What is the mechanism of action of this treatment?

Common treatments for Major Depressive Disorder (MDD) include pharmacotherapy, psychotherapy, and neuromodulation techniques like transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). TMS, similar to the aiTBS being studied, modulates brain activity by using magnetic fields to stimulate nerve cells in the brain, particularly targeting areas involved in mood regulation. ECT, on the other hand, induces controlled seizures through electrical currents to achieve therapeutic effects. Understanding these mechanisms is crucial for MDD patients as it helps in selecting the most appropriate treatment based on how these interventions can alter brain activity to alleviate depressive symptoms, potentially leading to better outcomes and personalized care.

What side effects are associated with this type of intervention?

Common treatments for Major Depressive Disorder (MDD) include neuromodulation techniques like Transcranial Magnetic Stimulation (TMS) and its variant, Accelerated Intermittent Theta Burst Stimulation (aiTBS). Side effects of TMS and aiTBS are generally mild and may include scalp discomfort, headaches, and, rarely, seizures. Antidepressant medications, another common treatment, can cause side effects such as nausea, weight gain, sexual dysfunction, and insomnia. Psychotherapy, while generally safe, may lead to emotional discomfort as patients confront distressing thoughts and feelings. Each treatment option has its own risk profile, and patients should discuss these with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several neuromodulatory treatments for Major Depressive Disorder (MDD) that are similar to Accelerated Intermittent Theta Burst Stimulation (aiTBS). One notable example is Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has been approved for patients who have not responded to traditional antidepressant medications. Another related treatment is Vagus Nerve Stimulation (VNS), which involves electrical stimulation of the vagus nerve to influence brain activity. These treatments offer alternative options for patients with treatment-resistant depression by directly modulating brain activity.

What other types of research exist?

Promising, novel alternatives to aiTBS for Major Depressive Disorder include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown efficacy in reducing symptoms in treatment-resistant depression. 2) Transcranial Direct Current Stimulation (tDCS), which has demonstrated potential in reducing negative symptoms in clinical trials. 3) Electroconvulsive Therapy (ECT), which remains a robust option for treatment-resistant cases. These alternatives offer different mechanisms of action and may be considered based on individual patient needs and responses.

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Other

Individualized TMS for Depression (AINT Trial)

Phase 2

Recruiting

Led By Joseph J Taylor, MD, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests aiTBS, a magnetic brain stimulation method, on patients with depression that hasn't responded to other treatments. The treatment uses magnetic pulses to reset brain activity and improve mood. Participants will receive aiTBS either guided by brain scans or by physical measurements of the head. Intermittent Theta Burst Stimulation (iTBS) is a newer form of repetitive Transcranial Magnetic Stimulation (rTMS) that has shown potential for faster and more intense effects in treating depression.

Who is the study for?

This trial is for adults with major depressive disorder who haven't responded well to other treatments. They must speak English, maintain their usual caffeine intake, not use tobacco on treatment days, and avoid alcohol before MRI and TMS sessions. Pregnant individuals or those trying to become pregnant cannot participate.

What is being tested?

The study tests aiTBS (a type of brain stimulation) for depression treatment effectiveness. Participants will receive aiTBS without knowing if the targeted area was chosen using neuroimaging or standard head measurements.

What are the potential side effects?

aiTBS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and temporary but can vary between individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Beck Anxiety Inventory (BAI)

Beck Depression Inventory (BDI)

Change in resting state functional connectivity in the depression network

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: sham individualized resting state functional connectivity targetingExperimental Treatment1 Intervention

Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with head measurements (i.e., Beam F3)

Group II: real individualized resting state functional connectivity targetingExperimental Treatment1 Intervention

Participants in this group will receive aiTBS with neuronavigation to a treatment target identified with individualized resting state functional connectivity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

transcranial magnetic stimulation

2013

Completed Phase 2

~760

Do I qualify?Apply below to find out

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 Major Depressive Disorder (MDD) include pharmacotherapy, psychotherapy, and neuromodulation techniques like transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). TMS, similar to the aiTBS being studied, modulates brain activity by using magnetic fields to stimulate nerve cells in the brain, particularly targeting areas involved in mood regulation. ECT, on the other hand, induces controlled seizures through electrical currents to achieve therapeutic effects. Understanding these mechanisms is crucial for MDD patients as it helps in selecting the most appropriate treatment based on how these interventions can alter brain activity to alleviate depressive symptoms, potentially leading to better outcomes and personalized care.