Cortical rTMS for Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will apply repetitive TMS to the orbitofrontal cortex while using interleaved fMRI to observe brain circuit changes over time. The goal is to understand how stimulation affects neural networks involved in reward, mood, addiction, and suicide risk, and how these changes correlate with symptoms. Participants are adults with depressive symptoms, some with opioid use disorder, and will undergo brain imaging and TMS sessions to monitor safety and potential improvements. The study emphasizes a longitudinal approach to link functional brain connectivity with clinical outcomes. Safety screening and medication stability are required prior to enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be male or female aged 18-64 years old.
2. Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS
3. Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
4. Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment
5. 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)
6. 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)
7. stabilized with medication treatments (e.g., methadone or buprenorphine) or abstinent from opioids if patients are seeking transition to naltrexone
8. urine toxicity test is negative for specific drugs (e.g., opioids)

Exclusion Criteria:

1. 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
2. Unable to understand the design and requirements of the study;
3. Unable to sign informed consent for any reason
4. Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency
5. Female subjects who are pregnant or nursing
6. 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
7. 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
8. Non-English speaking subjects (we do not have the staff and/or resources to include other languages);
9. Unstable with medication treatments (e.g., methadone or buprenorphine)
10. urine toxicity test is positive for specific drugs (e.g., opioids)
11. currently on seizure medications (e.g., Depakote)

Where it's running

• The Menninger Clinic
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Hyuntaek Oh, PhD
• Email: hoh@menninger.edu
• Phone: 713-275-5019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.