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EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression

Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder

Who can join

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

Age
22 Years to 60 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

  • Time periods mentioned: 6 weeks, 3 months
  • Procedures mentioned: MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Blinded clinical raters will collect depression symptom severity measures at screening, baseline, and weekly for 6 weeks followed by monthly follow-up visits for 3 months to assess for delayed responses to treatment."
  • "TBS treatment will be delivered once daily (5 days per week for 6 weeks) to the left DLPFC at 120% MT, 600 pulses per session."
  • "The Localite system will provide neuronavigation for treatment site localization with the participant's structural MRI or in patients that cannot obtain an MRI, the provided standard MNI atlas."
  • "Depressive symptom severity will be assessed weekly with the 17-item Hamilton Depression Rating Scale (HDRS), the Montgomery-Asberg Depression Rating Scale (MADRS), a patient-reported Patient Health Questionnaire (PHQ-9)55, and a Generalized Anxiety Disorder 7-time scale (GAD-7)56."
  • "Clinical assessments visits will take place during the last treatment day (treatment 5) of every week for 6 weeks of treatment."
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 brain wave recordings (EEG) can help improve a magnetic brain treatment for depression called iTBS, a type of TMS. It is for adults ages 22–60 with major depression that has not improved with an antidepressant, or who could not tolerate two antidepressants. Everyone receives active treatment, with magnetic pulses timed to one of three points in a brain wave.

The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD). This is a feasibility study to test a "closed-loop" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.

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

Eligibility

Who can join

  • Be ages 22–60, receive care without staying in a hospital, and freely agree to treatment and the study.
  • Have major depression confirmed by a study interview, with a score of at least 18 on a depression rating scale. The current episode must last at least 4 weeks but less than 2 years.
  • Have not improved enough with an antidepressant taken at an adequate dose during this episode, or have tried two antidepressants that you could not tolerate.
  • Have no new mental health medicines or dose changes, and no major changes in talk therapy, during the 4 weeks before screening.
  • Be able to safely receive TMS and follow the study and treatment schedule. Use medically accepted birth control if you can become pregnant.
  • Stay under the care of a licensed psychiatrist or other mental health provider throughout the study, and promptly report provider changes.
  • Allow study staff to contact healthcare providers who treated you within at least the past 2 years to check eligibility or address safety concerns.
  • Provide contact details for at least two people age 22 or older who live within a reasonable drive of your home. Allow staff to contact them if they cannot reach you.

Who can't join

  • A history of a substance use disorder, including alcohol.
  • The study lists major illness and certain brain, nerve, or heart conditions within the past 3 months. These include stroke, brain injury, seizures, multiple sclerosis, brain infections or cancers, and moderate to severe heart disease. Pacemakers, implanted devices, and medicine pumps are also listed.
  • A parent, sibling, or child with epilepsy or seizures, unless the cause is known not to be genetic.
  • Any reason TMS or MRI would be unsafe for you.
  • Current intent to end your life, or a moderate to high suicide risk based on the study team's review.
  • Being pregnant or breastfeeding.
  • A history of mania or hypomania—unusually high energy or mood—or certain recent conditions that may cause them; a score of 12 on a mania scale; a lifetime diagnosis of bipolar disorder, schizophrenia, or certain related disorders; or current psychotic symptoms, such as seeing things that are not there.
  • Taking bupropion (Wellbutrin) or antipsychotic medicines.

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

Official eligibility criteria

Inclusion Criteria: * Outpatients * Voluntary patient seeking treatment with the capacity to consent * 22-60 years of age * Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57 * Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable * Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS * In a current episode of MDD with duration of at least 4 weeks but less than 2 years * Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening * Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire * On a medically acceptable form of birth control if capable of becoming pregnant * Are able to adhere to the protocol and treatment schedule * Currently and throughout study participation is under the care of a licensed psychiatrist and/or other mental health care provider and agrees to promptly inform the investigator or study staff of any change in such provider(s). * Agrees to allow any and all forms of communication between the investigators and study staff with any healthcare provider who has provided service to the patient/participant within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event. * Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within reasonable driving time of the patient's home address. Participant also agrees that research personnel are at liberty to contact these individuals if the participant is unable to be contacted. Exclusion Criteria: * Have a history of a substance use disorder (including alcohol) * Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., "non-idiopathic"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps * Contraindications for TMS or MRI * Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale. * Pregnant and lactating patients * As determined by the Principal Investigator (PI), has: (a) a lifetime history of mania or hypomania symptoms from any cause; (b) a medical condition or diagnosis, within 1 year of screening, that seems somewhat likely to cause such symptoms; or (c) scores 12 on the Young Mania Rating Scale. * Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms. * Patients taking bupropion/Wellbutrin or antipsychotics are excluded

Study sites (1)

MN