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Mechanisms Of Orbitofrontal Stimulation in Depression

Mechanisms Of Orbitofrontal Stimulation in Depression (MOOD)

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 65 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 transcranial magnetic stimulation (TMS) can improve depression by changing activity in a brain area that helps manage emotions. TMS uses a coil near the scalp to send magnetic fields into the brain without surgery. The study is for adults ages 18–65 with moderate to severe major depression.

The orbitofrontal cortex (OFC), a region involved in emotional regulation, decision making, and reward processing, is a key area linked to antidepressant response. This study tests whether noninvasive stimulation of the OFC using transcranial magnetic stimulation (TMS) can improve depressive symptoms. TMS uses magnetic fields generated by a coil placed next to the scalp to alter brain activity.

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

Eligibility

Who can join

  • You are 18–65 years old.
  • You can read, speak, and understand English.
  • You have a diagnosis of major depression and currently have moderate to severe symptoms, with a score of at least 17 on the study’s depression rating scale.
  • Study staff believe you can complete the study tasks.
  • You are in stable treatment outside a hospital, with no hospital stays or medication changes in the past 30 days.

Who can't join

  • You have had a moderate to severe substance use disorder in the past 3 months, based on a study interview.
  • You have had fainting spells with an unknown cause that might have been seizures.
  • You have epilepsy, a condition that causes seizures. A single seizure with a harmless cause, such as fever, may be allowed if a qualified nerve and brain doctor approves.
  • You have or have had a nerve or brain disorder, such as a stroke, a disease that gets worse over time, or damaged areas in the brain. Past brain surgery or a head injury that left lasting nerve or brain problems also rules you out.
  • You have a medical condition that is not stable.
  • You have metal in your brain or skull, other than dental fillings, unless the study doctor approves.
  • You have a device that TMS or an MRI scan could affect, unless the study doctor approves. Examples include a pacemaker, medicine pump, nerve stimulator, hearing implant, electrical pain-control device, or tube that drains fluid from the brain.
  • You are pregnant. All female participants must take a pregnancy test.

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

Official eligibility criteria

Inclusion Criteria: * Age 18-65 years * Must be able to read, speak and understand English * DSM-5 diagnosis of major depressive disorder, experiencing a moderate to severe depressive episode (Hamilton Depression Rating Scale score greater than or equal to 17 points) * Must be judged by study staff to be capable of completing the study procedures * Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens Exclusion Criteria: * DSM-5 moderate to severe substance use disorder within the past three months, based on Structured Clinical Interview for DSM-5 * Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including: * History of fainting spells of unknown or undetermined etiology that might constitute seizures * Diagnosis of epilepsy with the exception of a single seizure of benign etiology (e.g., febrile seizures) in the judgment of a board-certified neurologist * Current or past history of a neurological disorder, such as stroke, a progressive neurologic disease, or intracranial brain lesion(s); and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment * Any unstable medical condition * Any metal in the brain or skull (excluding dental fillings) unless cleared by the responsible covering MD * Any devices which could be affected by TMS or MRI such as a pacemaker, medication pump, nerve stimulator, cochlear implant, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD * Pregnancy; All female participants will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study. The pregnancy test will be administered by study staff trained to administer point of care pregnancy testing that complies with institutional laboratory policies

Study sites (1)

MA