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Cortical rTMS as a Treatment for Depression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether repeated magnetic pulses to a brain area called the orbitofrontal cortex can reduce depression symptoms. This treatment, called rTMS, stimulates the brain without surgery. The study is for adults ages 18–64 who have depression symptoms.

Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–64 years old.
  • Have depression symptoms based on study questionnaires.
  • Be able to explain your understanding of the consent form, sign it, and agree to complete study steps.
  • Not be pregnant or breastfeeding during brain scans and TMS treatment.
  • Pass MRI brain scan safety checks. Pacemakers, hearing implants, or metal in the body may make scans unsafe.
  • Pass TMS safety checks. Metal that cannot be removed from the head, except the mouth, or within 12 inches of the magnetic coil may be unsafe.
  • Be stable on medicines such as methadone or buprenorphine, or be off opioids if seeking to switch to naltrexone.
  • Have a urine test that is negative for certain drugs, such as opioids.

Who can't join

  • The study team expects you cannot finish the study because you cannot tolerate TMS.
  • You cannot understand the study or sign the consent form.
  • You have an unstable medical condition, such as AIDS, sudden liver inflammation, active tuberculosis, unstable heart disease or diabetes, or poor liver or kidney function.
  • You are pregnant or breastfeeding.
  • You do not pass MRI or TMS safety checks, including checks for unsafe metal or implants and other brain stimulation safety rules.
  • You do not speak English.
  • You are not stable on medicines such as methadone or buprenorphine, or your urine test is positive for certain drugs, such as opioids.
  • You currently take seizure medicines, such as Depakote.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

TX