What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally well-tolerated, with common side effects including headache, scalp discomfort at the stimulation site, and, rarely, seizures. Selective Serotonin Reuptake Inhibitors (SSRIs) can cause nausea, insomnia, sexual dysfunction, and weight gain. Tricyclic Antidepressants (TCAs) may lead to dry mouth, blurred vision, constipation, urinary retention, and cardiovascular issues. Electroconvulsive Therapy (ECT) can result in short-term memory loss, confusion, and physical side effects related to anesthesia. Each treatment has its own risk profile, and the choice of therapy should be tailored to the individual patient's needs and medical history.

What prior FDA approvals exist?

Repetitive Transcranial Magnetic Stimulation (rTMS) has been approved by the FDA for the treatment of major depressive disorder, particularly in patients who have not responded to traditional antidepressant medications. rTMS uses magnetic fields to stimulate nerve cells in the brain, aiming to improve symptoms of depression. Other neuromodulation techniques, such as Transcranial Direct Current Stimulation (tDCS) and Vagus Nerve Stimulation (VNS), have also been explored for their potential benefits in treating depression. Pharmacological treatments for treatment-resistant depression often involve augmentation strategies, including the use of atypical antipsychotics, mood stabilizers, and combination therapies with antidepressants.

What other types of research exist?

Promising, novel alternatives to Accelerated rTMS for depression patients include: 1) Transcranial Magnetic Stimulation (TMS) with different protocols, such as theta burst stimulation, which has shown efficacy in treatment-resistant depression. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which has demonstrated benefits in acute treatment of episodic migraine and may have potential for depression. 3) Remote Electrical Neuromodulation (REN), which has been effective in reducing acute migraine pain and could be explored for depression treatment. These alternatives offer nonpharmacologic options with varying degrees of evidence supporting their use.

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Non-invasive Brain Stimulation

rTMS for Treatment-Resistant Depression

N/A

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

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 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses rTMS, a method that stimulates brain cells with magnetic fields, to treat patients with severe and milder treatment-resistant depression. The goal is to see if this can improve their mood by enhancing brain connectivity. Repetitive transcranial magnetic stimulation (rTMS) is emerging as a new treatment for mood disorders, particularly depression.

Who is the study for?

This trial is for adults aged 20-65 with severe, long-lasting depression that hasn't improved after trying at least six different antidepressants and other treatments like psychotherapy or ECT. They must have a specific score on a depression rating scale to qualify. People can't join if they're pregnant, unable to consent, have MRI contraindications, other major medical/psychiatric issues not related to depression, history of psychosis or substance dependence recently.

What is being tested?

The study tests an 'accelerated' rTMS protocol using brain imaging before treatment. It aims to see if those with ultra-treatment resistant depression respond differently than those with less severe cases and whether this intense one-week rTMS treatment can help where surgery might be the next option.

What are the potential side effects?

rTMS may cause discomfort at the site of stimulation, headache, lightheadedness, or seizures in rare cases. Most side effects are mild and improve shortly after each session.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Imaging

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerated iTBS treatmentExperimental Treatment1 Intervention

accelerated iTBS treatment protocol over 5 consecutive days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

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

Repetitive transcranial magnetic stimulation (rTMS) uses magnetic fields to stimulate nerve cells in the brain, particularly targeting the prefrontal cortex, which is involved in mood regulation. This stimulation can help improve symptoms of depression by enhancing neural activity and connectivity in this region. Pharmacotherapy, commonly involving antidepressants, works by altering neurotransmitter levels (such as serotonin, norepinephrine, and dopamine) to improve mood and emotional state. Electroconvulsive therapy (ECT) induces controlled seizures through electrical currents, which can rapidly alleviate severe depressive symptoms by causing changes in brain chemistry and neural circuits. Understanding these mechanisms is crucial for depression patients as it helps them and their healthcare providers make informed decisions about the most appropriate and effective treatment options based on their specific condition and response to previous treatments.