Recruiting
Phase 2

TMS

Sponsor:

Brigham and Women's Hospital

Code:

NCT06376734

Conditions

Major Depressive Disorder

Obsessive-Compulsive Disorder

Schizophrenia

Generalized Anxiety Disorder

Mood Disorders

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Transcranial magnetic stimulation

Study Details

Brief summary:

Participants will receive Transcranial Magnetic Stimulation (TMS) at a random location in the left prefrontal cortex, excluding sites that are potentially unsafe. Extensive behavioral testing will be conducted to determine which behaviors are modulated by stimulating which circuits.

Conditions

Major Depressive Disorder

Obsessive-Compulsive Disorder

Schizophrenia

Generalized Anxiety Disorder

Mood Disorders

Study ID

NCT06376734

Start date

Jan 30, 2025

Status verified date

Feb, 2026

Completion date

Jun 1, 2030

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18-65
  • English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
  • Primary diagnosis of one of the following: major depressive disorder (MDD), obsessive-compulsive disorder (OCD), generalized anxiety disorder (GAD), or schizophrenia (determined by focal assessment using the Structured Clinical Interview for DSM-5)

  • ≥20 on the Beck Depression Inventory for patients with MDD
  • ≥16 on the Beck Anxiety Inventory for patients with GAD
  • ≥16 on the Yale-Brown Obsessive-Compulsive Scale for patients with OCD
  • ≥58 on the Positive and Negative Symptom Scale for patients with schizophrenia
  • Stable psychotropic medication regimen, or remain medication free, for 4 weeks prior to treatment (Medication changes during study enrollment period will be tracked for post hoc analysis).
  • Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial

Exclusion Criteria:

  • Active pregnancy as determined by a urine pregnancy test
  • Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, narcissistic personality disorder)
  • PTSD with active, clinically significant symptoms, as determined by clinician
  • Diagnosis of Schizoaffective Disorder, Bipolar Type
  • Recent (within 4 weeks) or concurrent use of rapid-acting antidepressant agent (ketamine/esketamine/ECT)
  • Ferromagnetic metallic implant that would contraindicate receiving TMS or obtaining MRI
  • Any other TMS or MRI safety concerns identified by the clinician
  • Receiving or planning to receive other TMS treatments during course of participation
  • History of:

  • Neurosurgical intervention for mental illness
  • Moderate to severe autism spectrum disorder
  • Intellectual disability
  • Severe cognitive impairment
  • Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis)
  • Untreated or insufficiently treated endocrine disorder
  • Eating disorders
  • Treatment with investigational drug or intervention during the study period
  • Current evidence of:

  • Mania or hypomania
  • Active suicidal ideation or a suicide attempt within the past year
  • Contraindications to either TMS or MRI (e.g., metallic implants, etc.).
  • Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal
  • Significantly increased seizure risk as determined by a clinician
  • For participants with schizophrenia:

  • Evidence of impaired capacity to consent, e.g. impaired insight into illness, as deemed by a licensed psychiatrist or psychologist on the study team
  • Hospitalization with psychosis in the past 6 months
  • Positive urine drug screen for illicit substances
  • Existing tinnitus (ringing in the ears)
  • Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: TMS to random PFC location 1

Participants will receive 2 days of accelerated TMS (10 treatments per day) to a random location in the prefrontal cortex.

experimental: TMS to random PFC location 2

After a 2-month washout following arm 1, participants will receive another two days of accelerated iTBS treatment at a different random PFC location.

experimental: TMS to Schizophrenia location

Patients with schizophrenia will be offered to participate in a third arm of the trial, during which participants will receive 2 days of accelerated iTBS to a schizophrenia-specific target.

Interventions

Transcranial magnetic stimulation

Accelerated TMS will be provided for 2 days using the same dosing regimen as the FDA-cleared SAINT protocol, ten 9-minute treatments per day.

Primary outcome measure

  • Clustering of multiple behavioral measures [ Time Frame: through study completion, average of 3 months ]

Central Contacts and Locations

Central contacts

Emily Aquadro, MD

857-307-0294expedition@mgb.org

Locations

Acacia Clinics

Recruiting

Sunnyvale, California, United States, 94087

Contacts

Danielle DeSouza, PhD

857-307-0294expedition@mgb.org

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Jul 16, 2026

Last verified

Feb, 2026

Keywords

  • depression
  • anxiety
  • schizophrenia
  • OCD
  • obsessive-compulsive disorder
  • transcranial magnetic stimulation
  • TMS
  • accelerated TMS
  • accelerated intermittent theta burst stimulation
  • brain stimulation
  • neuromodulation
  • transdiagnostic
  • neuronavigation
  • functional connectivity
  • neuroimaging
  • theta burst stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-07-16.