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.
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
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.
- Conditions
- Convulsion, Non-Epileptic
- 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 group | Role | What they receive |
|---|---|---|
| Auricular acupuncture | Experimental | Subjects 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.
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)
Adverse Events
We will report the types and rates of any adverse events collected from subject diaries.
Measured: 16 Weeks
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
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.
- First posted9 Aug 2013 (estimated)
- Study startMay 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Convulsion, Non-EpilepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Maa, Denver Health and Hospital Authority
- Investigators
- Edward Maa, MD, Principal investigator, Denver Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures
- ClinicalTrials.gov ID
- NCT01919307
- Acronym / sponsor ID
- 12-0313
- Conditions
- Convulsion, Non-Epileptic
- Keywords
- Seizures, Convulsions, Anticonvulsants, Epilepsy, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture | Experimental | Other: Auricular acupunctureSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureThe 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. | Other | Auricular acupuncture |
Primary outcome
Completion Rate of Auricular Acupuncture in Patients With NES
Time frame: 8 Weeks
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.
3 secondary outcomes
Adverse Events
Time frame: 16 Weeks
Compliance Rates of NES Seizure Diary
Time frame: 16 Weeks
Trend for Auricular Acupuncture to Reduce NES Frequency
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Maa, MD principal investigator
Denver Health
1 site in 1 country: see every site and its status.
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.