Connectomic Targeted TMS Target for Refractory Anxiety

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06376877
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anxiety Disorders
  • Mental Disorder
  • Psychiatric Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial magnetic stimulation — PROCEDURE
    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.
  • Sham transcranial magnetic stimulation — PROCEDURE
    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.

Study Details

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 Dates

Start date
Aug 1, 2024
Status verified
Apr 2024
Primary completion
Aug 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Real aiTBS
    Participants in this group will receive aiTBS with neuronavigation to the anxiosomatic treatment target.
  • Sham Comparator: Sham aiTBS
    Participants in this group will receive sham aiTBS with neuronavigation to the anxiosomatic treatment target.

Primary Outcome Measure

Beck Anxiety Inventory (BAI) [ Time Frame: One week and one month after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emma JonesBostonMassachusetts02115

Find similar trials in Boston, MA

By research site
Emma Jones· Boston, MA

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