RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Transdiagnostic Circuit Mapping of Prefrontal Targets in Accelerated Transcranial Magnetic Stimulation

Quick Facts

Study Start:2025-01-30

Study Completion:2030-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06376734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Emily Aquadro, MD

CONTACT

857-307-0294

expedition@mgb.org

Principal Investigator

Shan H Siddiqi, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's

Study Locations (Sites)

Acacia Clinics

Sunnyvale, California, 94087

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Shan H Siddiqi, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-30

Study Completion Date2030-06-01

Study Record Updates