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In-patient SCC TMS

Pilot Study: Evaluating the Feasibility of Accelerated rTMS Treatment Delivered at Individual Resonant Frequencies for In-patient Subjects Suffering From Major Depressive Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks, 5 days
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Patients will first undergo a brief (10-15 min) magnetic resonance imaging (MRI) for the purpose of neuronavigation to the optimal anatomical site."
  • "Patients will receive 5 a-rTMS sessions daily for five days with a minimum interval of 1 hour between sessions."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a faster schedule of TMS, which uses magnetic pulses to stimulate the brain, is safe, manageable, and practical at pulse rates other than the usual 10 pulses per second. It is for adults staying at Resnick Neuropsychiatric Hospital with moderate to severe major depression that has not improved with treatment. Participants will receive 25 TMS treatments and other tests over up to 2 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Have confirmed moderate to severe major depression, with a score of at least 17 on the HAM-D depression rating scale.
  • Have tried at least 2 antidepressant medicines without improvement.
  • Have tried medicines from at least 2 different drug types without improvement.
  • Have also tried at least 2 proven add-on treatments. Benzodiazepines, a type of calming medicine, do not count.
  • Have tried proven talk therapy for depression, often enough and for long enough to count as an adequate trial.
  • Be willing and able to follow the faster treatment schedule.

Who can't join

  • Be unable to give informed consent because of a mental or legal limitation.
  • Have an infection or unhealthy skin on the scalp where the device will sit.
  • Have a higher seizure risk because of family history, stroke, or medicines you currently take.
  • Have symptoms or a disorder involving loss of touch with reality during the current period of depression.
  • Have epilepsy, disease of the brain's blood vessels, dementia, high pressure inside the skull, repeated or severe head injuries, or tumors in the brain or spinal cord.
  • Have an implanted medical device or metal that is sensitive to magnets, such as a hearing implant, heart device, nerve stimulator, or certain clips, coils, staples, or stents. Metal dental fillings are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. All subjects must be between 18-65 years of age. 2. 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. 3. Failure to respond to a minimum of 2 trials of antidepressant medication 4. Failure to respond from at least two different agent classes 5. Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines do not count). 6. Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration. 7. Subjects are willing and able to adhere to the accelerated treatment schedule. Exclusion Criteria: 8. Are mentally or legally incapacitated, unable to give informed consent 9. Have an infection or poor skin condition over the scalp where the device will be positioned 10. Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure 11. Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode. 12. 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. 13. 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.)

Study sites (1)

CA