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Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

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ClinicalTrials.gov Identifier: NCT01919307
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : December 18, 2017
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Edward Maa, Denver Health and Hospital Authority

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Convulsion, Non-Epileptic
Intervention Other: Auricular acupuncture
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 29
Completed 20
Not Completed 9
Reason Not Completed
Withdrawal by Subject             9
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
40  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
21
  72.4%
Male
8
  27.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Hispanic or Latino
13
  44.8%
Not Hispanic or Latino
16
  55.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  10.3%
White
25
  86.2%
More than one race
0
   0.0%
Unknown or Not Reported
1
   3.4%
1.Primary Outcome
Title Completion Rate of Auricular Acupuncture in Patients With NES
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Measure Type: Count of Participants
Unit of Measure: Participants
15
  51.7%
2.Secondary Outcome
Title Adverse Events
Hide Description We will report the types and rates of any adverse events collected from subject diaries.
Time Frame 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Overall Number of Units Analyzed
Type of Units Analyzed: Adverse Events
64
Count of Units
Unit of Measure: Adverse Events
Nausea
5
   7.8%
Dizziness
4
   6.3%
Headache
6
   9.4%
Pain/Tenderness
9
  14.1%
Skin Irritation
1
   1.6%
Weakness
1
   1.6%
Sleepiness
3
   4.7%
Panic/Anxiety
2
   3.1%
Seizure
12
  18.8%
Hospital Visit
3
   4.7%
Withdrawal from Study
9
  14.1%
Other
9
  14.1%
3.Secondary Outcome
Title Compliance Rates of NES Seizure Diary
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: percentage of completed diary entries
90  (8)
4.Secondary Outcome
Title Trend for Auricular Acupuncture to Reduce NES Frequency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Number of Seizures per Week
Baseline 15  (16)
Treatment 13  (16)
Washout 16  (36)
Time Frame adverse event data was collected over the course of patient participation, typically 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Auricular Acupuncture
Hide Arm/Group Description 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.
All-Cause Mortality
Auricular Acupuncture
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Auricular Acupuncture
Affected / at Risk (%)
Total   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Auricular Acupuncture
Affected / at Risk (%)
Total   0/29 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward Maa
Organization: Denver Health and Hospital Authority
Phone: 303-602-5099
EMail: Edward.Maa@dhha.org
Layout table for additonal information
Responsible Party: Edward Maa, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01919307     History of Changes
Other Study ID Numbers: 12-0313
First Submitted: August 7, 2013
First Posted: August 9, 2013
Results First Submitted: March 3, 2017
Results First Posted: December 18, 2017
Last Update Posted: February 2, 2018