Abstracts

Rationale: Major depression (MD) is a big problem in epilepsy. Patients with epilepsy (PWE) are four times more likely to have been hospitalized for MD than comparable patients without epilepsy (Mendez, 1986). While some (Kanner, 2013) advocate for more aggressive treatment with standard antidepressant medications, concerns regarding lowered seizure threshold and adverse interactions with antiepileptic drugs continue to limit implementation. Alternative treatments are urgently needed. Transcranial magnetic stimulation (TMS) is a non-invasive neuromodulatory technology with proven efficacy in treating MD. The estimated risk of seizure induction by TMS in routine clinical use in patients without epilepsy is 0.1% (George, 2013). Concerns over this potential seizure risk have had a chilling effect on the study of TMS to treat MD in PWE. A recent search of ClinicalTrials.gov (5/28/14) for Phase 3 trials using terms "TMS" and "Depression" generated 28 trials of which 2 did not involve TMS as a treatment and one did not include any exclusion criteria. Of the remaining 25 trials, all excluded patients with a history of seizures or epilepsy. One of the chief principles of informed consent is respect for autonomy. As far as we know, no one has asked PWE what is their attitude towards trying a new treatment as a function of risk of seizure induction. Methods: We presented a brief anonymous survey to patients in a general neurology clinic at the Pittsburgh VA hospital during March-April 2014. The survey consisted of Yes/No or Likert-scale questions on a single-sided sheet. The survey assessed age, gender, seizure history (SzHx), anxiety/depression symptoms (PHQ4), and the degree of reported side effects from antidepressant medications. Finally, five questions assessed willingness to try a new antidepressant/anxiolytic treatment at the cost of varying levels of risk of inducing a seizure (from 1/10 chance to 1/10000 chance). Results: Survey refusal was under 5%. Of the 198 respondents, 177 were men and 28% had history of seizures (SzHx+) with median time since last seizure of 1yr. Mean age of sample = 57+14y (23y to 89y). Measures of depression, anxiety, degree of side effects from medication for depression/anxiety, did not differ between veterans with and without seizures. Amongst those willing to try a new treatment there was a trend for SzHx+ to be more willing to accept risk of seizures than the SzHx- group (P< 0.08, Cochran Armitage Trend Test). Conclusions: Over a quarter of a sample of US veterans with history of seizures was willing to try a new antidepressant treatment even when presented with risk of seizure induction of 0.5% or greater. There is no evidence that patients with seizure history are more risk averse than those without seizures. Based on our survey results, the reverse may be true. There is no ethical justification for excluding patients with history of seizures or epilepsy from MD treatment trials involving TMS. Such trials seem urgently needed for the treatment of MD in PWE. Support: US Dept Veterans Affairs; content does not represent views of VA/US gov.