๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-04-17

Connectomic Targeted TMS Target for Refractory Anxiety (NCT06376877)

๐ŸŸก Not Yet Recruiting Phase2 ๐Ÿฉบ Clinical Procedure Protocol Sponsor: Brigham and Women's Hospital

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (21 items).

Location: Emma Jones โ€” Boston, Massachusetts

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • โ€ข 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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Emma Jones โ€” Boston, Massachusetts

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—