What side effects are associated with this type of intervention?

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive treatment that temporarily increases brain activity in targeted areas and is being studied for its potential benefits in anxiety disorders. Known side effects of rTMS include mild headaches, scalp discomfort at the stimulation site, tingling, spasms, or twitching of facial muscles, and, in rare cases, seizures. Other common treatments for anxiety disorders, such as SSRIs, can cause side effects like nausea, insomnia, dizziness, and sexual dysfunction. Benzodiazepines, another class of medications, may lead to drowsiness, dependence, and cognitive impairment.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). While repetitive transcranial magnetic stimulation (rTMS) is being studied for its potential to modulate brain activity and improve anxiety symptoms, it is not yet FDA-approved specifically for anxiety disorders. However, rTMS is approved for treatment-resistant depression, which shares some overlapping symptoms with anxiety disorders. Other non-pharmacologic treatments for anxiety, such as cognitive-behavioral therapy (CBT), are also widely used.

What other types of research exist?

Promising, novel alternatives to rTMS for anxiety disorders include: 1) Noninvasive vagus nerve stimulation (nVNS), which has shown benefits in reducing symptoms of anxiety and depression. 2) Transcutaneous supraorbital nerve stimulation, which has demonstrated efficacy in reducing pain intensity in migraine patients and may have potential applications for anxiety. 3) Remote electrical neuromodulation (REN), which has been effective in treating acute migraine and could be explored for anxiety treatment. These alternatives offer non-invasive options that have shown promise in related conditions and may be considered for anxiety disorders.

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rTMS for Anxiety Disorders

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

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 during session (approx. 45 minutes)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a device called rTMS, which uses magnetic fields to stimulate the brain, can help people cope better with fear and anxiety. The magnetic field increases brain activity, which might improve their responses to anxiety-inducing situations. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain and has been explored for treating various psychiatric disorders, including depression and anxiety.

Who is the study for?

This trial is for adults aged 18-65 who are fluent in English, currently seeking mental health treatment, and diagnosed with an anxiety disorder or related condition. It's not suitable for those on certain medications, pregnant individuals, people with metal implants (due to MRI), history of seizures or severe brain injury, substance abuse issues, psychotic disorders or bipolar mania.

What is being tested?

The study tests if repetitive Transcranial Magnetic Stimulation (rTMS) can influence coping mechanisms in anxious situations. Participants will undergo rTMS and perform tasks that measure their reaction to emotional stimuli over three visits lasting up to four hours each at the Medical University of South Carolina.

What are the potential side effects?

While this study isn't a treatment trial and focuses on reactions to emotional stimuli post-rTMS application, potential side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during session (approx. 45 minutes)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during session (approx. 45 minutes)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during session (approx. 45 minutes) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Fear-Potentiated Startle Reflex

Change in Speed to Initiate Avoidance Behavior

Secondary study objectives

Change in Approach/ Avoidance Conflict Electroencephalography

Change in Difficulty of Avoiding Task-Based Aversive Exposure

Change in Escape/ Avoidance Electroencephalography

+4 more

Other study objectives

Task-Related Brain Activation

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: Neurostimulation GroupExperimental Treatment1 Intervention

On one study day, participants will complete experimental tasks during functional magnetic resonance imaging. On two other study days, participants will complete tasks before and after receiving repetitive transcranial magnetic stimulation (rTMS). All participants will receive rTMS to ventromedial prefrontal cortex on one study day, and to pre-supplementary motor area on another study day. Two stimulation procedures will be used, one for ventromedial prefrontal cortex and one for pre-supplementary motor area. For both targets, 3 sessions of 600 pulses at 110% of resting motor threshold will be presented over 30 minutes. For ventromedial cortex, a session will involve intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. For pre-supplementary motor area, a session will involve continuous theta burst presented in 3-pulse bursts with 15 pulses/ sec.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation (rTMS)

2019

Completed Phase 2

~780

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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

Repetitive Transcranial Magnetic Stimulation (rTMS) works by rapidly turning a focused magnetic field on and off over the head, which temporarily increases brain activity in targeted areas. This mechanism is significant for patients with anxiety disorders because it can modulate neural circuits involved in anxiety, potentially reducing symptoms. By directly influencing brain activity, rTMS offers a non-invasive alternative for patients who may not respond well to traditional treatments like medication or psychotherapy, providing a new avenue for symptom relief.