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NCT06282146CompletedEarly phase 1

Testing a Transdiagnostic TMS Treatment Target

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
10 (actual)
First submitted
6 Feb 2024
Start date
9 Sept 2024
Primary completion date
23 May 2025
Lead sponsor
Brigham and Women's Hospital
Diseases
Depression
NCT number
NCT06282146

What you commit to

  • Study type: Interventional · Early phase 1
  • Participants enrolled: 10
  • From 9 Sept 2024 to the primary completion date, 23 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Treatment with investigational drug or intervention during the study period
  • Contraindications to either TMS or MRI (e.g., metallic implants, severe insomnia \> 4 hours per night with hypnotic, etc.).

Other illness

  • History of
  • Autism spectrum disorder
  • 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
  • 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:
  • Active substance use disorder (other than nicotine)
  • Severe borderline personality disorder
  • Any other condition deemed by the PI to interfere with the study or increase risk to the participant

Other

  • Active pregnancy as determined by a urine pregnancy test
  • Neurosurgical intervention for depression
  • Intellectual disability
  • 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
  • Total PANSS score \>90
  • Score \>4 (moderate-severe) on any positive PANSS item
  • Hospitalization for psychosis in the past 6 months

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Brigham and Women's Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.