Open Actively Recruiting

In-patient SCC TMS

About

Brief Summary

We 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. Subjects will be recruited from the Resnick Neuropsychiatric Hospital. This study will enroll 30 subjects 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. Subjects will be asked to participate for up to 2 weeks.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
65 Years

Inclusion Criteria:

  • 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. 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, 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.)

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Study Stats
Protocol No.
22-000810
Category
Semel Institute (Psychiatry)
Principal Investigator
Contact
Nikita Vincecruz
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05645575
For detailed technical eligibility, visit ClinicalTrials.gov.