Connectomic Targeted TMS Target for Refractory Anxiety

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Anxiety Disorders, Mental Disorder, Psychiatric Disorder

In brief

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.

Key facts

Study ID

NCT06376877

Run by

Brigham and Women's Hospital

People needed

80

Starts

2024-08-01

Expected to finish

2029-02-01

Last updated by the study team

2024-04-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• • 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

Where it is running

• Emma Jones — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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