In-patient SCC TMS

NCT05645575 | Recruiting

• 1 other identifier: 22-000810
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are studying the feasibility, safety, and tolerability of administering accelerated repetitive Transcranial magnetic stimulation(a-rTMS) at frequencies other than standard 10 Hz for in-patient Subjects diagnosed with Major Depressive Disorder. Participants will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 participants who will undergo up to three brain activity recordings, one MRI scan, one TMS procedure to determine the appropriate frequency and intensity for treatment, daily symptom assessments, and 25 TMS treatments. Participants will be asked to participate for up to 2 weeks.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy as Measured by Change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Final Visit

  Treatment efficacy as measured by change in Inventory of Depressive Symptoms (Self-Report) at Baseline and Week 8 visit. This is a 30-item questionnaire with minimum and maximum score values ranging from 0 to 84. Higher scores indicate a worse outcome and lower scores indicate better outcome.

  2 Weeks (Baseline and Final Visit)

Secondary Outcomes (1)

• Treatment Efficacy as Measured by Change in Patient Health Questionnaire-9 (PHQ-9) at Baseline and Final Visit.

  2 Weeks (Baseline and Final Visit)

Study Arms (1)

Open-label TMS

EXPERIMENTAL

Device: Open-label TMS

Interventions

Open-label TMS DEVICE

Customized, Open-Label Transcranial Magnetic Stimulation

Also known as: Transcranial Magnetic Stimulation

Open-label TMS

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 between 18-65 years of age.
• Must have confirmed diagnosis of moderate to severe Major Depressive Disorder (single or recurrent episode) as defined by a HAM-D score of 17 or higher.
• 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 accelerated treatment schedule.

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 present in the body scan, 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.)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA TMS Service and Research Service

Los Angeles, California, 90024, United States

RECRUITING

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

Central Study Contacts

Nikita Vincecruz, BS

CONTACT

310-825-4781; nvincecruz@mednet.ucla.edu

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 the Neuromodulation Division at the Semel Institute

Model Details: Open-label Transcranial Magnetic Stimulation Treatment

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): February 22, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

US (1)