Status:
ENROLLING_BY_INVITATION
Spectral Correlation Coefficient-based TMS
Lead Sponsor:
University of California, Los Angeles
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed Description
The therapeutic benefit of repetitive Transcranial Magnetic Stimulation (rTMS) for the treatment of Major Depressive Disorder (MDD) is thought to depend upon engagement of brain functional networks (F...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04040062
Start Date
June 25 2019
End Date
October 1 2027
Last Update
September 9 2025
Active Locations (1)
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1
University of California
Los Angeles, California, United States, 90024