N/A
N=29
Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures
Convulsion, Non-Epileptic
Bottom Line
View on ClinicalTrials.gov: NCT01919307 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Completion Rate of Auricular Acupuncture in Patients With NES — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Auricular acupuncture (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate of Auricular Acupuncture in Patients With NES |
15 | — |
| SECONDARY Adverse Events |
5; 4; 6; 9; 1; 1 | — |
| SECONDARY Compliance Rates of NES Seizure Diary |
90 | — |
| SECONDARY Trend for Auricular Acupuncture to Reduce NES Frequency |
15; 13; 16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01919307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.