Cortical rTMS as a Treatment for Depression

Launched by BAYLOR COLLEGE OF MEDICINE · Aug 2, 2022

Keywords

ClinConnect Summary

This trial is testing whether a non-drug treatment called repetitive transcranial magnetic stimulation (rTMS), applied to a brain area called the orbitofrontal cortex, can help adults with Major Depressive Disorder (MDD). About 50 adults with MDD will receive up to 20 sessions of active rTMS over four weeks. Researchers will use MRI brain scans to look at how connections in the orbitofrontal area change during treatment and whether those brain changes relate to changes in depression symptoms. This is a single-group study, so there is no comparison group in this trial.

Eligible participants are adults aged 18–60 years with MDD who have depressive symptoms on standard screening tools and can give informed consent. They must not have safety risks that would make MRI or TMS unsafe (for example certain metal in the body, pregnancy, or inability to complete procedures). The study is located at The Menninger Clinic in Houston, TX, and is currently enrolling by invitation, aiming to enroll about 50 people. It is a device-based study overseen by a data safety monitoring committee, sponsored by Baylor College of Medicine and led by Hyuntaek Oh, PhD. If you enroll, you’ll undergo 20 rTMS sessions over about four weeks and MRI scans to track brain changes, with details about possible risks and benefits given by the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Be male or female aged 18-60 years old
• • Meets MDD criteria
• • Has depressive symptoms according to the Patients Health Questionnaire (PHQ)-9 or Hamilton Depression Rating Scale (HDRS) or Snaith-Hamilton Pleasure Scale (SHAPS)
• • Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
• • Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment
• • Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre- screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI)
• • Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.); Meets the pre-screening TMS safety questionnaire (Transcranial Magnetic Stimulation Adult Safety Screen - TASS)
• Exclusion Criteria:
• • In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS
• • Unable to understand the design and requirements of the study
• • Unable to sign informed consent for any reason
• • Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency
• • Female subjects who are pregnant or nursing
• • Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM
• • Contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.): Do not meet the pre-screening TMS safety questionnaire (TASS). Additional exclusion criteria for the TMS experiments are based on the recommendations described by the international consensus panel on brain stimulation.
• • Non-English speaking subjects (we do not have the staff and/or resources to include other language).