Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures
Condition: Convulsion, Non-Epileptic
MeSH terms: Seizures
Study type: Interventional

Summary: 
      This feasibility study will determine the tolerability of auricular acupuncture, compliance
      with self-reported seizure tracking, and the quality of a proposed sham acupuncture protocol
      to inform the design of a large, multi-center, placebo-controlled, double-blind study to
      demonstrate the therapeutic effect of auricular acupuncture for the treatment of
      Non-Epileptic Seizures.
    

Detailed description: 
      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.
    

Intervention name(s): Auricular acupuncture
Intervention type(s): Other
Intervention description(s): The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Seizures; Convulsions; Anticonvulsants; Epilepsy; Neurologic