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Connectomic Targeted TMS for Refractory Anxiety

This study is testing a new way to use Transcranial Magnetic Stimulation (TMS) to treat anxiety disorders. TMS is a non-invasive procedure that uses magnetic fields to stimulate specific areas of the brain. In this study, a specific type of TMS called accelerated intermittent theta burst stimulation (aiTBS) will be used. Researchers want to see if this new approach is effective for people with anxiety disorders like Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Posttraumatic Stress Disorder, or Obsessive Compulsive Disorder, who have moderate anxiety and have not found relief from one previous treatment. The main goal is to see if participants' anxiety levels, measured by the Beck Anxiety Inventory (BAI), improve one week and one month after treatment.

Study design
This is a double-blinded, randomized study with 80 participants. Some participants will receive active TMS, while others will receive a sham (inactive) TMS.
What's involved
Participants will receive 50 active or sham TMS treatments over 5 days. Anxiety levels will be measured one week and one month after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants' anxiety levels will be checked one week and one month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06376877

Connectomic Targeted TMS Target for Refractory Anxiety

Not Yet Recruiting
PHASE2Ages 18–70InterventionalTreatment
Brigham and Women's Hospital
~80 participants
Updated 2024-04-19 on ClinicalTrials.gov
What's tested:Transcranial magnetic stimulationSham transcranial magnetic stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Beck Anxiety Inventory (BAI)
Measured over One week and one month after treatment

Conditions

Anxiety Disorders
Mental Disorder
Psychiatric Disorder

Explore related trials

Generalized Anxiety DisorderObsessive Compulsive DisorderPanic DisorderPost-Traumatic Stress DisorderSocial Anxiety Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Shan Siddiqi, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Emma Jones
[email protected]
617-525-3536
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
Diagnosis of one of the following anxiety-related disorders per Quick-SCID:
Generalized Anxiety Disorder
Social Anxiety Disorder
Panic Disorder
Posttraumatic Stress Disorder
Obsessive Compulsive Disorder
Moderate level of anxiety (BAI \>16)
One failed psychological or pharmacological treatment
Stable psychiatric medication regimen for 4 weeks prior to treatment and throughout treatment
Primary clinician (e.g. psychiatrist, psychologist, therapist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
Agreement to abstaining from becoming pregnant from screening to two weeks after treatment (the MRI visit)

Exclusion

• Active pregnancy as determined by a urine pregnancy test
Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
History of:
Exposure to TMS within the last 3 months
Neurosurgical intervention for psychiatric disorders
Autism spectrum disorder, intellectual disability, or cognitive impairment that impairs capacity to consent
Significant neurological illness deemed to increase risk from treatment
Moderate to severe neurodegenerative disease
Untreated or insufficiently treated endocrine disorder
Treatment with investigational drug or intervention during the study period
Bipolar I disorder or schizophrenia
Anyone presenting with:
Mania or hypomania
Psychosis
Active suicidal ideation with intent and a plan (defined by Columbia Suicide Severity Rating Scale)
Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.).
Current moderate or severe substance use disorder (excluding cannabis or nicotine) or demonstrating signs of acute substance withdrawal
Positive urine drug screen for illicit substances for cocaine, amphetamines, phencyclidine, and opioids, except for prescribed medications or known medications with history of resulting in a false positive
Existing tinnitus (ringing in the ears)
Any other condition deemed by the PI to interfere with the study or increase risk to the participant

What this trial measures

  • Beck Anxiety Inventory (BAI)One week and one month after treatment

    21 item self-report scale that assesses anxiety symptoms, with a particular emphasis on physiological anxiety symptoms