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Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01919307
Enrollment
29
Registered
2013-08-09
Start date
2012-05-31
Completion date
2016-01-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Convulsion, Non-Epileptic

Keywords

Seizures, Convulsions, Anticonvulsants, Epilepsy, Neurologic

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.

Interventions

OTHERAuricular acupuncture

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.

Sponsors

Denver Health and Hospital Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Completion Rate of Auricular Acupuncture in Patients With NES8 WeeksOf subjects who receive the first Auricular Acupuncture treatment, we will measure the percentage that goes on to complete the entire 8 week active treatment period.

Secondary

MeasureTime frameDescription
Compliance Rates of NES Seizure Diary16 WeeksFor each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.
Adverse Events16 WeeksWe will report the types and rates of any adverse events collected from subject diaries.
Trend for Auricular Acupuncture to Reduce NES Frequency16 weeksOf subjects completing the 8 week active treatment period, we will compare each subject's 1 month baseline frequency with frequency immediately upon completion of the active treatment period, and at 1 month follow up (3 months after baseline)

Countries

United States

Participant flow

Participants by arm

ArmCount
Auricular Acupuncture
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.
29
Total29

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyWithdrawal by Subject9

Baseline characteristics

CharacteristicAuricular Acupuncture
Age, Continuous40 years
STANDARD_DEVIATION 11
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
25 Participants
Sex: Female, Male
Female
21 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 29
other
Total, other adverse events
0 / 29
serious
Total, serious adverse events
0 / 29

Outcome results

Primary

Completion Rate of Auricular Acupuncture in Patients With NES

Of subjects who receive the first Auricular Acupuncture treatment, we will measure the percentage that goes on to complete the entire 8 week active treatment period.

Time frame: 8 Weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Auricular AcupunctureCompletion Rate of Auricular Acupuncture in Patients With NES15 Participants
Secondary

Adverse Events

We will report the types and rates of any adverse events collected from subject diaries.

Time frame: 16 Weeks

ArmMeasureCategoryValue (COUNT_OF_UNITS)
Auricular AcupunctureAdverse EventsNausea5 Adverse Events
Auricular AcupunctureAdverse EventsDizziness4 Adverse Events
Auricular AcupunctureAdverse EventsHeadache6 Adverse Events
Auricular AcupunctureAdverse EventsPain/Tenderness9 Adverse Events
Auricular AcupunctureAdverse EventsSkin Irritation1 Adverse Events
Auricular AcupunctureAdverse EventsWeakness1 Adverse Events
Auricular AcupunctureAdverse EventsSleepiness3 Adverse Events
Auricular AcupunctureAdverse EventsPanic/Anxiety2 Adverse Events
Auricular AcupunctureAdverse EventsSeizure12 Adverse Events
Auricular AcupunctureAdverse EventsHospital Visit3 Adverse Events
Auricular AcupunctureAdverse EventsWithdrawal from Study9 Adverse Events
Auricular AcupunctureAdverse EventsOther9 Adverse Events
Secondary

Compliance Rates of NES Seizure Diary

For each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.

Time frame: 16 Weeks

ArmMeasureValue (MEAN)Dispersion
Auricular AcupunctureCompliance Rates of NES Seizure Diary90 percentage of completed diary entriesStandard Deviation 8
Secondary

Trend for Auricular Acupuncture to Reduce NES Frequency

Of subjects completing the 8 week active treatment period, we will compare each subject's 1 month baseline frequency with frequency immediately upon completion of the active treatment period, and at 1 month follow up (3 months after baseline)

Time frame: 16 weeks

ArmMeasureGroupValue (MEAN)Dispersion
Auricular AcupunctureTrend for Auricular Acupuncture to Reduce NES FrequencyBaseline15 Number of Seizures per WeekStandard Deviation 16
Auricular AcupunctureTrend for Auricular Acupuncture to Reduce NES FrequencyTreatment13 Number of Seizures per WeekStandard Deviation 16
Auricular AcupunctureTrend for Auricular Acupuncture to Reduce NES FrequencyWashout16 Number of Seizures per WeekStandard Deviation 36

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026