Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

Formerly referred to as "psychogenic" or "pseudo" seizures, Non-Epileptic Seizures (NES) are
a physical manifestation of a psychological disturbance and are a type of Somatoform Disorder
called a conversion disorder. NES are a significant neurological condition occurring with a
prevalence of 2 to 33 per 100,000, similar to that of Multiple Sclerosis. Patients suffering
from this phenomenon exhibit seizure-like behavior without electrophysiological correlate,
and as would be expected, anti-epileptic drugs (AED) are not effective in treating this
disorder. These patients are large consumers of health care resources, are frequently
unemployed, require public assistance safety-net programs, and are difficult to properly
diagnose without the aid of Epilepsy Monitoring Units (EMU). Furthermore, even after proper
diagnosis in an EMU, there is no consensus standard of care therapy for this form of
conversion disorder. Most frequently patients are referred for mental health therapy
(Cognitive Behavioral Therapy) which is frequently not pursued by the patient due to poor
access, poor insight, or stigma.

In a survey of our refractory epilepsy clinic, 68% of respondents are using some form of CAM
or Complementary and Alternative Medicine, compared with 39% in a Midwestern population. CAM
may offer a solution to access and interest-in-therapy in a population of patients
experiencing a high frequency of debilitating events, including NES.

As a complementary and alternative medicine, acupuncture is felt to be a safe and
cost-effective therapeutic approach to the treatment of many diseases and symptoms. While the
effect of acupuncture for the treatment of epilepsy has been equivocal, studies in the
setting of mental health disorders such as post-traumatic stress disorder and anxiety have
been promising. Auricular acupuncture has been specifically studied in cocaine dependence,
smoking cessation, dental anxiety, and PTSD.

Our interest in acupuncture and NES results from studies that show evidence that acupuncture
may improve other conversion disorders presenting as psychogenic movement disorders, or
psychogenic erectile dysfunction (16). There also appears to be measurable changes in
parasympathetic and sympathetic balance attributable to acupoint stimulation, that may
explain anecdotal reports of stress and seizure reduction from acupuncture. It should also be
noted that the Vagus Nerve Stimulator, an implantable device that controls medically
refractory epileptic seizures, and presumably modulates parasympathetic tone, was first
approved as adjunctive therapy in pharmacologically resistant epilepsy by the FDA in 1997 and
was later approved for treatment-resistent depression in 2005.

Based on this literature we are conducting an un-blinded treatment trial to establish if
auricular acupuncture can effect seizure frequency in NES, and to help design a large
double-blind, placebo-controlled clinical trial to determine the efficacy of auricular
acupuncture as a treatment for NES. In addition to potentially uncovering an effective
treatment for NES, this research will add to our empiric knowledge of acupuncture in
conversion disorders such as NES and stimulate further research in acupuncture and NES, both
understudied areas.

Inclusion Criteria:

1. Diagnosis of non-epileptic seizures, confirmed by ictal routine EEG or ictal video EEG

2. Age 18-75

3. Ability to provide informed consent and comply with study activities

4. > 2 NES per month

Exclusion Criteria:

1. Serious mental health disorder or medical or neurological illness (requiring systemic
treatment and/or hospitalization) until subject either completes therapy or is
clinically stable on therapy, in the opinion of the site investigator, for at least 30
days prior to study entry.

2. Pregnancy, self-discovered pregnancy, lactation, or plans to become pregnant.

3. Inability to distinguish between NES and comorbid epileptic seizures.

4. Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.

5. Inability or unwillingness of subject or legal guardian/representative to give written
informed con-sent.