Exploring new brain stimulation targets for mental health conditions
Transdiagnostic Circuit Mapping of Prefrontal Targets in Accelerated Transcranial Magnetic Stimulation
This study is testing how a brain stimulation treatment can help people with depression, anxiety, OCD, and schizophrenia by looking at changes in their brain and behavior.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 2 sites (Sunnyvale, California and 1 other locations) |
| Trial ID | NCT06376734 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Transcranial Magnetic Stimulation (TMS) on patients with major depressive disorder, obsessive-compulsive disorder, generalized anxiety disorder, and schizophrenia. Participants will undergo TMS at two different sites in the left prefrontal cortex, with extensive behavioral testing and fMRI scans conducted before and after each treatment session. The study aims to identify which brain circuits are influenced by stimulation and how these changes relate to behavioral outcomes. All participants will receive active stimulation to ensure ethical treatment and facilitate enrollment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of major depressive disorder, obsessive-compulsive disorder, generalized anxiety disorder, or schizophrenia.
Not a fit: Patients with unstable psychiatric conditions or those not meeting the specific diagnostic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and targeted treatments for various mental health disorders.
How similar studies have performed: Previous studies using TMS have shown promising results in treating various mental health conditions, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sunnyvale, California and 1 other locations
- Acacia Clinics — Sunnyvale, California, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shan H Siddiqi, MD — Brigham and Women's
- Study coordinator: Emily Aquadro, MD
- Email: expedition@mgb.org
- Phone: 857-307-0294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.