Spectral TMS (s-TMS)

NCT04040062 | Enrolling By Invitation FDA Device

• 1 other identifier: 19-0758
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will analyze the feasibility, safety, and tolerability of administering repetitive Transcranial magnetic stimulation(TMS) at frequencies other than standard 10 Hz. This study will enroll 50 subjects who will undergo one quantitative electroencephalograph, one TMS procedure to determine the appropriate frequency and intensity for treatment, weekly mood/symptom assessments, and up to 30 TMS treatments. Subjects will be asked to participate for up to 6 weeks.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Inventory of Depressive Symptoms- Self report

  This survey is designed to assess the severity of depressive symptoms. The IDS assess all the criterion symptom domains designated by the American PsychiatryAssociation Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) (APA1994) to diagnose a major depressive episode. These assessments can be used to screen fordepression, although they have been used predominantly as measures of symptom severity. The seven day period prior to assessment is the usual time frame for assessing symptom severity.

  Weekly

Study Arms (1)

SCC

EXPERIMENTAL

Subjects will be treated according to their frequency response pattern which may show one or more distinct frequencies of stimulation that generated increased SCC

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

SCC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must be over between 18-65 years of age.
• Must have confirmed diagnosis of severe Major Depressive Disorder (single or recurrent episode).
• Failure to respond to a minimum of 4 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of UCLA Neuromodulation

Model Details: We will identify the participant's individual spectral correlation coefficient (SCC) by stimulation with 68 different stimulation pulse trains of 40 pulses each at frequencies ranging between 3 and 20 Hz in steps of 0.25 Hz, plus intermittent theta burst (iTBS) stimulation, in randomized order. We will then select the frequency with the largest connectivity density (strong and focal connectivity increase within the fronto-parietal control network) in the range of 3 and 20 Hz as the optimal individual stimulation density and treat the participants at this optimal Hz for the duration of the study.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 31, 2019
• Study Start: June 25, 2019
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (1)