Individualized fMRI-guided TMS for Depression

Prior treatment

• Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
• Prior failed response to full rTMS or ECT/MST trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
• Current use of Bupropion (Wellbutrin) above 300 mg, benzodiazepines, lithium, monoamine oxidase inhibitors (MAOIs), and/or high doses of stimulant medication is exclusionary. Note: Exclusionary dosages or medications may be reduced or discontinued under the supervision of a medical provider. For detailed information please refer to section 5.3.1.
• Per study physician discretion medications likely to interfere with blood flow or otherwise compromise functional imaging measures.
• Refrain from substance use (including marijuana and illicit drugs) for the duration of the study (self-attestation alone)
• Inform the study team of any new medical treatments or prescribed medications (e.g., antibiotics) to allow for safety review and determination of continued eligibility for the study.
  • Participants who do not follow these considerations will be evaluated on a case-by-case basis. Principal Investigator will determine if study withdrawal is appropriate.

Other illness

• History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
• Current psychosis, mania, or substance use disorder
• Acute systemic infection, high fever
• Acute sleep deprivation or medication/substance intoxication or withdrawal (TMS seizure risk)
• Not initiate, discontinue, or adjust any psychiatric medications or therapy treatments during the study period.

Other

• Any individual who meets any of the following criteria at the time of enrollment will be excluded from participation:
• Inability to complete an MRI scan (e.g., claustrophobia, inability to remain still for extended periods).
• Inability to tolerate TMS administration
• Significant handicaps that would interfere with testing procedures
• Current use of cyclosporine, tacrolimus, or others that can cause leukoencephalopathy.
• Pregnancy
• Dialysis
• Suicide attempt in past 6 months (safety precaution); similarly, if ideation is particularly pronounced, Drs. Oathes and Sheline will decide with the patient whether the benefit of participating in a sham controlled (all patients given the option to receive active treatment eventually) study outweighs the risks. If the patient has a mental health provider and acquiesces, consultation with the provider will also be instrumental in this decision.
• Transportation limits or physical limits to attending daily M-F treatment sessions.
• Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from procedure site; unlikely to be able to schedule daily treatment sessions, etc.)
  • Study Participation Expectations
  • During this study, participants will be asked to:
• Abstain from alcohol for 24 hours before study visits (self-attestation alone)
• Maintain a consistent level of caffeine consumption throughout the study period and avoid any significant increases (self-attestation).

• In order to participate in this study, potential participants must meet all of the following eligibility criteria:
• 18-65 years old
• DSM-5 diagnosis of major depressive (at least 90%) or persistent depressive disorder (no more than 10%) as per SCID clinical interview.
• PHQ-9 score = or \> than 10 (to maintain minimal severity of symptoms in the MDD sample)
• Comprehension of instructions in the English language.
• Capacity to provide informed consent and follow study procedures.
• Availability for the duration of the study.