Major depressive disorder surgery
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Mitra Chitsazan, M.D.[2]
Surgery
Cranial Electrotherapy Stimulation
Cranial electrotherapy stimulation devices (CES devices) use electrodes placed on or just behind the ear to generate a very small electrical current. In normal healthy males this microcurrent has been shown to affect alpha wave and beta wave brain activity, which according to the authors,"suggest beneficial changes in mental state". [1] Unlike transcranial magnetic stimulation and vagus nerve stimulation, CES devices are small, relatively inexpensive, and are designed for home use. Unlike vagus nerve stimulation, no surgery is required.
Several double-blind studies of mixed groups of psychiatric patients have been conducted in the 1970s. The results were inconclusive and negative in one of these trials.[2] In another trial, no difference between the placebo and treatment groups were found on any of the five measures employed.[3] A third trial reported overall inconclusive results; however, four out of six clinically depressed patients dropped out of the study because of the massive worsening of depressive symptoms, with two of them becoming actively suicidal.[4] One of the authors of the third study cautioned that CES “should not be used as a treatment of choice” for the patients with the primary diagnosis of depression, “and should be used with caution if this diagnosis is suspected.”[5] Many preliminary, small-scale studies have been conducted which show the effectiveness of CES therapy;[6][7][8][9] however, to date there exists no consensus or even prospective clinical trials to support its use.
All of the CES devices currently on the market have been granted marketing authorization by the FDA based on the legacy waver, that is because a sufficiently similar device had been marketed before 1976, when the new regulations requiring controlled testing were introduced.[10] Such approval is sometimes misunderstood as evidence of efficacy, it should only be taken as lack of evidence of harm. The FDA considers them to be the class III devices—"devices for which insufficient information exists to assure that general controls and special controls provide reasonable assurance of safety and effectiveness."[11]
Vagus Nerve Stimulation
Vagus nerve stimulation therapy is a treatment used since 1997 to control seizures in epileptic patients and has recently been approved for treating resistant cases of treatment-resistant depression (TRD). The VNS Therapy device is implanted in a patient's chest with wires that connect it to the vagus nerve, which it stimulates to reach a region of the brain associated with moods. The device delivers controlled electrical currents to the vagus nerve at regular intervals.
References
- ↑ Elsevier
- ↑ Moore JA, Mellor CS, Standage KF, Strong H (1975). "A double-blind study of electrosleep for anxiety and insomnia". Biol. Psychiatry. 10 (1): 59–63. PMID 1091305.
- ↑ Passini FG, Watson CG, Herder J (1976). "The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients". J. Nerv. Ment. Dis. 163 (4): 263–6. PMID 972328.
- ↑ Feighner JP, Brown SL, Olivier JE (1973). "Electrosleep therapy. A controlled double blind study". J. Nerv. Ment. Dis. 157 (2): 121–8. PMID 4724809.
- ↑ Feighner JP (1971). "Electrosleep Therapy: Current Usage in Psychiatry". Calif. Med. 115 (3): 44. Retrieved 2007-12-02.
- ↑ JN 9(2) print.pdf
- ↑ http://www.maxilife.co.za/download/healthguides/HG27-CES%20in%20the%20Treatment%20of%20Depression.pdf
- ↑ IngentaConnect Cranial Electrotherapy Stimulation Review A Safer Alternative to
- ↑ http://www.depressiontreatmentnow.com/bioelectric_medicine.pdf
- ↑ FDA > CDRH > CFR Title 21 Database Search
- ↑ FDA 515(i) Reclassification Letter to Manufacturers