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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Transcranial magnetic stimulation

    Device

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: TMS to random PFC location 1Experimental treatment 1 intervention
Group B: TMS to random PFC location 2Experimental treatment 1 intervention
Group C: TMS to Schizophrenia locationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clustering of multiple behavioral measures

The primary outcome is that stimulation of different circuits will selectively modify different behavioral clusters. Participants will complete the following phenotyping battery tasks and questionnaires: Q-SCID PANSS SAPS SANS PYRATS CDSS YBOCS CGI ATQ ASI BAI BDI BIS/BAS Claremont Purpose Scale De Jong Gierveld Loneliness Scale Daily Spiritual Experience Scale Emotional Reactivity Scale Flourishing Measures Headache Impact Test HiTOP-Self Report Moral Judgment Scale Pain Screener Personal Relationship with God Scale PSQI Positive and Negative Affect Scale Ruminative Response Scale Self Compassion-Short Form Spiritual Transcendence Scale- Short Form Temporal Experience of Pleasure Scale Values and Beliefs of the American Public Altruistic Decision Task Balloon Analogue Risk Task DSIAT EEfRT MSIT ECR Time perception task TMB toolkit 5min AV recording

Time frame
through study completion, average of 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Harvard Medical School (HMS and HSDM)

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator