Major Depression, Repetitive Transcranial Magnetic Stimulation
Conditions
Keywords
rTMS
Brief summary
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. The study is looking at changes in specific electroencephalogram parameters in depressed patients treated with rTMS can serve as predictors of depression treatment response among cancer patents undergoing rTMS treatment of depression.
Detailed description
The study will be a prospective, single arm trial in which a set of patients who will be treated for major depression using Repetitive Transcranial Magnetic Stimulation (according to FDA approved rTMS standard care practices) also will undergo EEG recording before Repetitive Transcranial Magnetic Stimulation treatment begins, and at the completion of treatment. The Hamilton Depression Rating Scale will be given to participants by the neuropsychiatrist at baseline and weekly intervals till the completion of treatment. The neuropsychiatrist investigators expect to see about 12 patients per year who meet treatment criteria for Repetitive Transcranial Magnetic Stimulation. Therefore, it is expected to recruit 24 subjects into the research study over a two-year period.
Interventions
DIAGNOSTIC_TESTElectroencephalogram (EEG)
EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage.
Sponsors
Florida International University
Baptist Health South Florida
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with cancer * Comorbid diagnosis of major depressive disorder * Age ≥ 18 years * Baseline Hamilton Depression Rating Scale (HDRS) score ≥ 18 * Failed one or more adequate antidepressant trials (including selective serotonin reuptake inhibitors or SSRIs, selective norepinephrine reuptake inhibitors or SNRIs, tricyclic antidepressants or TCAs). A failed treatment response may be due to lack of antidepressant efficacy or intolerable side effects.
Exclusion criteria
* History of seizure or epilepsy * History of concussion * History of bipolar disorder * Comorbid psychotic disorder * Primary brain tumor or metastasis to brain * Active comorbid substance use disorder * History or current diagnosis of dementia * Current pregnancy * Unable to attend regular treatment sessions * Any other condition in which a physician investigator feels may subject the participant to undue risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hamilton Depression Rating Scale score | baseline, and weekly until study completion, which can be up to 6 weeks | Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electroencephalograph (EEG) scalp signal changes over time | baseline, end of treatment, which can be up to 6 weeks | Change in brain activity as measured by the EEG in microvolts.Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA). |
Countries
United States
Outcome results
None listed