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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Apr 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a treatment called Transcranial Magnetic Stimulation (TMS) for various mental health conditions, including major depressive disorder, obsessive-compulsive disorder, and schizophrenia. TMS uses magnetic fields to stimulate specific areas of the brain, and in this study, participants will receive TMS at different locations in the left side of the brain to see how it affects their behavior. The goal is to understand which brain circuits are most helpful in treating these mental health issues.

To participate, individuals must be between 18 and 65 years old and have a primary diagnosis of one of the specified conditions. They should also have stable medication for at least four weeks before starting the trial, or be off medication altogether. During the study, participants will undergo various behavioral tests to evaluate how TMS impacts their symptoms. It’s important to note that certain individuals, such as those who are pregnant or have specific severe mental health conditions, will not be eligible for this trial. This study is currently recruiting participants, and those who join can expect close monitoring and support from mental health professionals throughout the process.

Gender

ALL

Eligibility 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