in the brain, respectively, to improve mood and emotional stability. Psychotherapy, such as Cognitive Behavioral Therapy (CBT), helps patients identify and change negative thought patterns and behaviors. Neuromodulation techniques, such as Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS), including Bilateral Accelerated Theta Burst Stimulation (aTBS), modulate brain activity to alleviate depressive symptoms. aTBS, specifically, targets the dorsolateral prefrontal cortex to enhance cortical inhibition, which can rapidly reduce suicidal ideation and depressive symptoms. Understanding these mechanisms is crucial for patients as it helps them and their doctors make informed decisions about the most appropriate and effective treatment options based on their specific symptoms and treatment history.

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