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Convulsion, Non-EpilepticNCT01919307

Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

A study testing Auricular acupuncture in people with Convulsion, Non-Epileptic, run by Denver Health and Hospital Authority at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Convulsion, Non-Epileptic
What is being tested?
Auricular acupuncture
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
May 2012to Jan 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of non-epileptic seizures, confirmed by ictal routine EEG or ictal video EEG
  • Age 18-75
  • Ability to provide informed consent and comply with study activities
  • > 2 NES per month

Who cannot join

  • 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.
  • Pregnancy, self-discovered pregnancy, lactation, or plans to become pregnant.
  • Inability to distinguish between NES and comorbid epileptic seizures.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of subject or legal guardian/representative to give written informed con-sent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Denver Health Medical Center

    Denver, Colorado, 80204

Other trials in United States

About this study

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.

Read the 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.

Being tested
Auricular acupuncture
Keywords
Seizures, Convulsions, Anticonvulsants, Epilepsy, Neurologic
Medical subject headings
Seizures, Epilepsy, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular acupunctureOther

    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.

Study groups in NCT01919307
Study groupRoleWhat they receive
Auricular acupunctureExperimentalSubjects will then receive auricular acupuncture (NADA Protocol) twice weekly for eight consecutive weeks. Subjects will be evaluated for seizure frequency changes by self-reported diary; adverse events; study feasibility; and mental and physiological symptoms at baseline, 12 weeks (completion of acupuncture), and 16 weeks (1 month after treatment follow up, end of study). A single sham procedure will be tested following treatment completion for use in future studies.
Receives: Other: Auricular acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 Weeks

Secondary outcomes (3)
  1. Adverse Events

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

    Measured: 16 Weeks

  2. 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.

    Measured: 16 Weeks

  3. 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)

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2013 (estimated)
  2. Study startMay 2012
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919307
Sponsor's protocol ID
12-0313
Status last verified
Jan 2018
First submitted
7 Aug 2013
Last updated
5 Feb 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing Auricular acupuncture in people with Convulsion, Non-Epileptic, run by Denver Health and Hospital Authority at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate of Auricular Acupuncture in Patients With NES (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.

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Clinical Trial NCT01919307 | AzTrials