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Author: admin, 27.03.2014. Category: Severe Tinnitus Symptoms

Vagus Nerve Stimulation Therapy has been used since 1997 to alleviate seizures in epileptic patients. Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. JavaScript is currently disabled, this site works much better if you enable JavaScript in your browser. It has recently been approved for treating cases of treatment-resistant depression (TRD).
Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. The VNS-Therapy device is implanted in a patient’s chest, which has wires connected to the vagus nerve. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research.
When the nerve is stimulated, the region in the brain linked with moods is also stimulated. In some cases, however, the underlying mental or physical condition of the individual may alter his or her cognitive abilities and compromise the informed consent process. The device sends controlled electrical impulses to the vagus nerve at regular time-periods as a unique method for depression treatment.
Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure.


This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. Empirical advances in the assessment of the capacity to consent to medical treatment: clinical implications and research needs.
Cultural influences on the physician-patient encounter: The case of shared treatment and decision-making. Financial capacity in persons with schizophrenia and serious mental illness: clinical and research ethics aspects.
Pharmacologic strategies for treatment-resistant depression: An update on the state of the evidence.
Partial response and nonresponse to antidepressant therapy: current approaches and treatment options.
Vagus nerve stimulation for treatment-resistant depression: A randomized, controlled acute phase trial.
Effects of 12 months of vagus nerve stimulation in treatment-resistant depression: A naturalistic study. Vagus nerve stimulation (VNS) for treatment-resistant depression: Efficacy, side effects, and predictors of outcome.


Willingness and competence of depressed and schizophrenic inpatients to consent to research. Ethical considerations in psychopharmacological research involving decisionally impaired subjects. Neurosurgical experience with malpractice litigation: an analysis of closed claims against neurosurgeons in New York state, 1999 through 2003. An empirical analysis of the medical informed consent doctrine: search for a “standard of disclosure”.
Involuntary hospitalization of medical patients who lack decisional capacity: An unresolved issue. Hospital informed consent for procedure forms: facilitating quality patient-physician interactions. Converting the informed consent from a perfunctory process to an evidence-based foundation for patient decision making. The relative importance of physician communication, participatory decision making, and patient understanding in diabetes self-management.
Criteria for patient decision making (in)competence: a review of and commentary on some empirical approaches.



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