Clinical trial NCT01919307: Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures
Official title: Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Convulsion, Non-Epileptic
Keywords: Seizures
Convulsions
Anticonvulsants
Epilepsy
Neurologic
Lead sponsor: Denver Health and Hospital Authority
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion Rate of Auricular Acupuncture in Patients With NES
timeFrame: 8 Weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 16 Weeks
measure: Compliance Rates of NES Seizure Diary
timeFrame: 16 Weeks
measure: Trend for Auricular Acupuncture to Reduce NES Frequency
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: Denver Health
name: Edward Maa, MD
role: PRINCIPAL_INVESTIGATOR
References: