Testing a Transdiagnostic TMS Treatment Target

Completed · Early Phase 1

Conditions studied: Major Depressive Disorder, Depression, Psychiatric Disorder, Mood Disorders, Mental Disorder, Anxiety Disorders, OCD, PTSD

In brief

The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function.

Key facts

Study ID

NCT06282146

Run by

Brigham and Women's Hospital

People needed

10

Starts

2024-09-09

Expected to finish

2026-06-06

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-65
• English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
• Diagnosis of MDD per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders) and currently experiencing a moderate to severe episode:
• >20 on Beck Depression Inventory (BDI)
• >20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) 14, 15
• Moderate to severe level of treatment resistance (Maudsley Staging Method)16, 17
• Diagnosis of at least one or more of the following psychiatric conditions per DSM-5 criteria (Quick Structured Clinical Interview for DSM-5 Disorders):
• Generalized anxiety disorder (GAD), panic disorder (PD), or social anxiety disorder (SAD)
• Obsessive compulsive disorder (OCD)
• Post-traumatic stress disorder (PTSD)
• Physician referral for individuals with either schizophrenia or schizoaffective disorder
• Stable psychiatric medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the two-week post-treatment visit
• Primary clinician (e.g. psychiatrist, therapist, psychologist, APRN, PA, etc.) responsible for psychiatric care before, during, and after the trial
• Agreement to lifestyle considerations
• Abstain from becoming pregnant from time of screening to two weeks after treatment (post-treatment MRI visit)
• Continue usual intake patterns of caffeine- or xanthine-containing products (e.g. coffee, tea, soft drinks, chocolate) throughout treatment
• Abstain from alcohol, tobacco, and recreational drugs for at least 24 hours before the start of each MRI and each TMS session

You may not qualify if…

• Active pregnancy as determined by a urine pregnancy test
• Positive urine drug screen for illicit substances (not including THC)
• Depressive symptoms refractory to 8 sessions of electroconvulsive therapy (ECT)
• Recent (within 4 weeks) or concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
• Receiving or planning to receive other TMS treatments during course of participation
• History of
• Autism spectrum disorder
• Neurosurgical intervention for depression
• Intellectual disability
• Severe cognitive impairment
• Significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion)
• Untreated or insufficiently treated endocrine disorder
• Treatment with investigational drug or intervention during the study period
• Depth-adjusted TMS treatment dose > 65% maximum stimulator output
• Existing tinnitus (ringing in the ears)
• Current evidence of:
• Mania or hypomania
• Active suicidal ideation or a suicide attempt (defined by C-SSRS) within the past year
• Neurological lesion
• Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia > 4 hours per night with hypnotic, etc.).
• Moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal (not including cannabis or nicotine use disorders)
• Bipolar I disorder
• For participants with schizophrenia or schizoaffective disorder referred by a physician:
• Total PANSS score >90
• Score >4 (moderate-severe) on any positive PANSS item

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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