A Phase 2 interventional study of Transcranial magnetic stimulation and Sham transcranial magnetic stimulation in Anxiety Disorders, Mental Disorder and Psychiatric Disorder, sponsored by Brigham and Women's Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension.
We recently derived a novel TMS target for anxiety via lesion and brain stimulation mapping methods. We prospectively tested this target in a sample of participants with major depressive disorder (MDD) with comorbid anxiety symptoms and found that it was more effective for anxiety (median change 60.0% vs 39.8%, p=0.01) than the conventional TMS target for MDD with comorbid anxiety. While these results are promising, it remains unclear how our target works for anxiety-related disorders as opposed to MDD comorbid anxiety symptoms. Furthermore, we used conventional 10 Hz TMS, but accelerated intermittent theta burst stimulation (aiTBS) has now been shown to improve outcomes and is now an FDA approved treatment protocol. Finally, we tested the translational hypothesis that stimulating different circuits can modify different behaviors; clinical efficacy was a secondary outcome.
This double-blinded, randomized, sham-controlled aiTBS trial will test the efficacy of our novel anxiety target. 80 participants with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder) will receive 50 active or sham TMS treatments over 5 days. Changes in anxiety symptoms/processes will be assessed via validated measures (primary outcome measure: Beck Anxiety Inventory) during treatment and follow-up visits up to one-year post-treatment. Participants randomized to sham who do not respond will be offered an open-label crossover extension.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of one of the following anxiety-related disorders per Quick-SCID:
Exclusion Criteria:
Active pregnancy as determined by a urine pregnancy test
History of:
Anyone presenting with:
Participants in this group will receive aiTBS with neuronavigation to the anxiosomatic treatment target.
Procedure: Transcranial magnetic stimulation
Participants in this group will receive sham aiTBS with neuronavigation to the anxiosomatic treatment target.
Procedure: Sham transcranial magnetic stimulation
Transcranial magnetic stimulation (TMS) is a focal, non-invasive form of brain stimulation that has FDA clearance for depression. In this study, a form of TMS called accelerated intermittent theta burst stimulation will be administered under the supervision of a physician with TMS expertise.
The sham TMS coil mimics the scalp sensation of real TMS by delivering a small amount of electrical current with a pair of surface electrodes.
Beck Anxiety Inventory (BAI)
21 item self-report scale that assesses anxiety symptoms, with a particular emphasis on physiological anxiety symptoms
Time frame: One week and one month after treatment
Inventory of Depression and Anxiety Symptoms-II
99 item self-report scale of mood (e.g. dysphoria, suicidality, mania) and anxiety (e.g. social anxiety, panic, checking/ordering, traumatic avoidance/intrusion)
Time frame: One week and one month after treatment
Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors
HiTOP is a psychiatric nosology that organizes dimensional constructs across multiple levels of abstraction (from broad spectra to specific symptoms). The HiTOP-self report Distress, Fear, and Mania subfactors contain 117 items that capture a broad range of specific mood and anxiety-relevant symptoms
Time frame: One week and one month after treatment
State-Trait Anxiety Inventory
40 item self-report scale of present anxiety (i.e., state anxiety) and the general tendency toward anxiety
Time frame: One week and one month after treatment
Penn State Worry Questionnaire (PSWQ)
16 item self-report scale of trait worry and anxious apprehension, a transdiagnostic construct characterized by a persistent pattern of negative future thinking
Time frame: One week and one month after treatment
Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA)
90 item self-report with a 17 item scale that measures anxious arousal, a transdiagnostic construct characterized by a persistent pattern of hyperarousal/hypervigilance
Time frame: One week and one month after treatment
Anxiety Sensitivity Index (ASI)
16 item self-report scale of concern about anxious cognitions/physiological sensations
Time frame: One week and one month after treatment
Intolerance of Uncertainty Scale (IUS)
27 item self-report scale that measures cognitive, emotional, and behavioral reactions to the potential occurrence and unpredictability of negative future events
Time frame: One week and one month after treatment
Beck Depression Inventory (BDI)
21 item self-report scale that assesses depression symptoms
Time frame: One week and one month after treatment
TCI-R140 (Temperament and character inventory, revised 140-question format)
Psychobiologically-based personality inventory which measures seven personality dimensions (harm avoidance, novelty seeking, reward dependence, persistence, self-directedness, cooperativeness, and persistence). For each dimension, this yields a scaled T-score (mean score of 50 with standard deviation of 10). This is an overall estimate of personality traits, and there are no "better" or "worse" traits.
Time frame: One week and one month after treatment
Emotional Conflict Resolution Task
Computer task measuring accuracy and reaction time
Time frame: One week after treatment
Laboratory Fear Extinction Paradigm
We will use a validated fear extinction task (24) to assess the effects of anxiosomatic circuit TMS on fear discrimination and fear extinction. This task will consist of two learning phases: fear conditioning and fear extinction. We will measure fear via the skin conductance response.
Time frame: One week after treatment
Start is estimated for Aug 2024; primary completion for Aug 2028, 48 months later.
Of 65 non-industry phase 2 interventional studies under Anxiety Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 48 months is above that.
Counting every sponsor, half of 81 studies reached it within 34 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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