What side effects are associated with this type of intervention?

Common treatments for depression, such as transcranial magnetic stimulation (TMS), can have side effects including headaches, scalp discomfort at the stimulation site, and lightheadedness. Infrequent but more severe side effects may include seizures. Other common treatments like antidepressants can cause nausea, weight gain, sexual dysfunction, and insomnia. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

The FDA has approved several neuromodulation techniques for the treatment of depression, particularly for patients who do not respond to traditional antidepressants. Transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS), is one such treatment that has received FDA approval. These devices target specific brain regions to modulate neural activity and alleviate depressive symptoms. Additionally, vagus nerve stimulation (VNS) has also been approved for treatment-resistant depression. These approvals highlight the growing acceptance of neuromodulation therapies in managing depression.

What other types of research exist?

Promising alternatives to Mixed Reality Device for TMS targeting in depression treatment include neuronavigation systems and adaptive devices. Neuronavigation systems, although currently underutilized due to setup complexity, have shown improved treatment outcomes compared to traditional scalp measurements. Additionally, advancements in noninvasive neuromodulation devices, such as those using transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), are also promising. These technologies aim to enhance precision and reduce the burden on operators, making them viable options for 2024.

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Device

TMS Targeting Methods for Depression (XRnav Trial)

N/A

Waitlist Available

Led By Jennifer A McNab, PhD

Research Sponsored by Stanford University

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 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special headset that combines real and virtual elements to help doctors place a magnetic coil on the head more accurately during TMS treatment for depression. The goal is to see if this method improves treatment outcomes compared to traditional methods. Transcranial magnetic stimulation (TMS) is a relatively new technique used to treat depression by delivering magnetic radiation to the head using a hand-held coil.

Who is the study for?

This trial is for adults aged 18-75 with treatment-resistant depression who are prescribed transcranial magnetic stimulation (TMS) therapy. They must be MRI-compatible, meaning no metal in the body and able to complete screening at specific centers. Excluded are those with neurological disorders, pacemakers or certain implants, and a history of substance abuse.

What is being tested?

The study tests if using mixed reality devices can improve TMS targeting for treating depression compared to traditional scalp measurements or commercial neuronavigation systems. It aims to see if this method reduces setup time and is practical in clinical settings.

What are the potential side effects?

While not explicitly stated here, common side effects of TMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with response to TMS

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: No neuronavigationActive Control1 Intervention

For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via scalp measurements.

Group II: Mixed reality neuronavigationActive Control2 Interventions

For this group, the stimulation location for repetitive transcranial stimulation treatment is estimated by the clinician via a mixed reality neuronavigation device.

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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 the dorsolateral prefrontal cortex, which is often underactive in depression. This stimulation helps to normalize brain activity and improve mood. Understanding these mechanisms is crucial for depression patients as it emphasizes the importance of targeting specific brain regions to achieve therapeutic effects, potentially leading to more effective and personalized treatment options.