rTMS for Anxiety Disorders
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Anticholinergics, Neuroleptics, Sedatives, Opiates
Disqualifiers: Substance use disorder, Psychotic disorder, Neurological disorder, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking anticholinergic, neuroleptic, sedative/hypnotic, chronic opiate medications, or naltrexone. However, you can continue taking SSRIs, cholinesterase inhibitors, or NMDA receptor antagonists if you've been on a stable dose for at least four weeks before joining the study.
What data supports the effectiveness of the treatment rTMS for anxiety disorders?
Research shows that repetitive transcranial magnetic stimulation (rTMS) can reduce anxiety and stress levels, as seen in studies where it decreased anxiety in patients with depression and reduced physiological arousal related to fear and anxiety. These findings suggest that rTMS may help manage anxiety disorders by calming overactive brain areas linked to anxiety.12345
Is rTMS safe for humans?
Repetitive transcranial magnetic stimulation (rTMS) is generally considered safe for humans, with studies showing it can reduce anxiety and stress in some cases. However, there are reports of rTMS inducing anxiety in some individuals, so it's important to discuss potential risks with a healthcare provider.12467
How does rTMS treatment for anxiety disorders differ from other treatments?
rTMS (repetitive transcranial magnetic stimulation) is unique because it is a non-invasive treatment that uses magnetic fields to modulate brain activity, specifically targeting areas like the intraparietal sulcus to reduce anxiety. Unlike traditional medications, it directly influences brain connectivity and excitability, offering a novel approach for those who may not respond well to neuropharmacological treatments.12358
Eligibility Criteria
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.Inclusion Criteria
Is currently seeking mental health treatment
I am between 18 and 65 years old.
I have been diagnosed with an anxiety disorder or PTSD.
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Exclusion Criteria
Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)
Lifetime diagnosis of psychotic disorder or bipolar mania
I do not have metal implants, am not pregnant, do not have claustrophobia, am not overly sensitive to noise, do not have a low seizure threshold, have never had a severe brain injury, and do not have a history of seizures or epilepsy.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete interviews, surveys, and tasks involving emotional pictures while brain activation is measured
1 day
1 visit (in-person)
Neurostimulation
Participants receive rTMS and complete tasks before and after stimulation
2 days
2 visits (in-person)
Follow-up
Participants are monitored for changes in anxiety-related measures post-stimulation
4 weeks
Treatment Details
Interventions
- Modulating Anxious Coping (Behavioural Intervention)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Low-frequency parietal repetitive transcranial magnetic stimulation reduces fear and anxiety. [2022]Anxiety disorders are the most prevalent mental disorders, with few effective neuropharmacological treatments, making treatments development critical. While noninvasive neuromodulation can successfully treat depression, few treatment targets have been identified specifically for anxiety disorders. Previously, we showed that shock threat increases excitability and connectivity of the intraparietal sulcus (IPS). Here we tested the hypothesis that inhibitory repetitive transcranial magnetic stimulation (rTMS) targeting this region would reduce induced anxiety. Subjects were exposed to neutral, predictable, and unpredictable shock threat, while receiving double-blinded, 1 Hz active or sham IPS rTMS. We used global brain connectivity and electric-field modelling to define the single-subject targets. We assessed subjective anxiety with online ratings and physiological arousal with the startle reflex. Startle stimuli (103 dB white noise) probed fear and anxiety during the predictable (fear-potentiated startle, FPS) and unpredictable (anxiety-potentiated startle, APS) conditions. Active rTMS reduced both FPS and APS relative to both the sham and no stimulation conditions. However, the online anxiety ratings showed no difference between the stimulation conditions. These results were not dependent on the laterality of the stimulation, or the subjects' perception of the stimulation (i.e. active vs. sham). Results suggest that reducing IPS excitability during shock threat is sufficient to reduce physiological arousal related to both fear and anxiety, and are consistent with our previous research showing hyperexcitability in this region during threat. By extension, these results suggest that 1 Hz parietal stimulation may be an effective treatment for clinical anxiety, warranting future work in anxiety patients.
Emotional processing and rTMS: does inhibitory theta burst stimulation affect the human startle reflex? [2018]Repetitive transcranial magnetic stimulation (rTMS) enables the local and non-invasive modulation of cortical activity and has proved to achieve antidepressant effects. To a lesser extent, rTMS is investigated as a treatment option for anxiety disorders. As the prefrontal cortex and the amygdala represent key components of human emotion regulation, we investigated how prefrontally applied rTMS affects the responsiveness of the subcortical amygdala during a fear-relevant study paradigm to examine potential cortico-limbic effects. Sham-controlled, randomised inhibitory rTMS (continuous theta burst stimulation, TBS) was applied to 102 healthy subjects (female = 54) over the right dorsolateral prefrontal cortex. Subsequently, the emotion-potentiated (unpleasant, neutral, and pleasant International Affective Picture System pictures) acoustic startle response was investigated. Subjective anxiety ratings (anxiety sensitivity, trait and state anxiety) were considered. Picture category affected the startle magnitude as expected for both TBS intervention groups (highest startle response for unpleasant, lowest for pleasant pictures). However, no modulatory effects of TBS on startle potentiation were discerned. No significant interaction effects of TBS intervention, subjective anxiety ratings, and gender were identified. Interestingly, startle habituation was influenced by TBS intervention on a trend-level, with verum TBS leading to an accelerated habituation. We found no evidence for the hypothesis that prefrontal inhibitory TBS affects the responsiveness of the amygdala during the presentation of emotionally relevant stimuli in healthy subjects. Instead, we found accelerated habituation under verum TBS on a statistical trend-level. Hence, some preliminary hints for modulatory effects of inhibitory TBS on basic learning mechanisms could be found.
Effects of slow rTMS at the right dorsolateral prefrontal cortex on EEG asymmetry and mood. [2019]In a sham-controlled design (n = 12), slow repetitive transcranial magnetic stimulation (rTMS) was applied to the right dorsolateral prefrontal cortex for 20 min, and the subsequent effects on mood and the EEG spectrum were investigated, Analysis revealed a significant left hemisphere increase in EEG theta activity at 25-35 and 55-65 min after stimulation. In addition, participants reported significant decrease in anxiety immediately after stimulation, as well as 35 and 65 min after rTMS. These findings indicate that reductions in anxiety after slow rTMS at the right dorsolateral prefrontal cortex are associated with a contralateral increase in theta activity.
Repetitive Transcranial Magnetic Stimulation: Influence on Stress and Early Responsiveness Outcomes for Depression, Anxiety, and Stress. [2022]The present study investigated whether rTMS treatment for depression reduced stress and whether early responsiveness of rTMS predicted outcomes for depression, anxiety, and stress at the conclusion of treatment. Participants (n = 109) were inpatients at a psychiatric hospital referred for rTMS for depression. Linear mixed models were used to analyse data across time and regression analyses were used to assess early responsiveness. Effect sizes, and clinically significant and reliable change were also analysed. Decreases in scores for depression, anxiety, and stress were evident from pre- to mid-treatment, and from mid- to post-treatment. Large effect sizes were reported from pre- to post-treatment for depression and stress. Changes in depression from pre- to mid-treatment predicted post-treatment depression and stress scores. Clinically significant change was most common for stress and reliable change was most common for depression. Standard rTMS treatment for depression appears to have non-specific benefits in that participant anxiety and stress ratings also improve significantly. Early improvements in depressive symptoms may be indicative of later depression and stress outcomes, suggesting clinical benefit in assessing outcomes during rTMS treatment.
Effect of low-frequency transcranial magnetic stimulation on an affective go/no-go task in patients with major depression: role of stimulation site and depression severity. [2008]Repetitive transcranial magnetic stimulation (rTMS) holds promise as a therapeutic tool in major depression. However, a means to assess the effects of a single rTMS session on mood to guide subsequent sessions would be desirable. The present study examined the effects of a single rTMS session on an affective go/no-go task known to measure emotional-cognitive deficits associated with major depression. Ten patients with an acute episode of unipolar major depression and eight partially or completely remitted (improved) patients underwent 1 Hz rTMS over the left and right dorsolateral prefrontal cortex prior to task performance. TMS over the mesial occipital cortex was used as a control. We observed significantly improved performance in depressed patients following right prefrontal rTMS. This beneficial effect declined with decreasing depression severity and tended to reverse in the improved group. Left prefrontal rTMS had no significant effect in the depressed group, but it resulted in impaired task performance in the improved group. Our findings indicate that the acute response of depressed patients to rTMS varies with the stimulation site and depression severity. Further studies are needed to determine whether the present paradigm could be used to predict antidepressant treatment success or to individualize stimulation parameters according to specific pathology.
Anxiolytic suppression of repetitive transcranial magnetic stimulation-induced anxiety in the rats. [2013]Repetitive transcranial magnetic stimulation (rTMS) is effective for treatment of several psychiatric disorders such as depression and anxiety disorder. However, some reports suggest that rTMS induced anxiety in normal volunteers. Consistent with this observation, we have reported that chronic rTMS induces anxiety in normal rats which was suppressed by chronic treatment, but not acute paroxetine treatment. The current study evaluates rTMS as animal model of anxiety by investigating the effect of rTMS on anxiety behaviors and the ability of standard anxiolytics to block expression of these behaviors. We found that 10-day rTMS induced anxiety in normal rats, as evidenced by expression of anxiety behaviors in the elevated plus-maze. This anxiety was suppressed by acute treatment with diazepam, alprazolam, or buspirone suggesting that chronic rTMS treatment provides a good animal model for anxiety.
Effect of repetitive transcranial magnetic stimulation on anxiety symptoms in patients with major depression: An analysis from the THREE-D trial. [2021]Despite the advances in the use of repetitive transcranial magnetic stimulation (rTMS) for the treatment of major depressive disorder (MDD), there is relatively little information about its effect on comorbid anxiety symptoms.
The Effects of Functionally Guided, Connectivity-Based rTMS on Amygdala Activation. [2021]While repetitive transcranial magnetic stimulation (rTMS) is widely used to treat psychiatric disorders, innovations are needed to improve its efficacy. An important limitation is that while psychiatric disorders are associated with fronto-limbic dysregulation, rTMS does not have sufficient depth penetration to modulate affected subcortical structures. Recent advances in task-related functional connectivity provide a means to better link superficial and deeper cortical sources with the possibility of increasing fronto-limbic modulation to induce stronger therapeutic effects. The objective of this pilot study was to test whether task-related, connectivity-based rTMS could modulate amygdala activation through its connectivity with the medial prefrontal cortex (mPFC). fMRI was collected to identify a node in the mPFC showing the strongest connectivity with the amygdala, as defined by psychophysiological interaction analysis. To promote Hebbian-like plasticity, and potentially stronger modulation, 5 Hz rTMS was applied while participants viewed frightening video-clips that engaged the fronto-limbic network. Significant increases in both the mPFC and amygdala were found for active rTMS compared to sham, offering promising preliminary evidence that functional connectivity-based targeting may provide a useful approach to treat network dysregulation. Further research is needed to better understand connectivity influences on rTMS effects to leverage this information to improve therapeutic applications.