Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:59 PM
Study NCT ID:
NCT07457268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine
Sponsor:
Ordu University
Organization:
Study Overview
Official Title:
The Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine: A Randomized Sham-Controlled, Double-Blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized, sham-controlled, and double-blind clinical study aims to investigate the effects of transcutaneous auricular trigeminal nerve stimulation (taTNS) on intensity of headache, sleep quality, level of disability, and Heart rate variability (HRV) in patients with migraine.
The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders, (4) having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months. The exclusion criteria were: (1) being pregnant or breastfeeding; (2) regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month; (3) pacemaker implantation; (4) a history of addiction, syncope or abnormal ECG findings; (5) a history of intracranial haemorrhage or significant head trauma; (6) a diagnosis of epilepsy, severe anxiety or depression; (7) other types of headaches, including paresthesia or medication-overuse headaches; and (8) cognitive, visual, or auditory problems that would prevent participation in the study.
The TaTNS was applied to the intervention and control (sham) groups by a physiotherapist (AP). The treatment session lasted 20 minutes and will apply three days a week for 12 weeks.
The physical (age, gender, height, body weight), sociodemographic (marital status, education level), and clinical characteristics (chronic diseases, medications used, age of migraine onset, migraine frequency in the last month, migraine treatment history) of participants will be recorded.
Primary outcome measurement: Migraine headache intensity (VAS), disability level (Migraine Disability Assessment Scale \[MIDAS\]), sleep quality (Pittsburgh Sleep Quality Index \[PSQI\]), Secondary outcome measurement: Heart rate variability (HRV) (Polar H7 device) will be assessed.
All calculations will be performed using 5-minute Polar H7 recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.
The inclusion criteria were: (1) being aged 18-45 years, (2) being literate in Turkish, (3) having been diagnosed with episodic migraine with aura and migraine without aura by a neurologist according to the International Classification of Headache Disorders, (4) having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months. The exclusion criteria were: (1) being pregnant or breastfeeding; (2) regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month; (3) pacemaker implantation; (4) a history of addiction, syncope or abnormal ECG findings; (5) a history of intracranial haemorrhage or significant head trauma; (6) a diagnosis of epilepsy, severe anxiety or depression; (7) other types of headaches, including paresthesia or medication-overuse headaches; and (8) cognitive, visual, or auditory problems that would prevent participation in the study.
The TaTNS was applied to the intervention and control (sham) groups by a physiotherapist (AP). The treatment session lasted 20 minutes and will apply three days a week for 12 weeks.
The physical (age, gender, height, body weight), sociodemographic (marital status, education level), and clinical characteristics (chronic diseases, medications used, age of migraine onset, migraine frequency in the last month, migraine treatment history) of participants will be recorded.
Primary outcome measurement: Migraine headache intensity (VAS), disability level (Migraine Disability Assessment Scale \[MIDAS\]), sleep quality (Pittsburgh Sleep Quality Index \[PSQI\]), Secondary outcome measurement: Heart rate variability (HRV) (Polar H7 device) will be assessed.
All calculations will be performed using 5-minute Polar H7 recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.
Detailed Description:
The participants with migraine headache will be randomly assigned to the two groups (TaTNS and sham TaTNS) in equal numbers using software (https://www.randomizer.org/).
The TaTNS will be applied to the intervention and control (sham) groups by a physiotherapist (AP). The intervention will be applied three days a week for 12 weeks, with 20 minutes session duration.
A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) will be used for stimulation. In both groups, clip-on bipolar electrodes were placed on the upper-anterior part of the auricle. The bilateral auricular stimulation protocols as follows: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA.
Sham TaTNS The sham-TaTNS application was performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation was applied at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve.
The sham group received a frequency of 1 Hz and a current intensity of up to 1 mA.
To assess the success rate of the blinding technique, at the end of the treatment period, each participant was asked to guess which treatment group they belonged to. Additionally, level of confidence in their guesses regarding the groups they belonged to was assessed using the Visual Analog Scale (VAS) (0-10 cm).
The TaTNS will be applied to the intervention and control (sham) groups by a physiotherapist (AP). The intervention will be applied three days a week for 12 weeks, with 20 minutes session duration.
A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) will be used for stimulation. In both groups, clip-on bipolar electrodes were placed on the upper-anterior part of the auricle. The bilateral auricular stimulation protocols as follows: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA.
Sham TaTNS The sham-TaTNS application was performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application, but stimulation was applied at a very low intensity (below the sensory threshold, 1 mA) that would not produce a neuromodulatory effect, or only a brief stimulation was applied at the beginning to create a temporary sensation on the skin. This method provides an experience similar to the active application in terms of participants' perception of stimulation, but does not create effective physiological stimulation in the trigeminal nerve.
The sham group received a frequency of 1 Hz and a current intensity of up to 1 mA.
To assess the success rate of the blinding technique, at the end of the treatment period, each participant was asked to guess which treatment group they belonged to. Additionally, level of confidence in their guesses regarding the groups they belonged to was assessed using the Visual Analog Scale (VAS) (0-10 cm).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: