RecruitingPhase 2NCT06376734

Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness

Transdiagnostic Circuit Mapping of Prefrontal Targets in Accelerated Transcranial Magnetic Stimulation

Sponsor

Brigham and Women's Hospital

Enrollment

180 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Depression, Anxiety Schizophrenia Psychiatric Disorder Major Depressive Disorder Obsessive-Compulsive Disorder Generalized Anxiety Disorder Mood Disorders Mental Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

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 Criteria29

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