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The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Elexir (trigeminal nerve electrical stimulator)
Sponsored by
Nu Eyne Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women over 19 years old
  • Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
  • Patients with history of migraine more than 1 year
  • Patients who have headaches at least twice a month
  • Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
  • A person who voluntarily agreed to participate in this clinical trial

Exclusion Criteria:

  • Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
  • Those who are diagnosed with medication overuse headache in addition to migraine headaches
  • Pregnant or lactating of women within 6months
  • Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. *Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
  • Patients with mental illness who can interfere with their participation in the study.
  • In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation.
  • Patients with a history of drug or alcohol abuse
  • Those who participated in other clinical trials within 30 days of screening.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.

Outcomes

Primary Outcome Measures

Change in the number of days of moderate to severe headache
Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline

Secondary Outcome Measures

Change in the number of headache days
Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline
Change in the frequency of headache days
Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline
Change in the frequency of taking the acute phase drug
Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline
Change in pain intensity when headache occurs
Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline
Change in the headache effect assessment (HIT-6) score
Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline
Change in the migraine-related quality of life (MSQ 2.1) score
Check the migraine-related quality of life (MSQ 2.1) change in 4 weeks after the start of stimulation compared to the baseline MSQ 2.1 measures the impact of migraine across three essential aspects. The MSQ total and scale score varies between 0 and 100 with higher scores indicating higher impact.

Full Information

First Posted
March 21, 2022
Last Updated
March 30, 2022
Sponsor
Nu Eyne Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05301920
Brief Title
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine
Official Title
A Single-center, Open-label, Clinical Effect Observational Study to Evaluate the Safety and Effectiveness of Reducing the Frequency of Migraine Onset Through Clinical Application of Elexir (Trigeminal Nerve Electrical Stimulator) in Migraine Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
January 28, 2022 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nu Eyne Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.
Detailed Description
Duration of study period (per participant): Screening period (-6~0weeks), Intervention period (4weeks). Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit. The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time. During the study period, examination and treatment methods are carried out in the same way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
N=20 60Hz pulse electrical stimulation The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
Intervention Type
Device
Intervention Name(s)
Elexir (trigeminal nerve electrical stimulator)
Intervention Description
Elexir performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
Primary Outcome Measure Information:
Title
Change in the number of days of moderate to severe headache
Description
Check the number of days of moderate to severe headache at 4 weeks after start compared to baseline
Time Frame
baseline, 4 weeks
Secondary Outcome Measure Information:
Title
Change in the number of headache days
Description
Check the number of headache days in 4 weeks after the start of stimulation compared to the baseline
Time Frame
baseline, 4 weeks
Title
Change in the frequency of headache days
Description
Check the frequency of headache days in 4 weeks after the start of stimulation compared to the baseline
Time Frame
baseline, 4 weeks
Title
Change in the frequency of taking the acute phase drug
Description
Check the frequency of taking the acute phase drug in 4 weeks after the start of stimulation compared to the baseline
Time Frame
baseline, 4 weeks
Title
Change in pain intensity when headache occurs
Description
Check the change in pain intensity when headache occurs in 4 weeks after the start of stimulation compared to the baseline
Time Frame
baseline, 4 weeks
Title
Change in the headache effect assessment (HIT-6) score
Description
Check the change in the headache effect assessment (HIT-6) in 4 weeks after the start of stimulation compared to the baseline
Time Frame
baseline, 4 weeks
Title
Change in the migraine-related quality of life (MSQ 2.1) score
Description
Check the migraine-related quality of life (MSQ 2.1) change in 4 weeks after the start of stimulation compared to the baseline MSQ 2.1 measures the impact of migraine across three essential aspects. The MSQ total and scale score varies between 0 and 100 with higher scores indicating higher impact.
Time Frame
baseline, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over 19 years old Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2 Patients with history of migraine more than 1 year Patients who have headaches at least twice a month Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs A person who voluntarily agreed to participate in this clinical trial Exclusion Criteria: Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches Those who are diagnosed with medication overuse headache in addition to migraine headaches Pregnant or lactating of women within 6months Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. *Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc Patients with mental illness who can interfere with their participation in the study. In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation. Patients with a history of drug or alcohol abuse Those who participated in other clinical trials within 30 days of screening.
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine

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