What side effects are associated with this type of intervention?

Transcranial Magnetic Stimulation (TMS) is generally well-tolerated, with common side effects including mild headaches, scalp discomfort at the stimulation site, and brief lightheadedness. Serious side effects are rare but can include seizures, particularly in individuals with epilepsy. Compared to pharmacological treatments for depression, which often have side effects like weight gain, sexual dysfunction, gastrointestinal issues, and sedation, TMS offers a non-invasive alternative with a different side effect profile. Other neuromodulation techniques, such as electroconvulsive therapy (ECT), can have more severe side effects, including memory loss and confusion. Overall, TMS provides a viable option for patients who may not tolerate or respond to traditional antidepressant medications.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) is an FDA-approved treatment for depression that uses magnetic fields to stimulate nerve cells in the brain. It is particularly used for patients with treatment-resistant depression who have not responded to traditional therapies such as antidepressants. TMS has been enhanced by functional MRI (fMRI) for better targeting of neural activity. Other FDA-approved treatments for depression include various pharmacotherapies like SSRIs (e.g., fluoxetine, sertraline), SNRIs (e.g., venlafaxine), and atypical antipsychotics (e.g., aripiprazole) used as adjuncts. Electroconvulsive therapy (ECT) is another FDA-approved non-pharmacological treatment for severe depression, though it is more invasive compared to TMS.

What other types of research exist?

Promising, novel alternatives to Transcranial Magnetic Stimulation (TMS) for depression include: 1) Transcutaneous Supraorbital Nerve Stimulation (tSNS), which has shown efficacy in reducing migraine pain and may have potential for depression treatment. 2) Remote Electrical Neuromodulation (REN), which uses nonpainful electrical skin stimulation and has demonstrated positive outcomes in migraine trials. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has shown benefits in acute treatment of episodic migraine and may be applicable for depression. These alternatives offer non-invasive options with varying mechanisms of action and have shown promise in clinical settings.

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Neuromodulation

TMS for Depression (TMS-LLD Trial)

N/A

Recruiting

Research Sponsored by University of New Mexico

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 week 3 post-treatment assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve the effectiveness of a non-invasive brain stimulation technique for elderly patients with late-life depression by using imaging technology to precisely target brain areas involved in mood regulation. The goal is to provide a safer and more effective treatment option for those who have not responded well to traditional therapies. This brain stimulation technique has been studied for many years as a treatment for depression, showing potential benefits especially in older patients.

Who is the study for?

This trial is for English-speaking individuals aged 60-79 with major depressive disorder diagnosed by a psychiatrist, currently experiencing a depressive episode. Excluded are pregnant women, those with bipolar or psychotic disorders, recent hospitalization, neurosurgery history, ECT in the last three months, MRI contraindications, substance abuse within three months, seizure history or neurological disorders.

What is being tested?

The study tests how to improve transcranial magnetic stimulation (TMS), an existing treatment for late-life depression. It uses fMRI to personalize TMS targeting and assess its effectiveness in an open-label setting where all participants receive the intervention.

What are the potential side effects?

While not specified here, common side effects of rTMS may include headache or scalp discomfort at the site of stimulation. Rarely it can cause seizures or hearing loss if ear protection isn't used during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 3 post-treatment assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 3 post-treatment assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 post-treatment assessment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Anterior Cingulate Cortex (ACC) Connectivity

Secondary study objectives

Depression Severity

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: rTMSExperimental Treatment1 Intervention

Subjects will receive rTMS to the area of the DLPFC most anticorrelated with the ACC.

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

Transcranial Magnetic Stimulation (TMS) is a non-invasive treatment for depression that uses magnetic fields to stimulate nerve cells in the brain, particularly targeting areas involved in mood regulation. Enhanced by functional MRI (fMRI), TMS can be more precisely targeted to the affected brain regions, potentially increasing its efficacy. This matters for depression patients because it offers a treatment option that can be tailored to their specific neural activity patterns, potentially leading to better outcomes with fewer side effects compared to traditional pharmacotherapy. Understanding these mechanisms helps patients and clinicians make informed decisions about incorporating TMS into their treatment plans, especially for those who have not responded to conventional treatments.

[Historical review and recent research trends of the antidepressant repetitive transcranial magnetic stimulation (rTMS)].