Repetitive Transcranial Magnetic Stimulation (rTMS) for Anxiety Disorders

Phase-Based Estimates
1
Effectiveness
1
Safety
Medical University of South Carolina, Charleston, SC
Anxiety Disorders
Repetitive Transcranial Magnetic Stimulation (rTMS) - Device
Eligibility
18+
All Sexes
Eligible conditions
Anxiety Disorders

Study Summary

This study is evaluating whether a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Repetitive Transcranial Magnetic Stimulation (rTMS) will improve 2 primary outcomes, 7 secondary outcomes, and 1 other outcome in patients with Anxiety Disorders. Measurement will happen over the course of Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments).

During Session (Approx. 45 minutes)
Task-Related Brain Activation
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Approach/ Avoidance Conflict Electroencephalography
Change in Difficulty of Avoiding Task-Based Aversive Exposure
Change in Escape/ Avoidance Electroencephalography
Change in Fear-Potentiated Startle Reflex
Change in Speed to Initiate Avoidance Behavior
Change in State Anxiety During Session
Change in Task-Related Heart Rate Changes
Change in Task-Related Perceived Control
Change in Task-Related Skin Conductance Responding

Trial Safety

Trial Design

2 Treatment Groups

Control
Neurostimulation Group

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Repetitive Transcranial Magnetic Stimulation (rTMS) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Neurostimulation Group
Device
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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Repetitive Transcranial Magnetic Stimulation (rTMS)
2011
Completed Phase 2
~630

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during session (approx. 45 minutes)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during session (approx. 45 minutes) for reporting.

Who is running the study

Principal Investigator
C. S.
Christopher Sege, PhD
Medical University of South Carolina

Closest Location

Medical University of South Carolina - Charleston, SC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 - 65 y.o.
Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety
Is currently seeking mental health treatment
Is able to read consent document and provide informed consent.
English is a first or primary fluent language.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has repetitive transcranial magnetic stimulation (rtms) proven to be more effective than a placebo?

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Recent findings reported positive results of tDCS use in anxiety disorder, but not depression. The effectiveness of tDCS in anxiety is not yet verified. However, if proven, the use of tDCS in anxiety disorder may be an effective short-term treatment option.

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What are the signs of anxiety disorders?

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Anxiety symptoms include a sense of tension and worrying about physical sensations. They are usually accompanied by an increased level of arousal. There are a number of psychological tests that can help with differential diagnosis of anxiety disorders.

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What causes anxiety disorders?

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Anxiety may result from a biological imbalance, including neurotransmitter malfunction or genetic alterations. The biological basis of anxiety may in fact not be well understood, since it affects almost every organ on the body. It can also result from life situations, including negative experiences, and cognitive distortions. Anxiety symptoms are not universal, as they are also influenced through a person's personality. Anxiety is one of the most commonly overlooked health conditions.\n

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Can anxiety disorders be cured?

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Based on the positive results of a recently conducted double-blind randomized placebo-controlled study on treatment of panic disorder and its subtype agoraphobia with the anxiolytic drug alprazolam, we suggest that there may be a basis for the treatment of anxiety disorders.

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What is anxiety disorders?

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Anxiety disorders are a very common medical condition with both moderate and severe repercussions. Physicians should be alert to anxiety symptoms. Anxiety symptoms often represent a risk factor for anxiety disorders, such as panic attacks for which the most efficacious pharmacological treatments exist.

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How many people get anxiety disorders a year in the United States?

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Anxiety disorders (including specific phobias and specific post-traumatic stress disorders) are prevalent and disabling in the US population. The rate of diagnosis appears to continue. Anxiety disorders are associated with high rates of utilization of health care and psychotherapy. Many patients are dissatisfied with their treatment.

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What are common treatments for anxiety disorders?

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There are some treatments that may be used with people who have anxiety disorders. The first thing to consider with people with anxiety disorders is to help them learn skills to cope with anxiety so they can be better treated. It is also important to have treatments to help people overcome the anxiety. These are available as one-on-one sessions with a therapist. Cognitive behavioral therapy works in some cases where the problem is not bad enough to go to seeing a doctor, and the problem can be reduced or eliminated with help of the sessions of a therapist.

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How does repetitive transcranial magnetic stimulation (rtms) work?

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Although the mechanism is not clear, rtms over the left DLPFC appears to reduce the effects of anxiety and depression in individuals with major depression.

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What are the common side effects of repetitive transcranial magnetic stimulation (rtms)?

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We can conclude that rtms at a very low frequency is not associated with an increased risk of side effects compared with the placebo group. Although there were no adverse effects or problems in most of the reported side effects, the high percentage of patients who reported headache has been taken into account. The observed headache resolves after receiving the stimulation, and there is no need to treat this complaint after the stimulation is finished. Further studies in patients using rtms for long term treatment of chronic pain are awaited with more detail. Copyright © 2016 John Wiley & Sons, Ltd.

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What is the average age someone gets anxiety disorders?

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The lifetime prevalence of anxiety disorder is estimated to be 1.1-1.2% in the general U.S. population. About one in twelve adults (7%) had a lifetime diagnosis of anxiety disorder at some point in his or her life. Men and women differ in their lifetime rates of diagnosis: about one in six women (15%) had a lifetime diagnosis of an anxiety disorder.

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Does anxiety disorders run in families?

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In a recent study, findings are consistent with family environmental transmission of anxiety disorders. This implies an important role for both genetic and familial environmental risk factors, which contribute to the clinical and epidemiological differences between families.

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How serious can anxiety disorders be?

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Anxiety disorders are a common problem in primary care, but the problem may not always be treated in a consistent manner, which could potentially lead to patient dissatisfaction. This pilot study aims to examine some of these issues, and provide possible solutions for patients.

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