Connectomic Targeted TMS Target for Refractory Anxiety

NCT06376877 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024P000900
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Disorders; Mental Disorder; Psychiatric Disorder

Keywords

Transcranial Magnetic Stimulation; accelerated intermittent theta burst stimulation; theta burst stimulation; brain stimulation; neuromodulation; anxiety; transcranial; TMS; neuronavigation; neuroimaging

Outcome Measures

Primary Outcomes (1)

• Beck Anxiety Inventory (BAI)

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

  One week and one month after treatment

Secondary Outcomes (11)

• Inventory of Depression and Anxiety Symptoms-II

  One week and one month after treatment

• Hierarchical Taxonomy of Psychopathology (HiTOP)-Self Report, Distress, Fear, and Mania subfactors

  One week and one month after treatment

• State-Trait Anxiety Inventory

  One week and one month after treatment

• Penn State Worry Questionnaire (PSWQ)

  One week and one month after treatment

• Mood/Anxiety Symptoms Questionnaire: Anxious Arousal (MASQ:AA)

  One week and one month after treatment

Study Arms (2)

Real aiTBS

ACTIVE COMPARATOR

Participants in this group will receive aiTBS with neuronavigation to the anxiosomatic treatment target.

Procedure: Transcranial magnetic stimulation

Sham aiTBS

SHAM COMPARATOR

Participants in this group will receive sham aiTBS with neuronavigation to the anxiosomatic treatment target.

Procedure: Sham transcranial magnetic stimulation

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.

Real aiTBS

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.

Sham aiTBS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Emma Jones

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Mental Disorders

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Shan Siddiqi, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Jones

CONTACT

617-525-3536; bwhtmsanxiety@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: Nonresponders may have the option for open label active treatment.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 19, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

US (1)