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Search / Trial NCT07043738

Imaging- vs. Scalp-Targeted Accelerated TMS for Depression: The Number Needed to Scan Trial

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jun 26, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Accelerated Transcranial Magnetic Stimulation Depression Major Depressive Disorder Treatment Resistant Depression Tms Transcranial Magnetic Stimulation Neuromodulation

ClinConnect Summary

This clinical trial is studying a treatment called accelerated transcranial magnetic stimulation (aTMS) for people with major depression. aTMS uses magnetic pulses to gently stimulate specific parts of the brain to help improve mood. Unlike traditional TMS, which is given once a day over several weeks, aTMS delivers multiple treatments each day over just five days. This study wants to find out whether using brain scans (MRI) to guide the treatment works better than the usual method of targeting the treatment based on measurements of the scalp. This is important because MRI-guided treatment might be more precise but is also more expensive and harder to access.

People who might be eligible for this study are adults between 22 and 80 years old who have moderate to severe depression that has not improved well with treatment so far. Participants need to be able to speak English well enough to understand and agree to the study, and must have stable antidepressant use or no medications for at least four weeks before starting. During the study, participants will receive multiple aTMS sessions each day for five days, with either MRI-based or scalp-based targeting, assigned randomly. They will be asked to avoid alcohol, tobacco, and recreational drugs before sessions and follow some lifestyle guidelines during the study. This trial is not yet recruiting but aims to help doctors understand the best way to deliver this promising depression treatment.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age 22-80
  • English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
  • Primary diagnosis of major depressive disorder per DSM-V criteria (Quick Structured Clinical Interview for DSM-5)
  • \>20 on Beck Depression Inventory (BDI)
  • \>20 on the Montgomery-Åsberg Depression Rating Scale (MADRS)
  • Moderate to severe level of treatment resistance (Maudsley Staging Method)
  • Stable antidepressant medication regimen, or remain medication free, for 4 weeks prior to treatment and to remain on this regimen throughout the study until the 1-month 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 screening to one-month after treatment (the 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 TMS session

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported