Trial Outcomes & Findings for Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures (NCT NCT01919307)

NCT ID: NCT01919307

Last Updated: 2018-02-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: 8 Weeks
• Results posted on: 2018-02-05

Participant Flow

Participant milestones

Measure	Auricular Acupuncture 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 Study STARTED	29
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure

Auricular Acupuncture 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 Study Withdrawal by Subject

9

Baseline Characteristics

Auricular Acupuncture For The Treatment Of Non-Epileptic Seizures

Baseline characteristics by cohort

Measure	Auricular Acupuncture n=29 Participants 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.
Age, Continuous	40 years STANDARD_DEVIATION 11 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	25 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

Auricular Acupuncture n=29 Participants 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.

Completion Rate of Auricular Acupuncture in Patients With NES

15 Participants

SECONDARY outcome

Timeframe: 16 Weeks

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

Outcome measures

Measure	Auricular Acupuncture n=64 Adverse Events 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.
Adverse Events Headache	6 Adverse Events
Adverse Events Pain/Tenderness	9 Adverse Events
Adverse Events Skin Irritation	1 Adverse Events
Adverse Events Weakness	1 Adverse Events
Adverse Events Sleepiness	3 Adverse Events
Adverse Events Nausea	5 Adverse Events
Adverse Events Dizziness	4 Adverse Events
Adverse Events Panic/Anxiety	2 Adverse Events
Adverse Events Seizure	12 Adverse Events
Adverse Events Hospital Visit	3 Adverse Events
Adverse Events Withdrawal from Study	9 Adverse Events
Adverse Events Other	9 Adverse Events

SECONDARY outcome

Timeframe: 16 Weeks

For each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.

Outcome measures

Measure

Auricular Acupuncture n=29 Participants 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.

Compliance Rates of NES Seizure Diary

90 percentage of completed diary entries Standard Deviation 8

SECONDARY outcome

Timeframe: 16 weeks

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)

Outcome measures

Measure	Auricular Acupuncture n=20 Participants 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.
Trend for Auricular Acupuncture to Reduce NES Frequency Baseline	15 Number of Seizures per Week Standard Deviation 16
Trend for Auricular Acupuncture to Reduce NES Frequency Treatment	13 Number of Seizures per Week Standard Deviation 16
Trend for Auricular Acupuncture to Reduce NES Frequency Washout	16 Number of Seizures per Week Standard Deviation 36

Adverse Events

Auricular Acupuncture

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward Maa

Denver Health and Hospital Authority

Phone: 303-602-5099

Email: Edward.Maa@dhha.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place