Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

NCT01919307 | Completed Results

• 1 other identifier: 12-0313
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Convulsion, Non-Epileptic

Keywords

Seizures; Convulsions; Anticonvulsants; Epilepsy; Neurologic

Outcome Measures

Primary Outcomes (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.

  8 Weeks

Secondary Outcomes (3)

• Adverse Events

  16 Weeks

• Compliance Rates of NES Seizure Diary

  16 Weeks

• Trend for Auricular Acupuncture to Reduce NES Frequency

  16 weeks

Study Arms (1)

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.

Other: Auricular acupuncture

Interventions

Auricular acupuncture OTHER

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.

Auricular acupuncture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsy; Neurologic Manifestations

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Results Point of Contact

• Title: Edward Maa
• Organization: Denver Health and Hospital Authority

Edward.Maa@dhha.org

303-602-5099

Study Officials

• Edward Maa, MD

  Denver Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Comprehensive Epilepsy Program

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 9, 2013
• Study Start: May 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 5, 2018
• Results First Posted: December 18, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)