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Study was closed due to lack of resources
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| Name | Class |
|---|---|
| Florida International University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroencephalogram (EEG) | All participants will undergo EEG recording at baseline and end of treatment for a duration of 10-20 minutes per session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalogram (EEG) | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale score | Hamilton Depression Rating Scale is used to measure severity of depression on a scale from 0 (no depression) to 52 (most severe depression). | baseline, and weekly until study completion, which can be up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalograph (EEG) scalp signal changes over time | 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). | baseline, end of treatment, which can be up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who will be treated for major depression using rTMS (according to standard care)
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| Name | Affiliation | Role |
|---|---|---|
| Geetha Nampiaparampil, MD | Miami Cancer Institute (MCI) at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Starlie C Belnap | Miami | Florida | 33176 | United States |
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| Label | URL |
|---|---|
| Miami Neuroscience Institute | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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