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ENROLLING BY INVITATION

NCT06572683

Resonant Frequency rTMS: A Novel Approach to Target Circuit Modulation in Major Depressive Disorder

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

Summary

The purpose of the study is to develop a more personalized brain stimulation using repetitive transcranial magnetic stimulation or rTMS approach to treat major depressive disorder (MDD). The investigators had previously developed a personalized rTMS treatment by examining the effectiveness of different rTMS frequency from 5 to 18 Hertz (Hz). The optimal treatment frequency is termed resonance frequency and varies across individuals. There has not been a systematic method to identify the best stimulation frequency in an individual-specific way. In this project, the investigators will identify and compare 3 rTMS frequencies, all targeting the brain region called left dorsolateral prefrontal cortex (DLPFC): 1 that engages brain circuit connectivity the most- the investigators call this resonant frequency (RF)-max (RF-max), 1 that is the lowest ranked resonance frequency called RF-min and 1 that is standard of care treatment - rTMS of 10 Hz as a point of comparison. This study is a multi-sites project that will be conducted at UCLA and Butler hospital. This study will enroll 84 participants with MDD over the course of 4.5 years. Participants will undergo a brain imaging scan or magnetic resonance imaging (MRI), 3 electroencephalograms (or EEG, a measurement of electrical activity of the brain), to identify rTMS resonance frequencies (RFs), 3 sessions of different resonant frequencies of rTMS in combination with EEG, totaling up to 7 in person visits. Participation will take up to 4 weeks.

Key Details

Gender

All

Age Range

21 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-02-12

Completion Date

2028-10-31

Last Updated

2025-09-22

Healthy Volunteers

Conditions

MDD Depression

Interventions

DEVICE

Transcranial Magnetic Stimulation

Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. Using pulsed magnetic fields, transcranial magnetic stimulation therapy stimulates the part of the brain thought to be involved with mood regulation. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil.As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain, causing them to rewire, a process called neuroplasticity.

Inclusion Criteria: * All subjects must be between 21-75 years of age. * Must have confirmed diagnosis of severe \*Major Depressive Disorder (single or recurrent episode) as confirmed by the Mini-International Neuropsychiatric Interview (MINI) or/and a score of 17 or above on the Hamilton Depression Rating Scale (HAMD). * Failure to respond to a minimum of 2 trials of antidepressant medication. * Failure to respond from at least two different agent classes. * Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count). * Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration. * Subjects are willing and able to adhere to the treatment schedule and required study visits. * TMS treatment is clinically-approved only for those suffering from Major Depressive Disorder as their primary diagnosis. Exclusion Criteria: * Are mentally or legally incapacitated, unable to give informed consent * Have an infection or poor skin condition over the scalp where the device will be positioned. * Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure. * Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode. * Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system. * Presence of an implanted magnetic-sensitive medical device present in the body scan, located less than or equal to 30 centimeters from the transcranial magnetic stimulation magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation and MRI.) * Current diagnosis of substance use disorder.

Locations (1)

University of California

Los Angeles, California, United States