The Effect of Transcutaneous Auricular Trigeminal Nerve Stimulation on Migraine: A Randomized Sham-Controlled, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Intensity of Headache
研究概览
简要总结
This randomized, sham-controlled, and assessor and participants-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 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 H10 device) will be assessed.
All calculations will be performed using 5-minute Polar H10 device recordings cleaned of artifacts, using Kubios HRV Premium software (Kubios Oy, Finland) in accordance with international standards.
详细描述
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.
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. 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 0 Hz and a current intensity of 0 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being aged 18-45 years,
- •being literate in Turkish
- •having been diagnosed with episodic migraine without aura by a neurologist according to the International Classification of Headache Disorders,
- •having a history of migraine for at least 6 months with at least 2 attacks per month in the last 3 months.
排除标准
- •being pregnant or breastfeeding;
- •regular use of analgesics or non-steroidal anti-inflammatory drugs for more than 15 days per month;
- •pacemaker implantation;
- •a history of addiction, syncope or abnormal ECG findings;
- •a history of intracranial haemorrhage or significant head trauma;
- •a diagnosis of epilepsy, severe anxiety or depression;
- •other types of headaches, including paresthesia or medication-overuse headaches;
- •cognitive, visual, or auditory problems that would prevent participation in the study.
研究组 & 干预措施
TaTNS group
Transcutaneus auricular trigeminal nerve stimulation A dual-channel Vagustim device (Copyright Vagustim, 2023, Vagustim Health Technologies, San Francisco, CA) is used for stimulation. In both groups, clip-on bipolar electrodes place on the upper-anterior part of the auricle.The bilateral auricular stimulation protocols: Biphasic rectangular current duration 20 minutes, current amplitude 250 microseconds, frequency 60 Hertz, current intensity increased to a maximum of 16 mA
干预措施: Transcutaneous Auricular Trigeminal Nerve Stimulation (Device)
Sham TaTNS
Sham control group:
The sham-TaTNS application will performed to mimic active TaTNS. The electrodes were placed in the same anatomical location as in the active TaTNS application. 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 will receive a current intensity of up to 0 mA.
干预措施: Sham (No Treatment) (Other)
结局指标
主要结局
Intensity of Headache
时间窗: baseline and after intervention day 1
Visual Analog Scale (0-10 cm)
Migraine Disability Assessment Scale [MIDAS])
时间窗: baseline and after intervention day 1
Migraine Disability Assessment Scale \[MIDAS\]): The MIDAS questionnaire has been shown to be reliable and valid for determining the degree of disability caused by migraine. The Turkish version of the MIDAS shown to be reliable and valid by Ertaş et al., contains 5 questions assessing disability status over the past 3 months. Patients score the number of days lost due to headache in three areas: school or paid work; housework; family, social, or leisure activities. The number of additional days with significant activity limitations (defined as at least a 50% decrease in productivity) in the paid work and household chores domains is also assessed. The MIDAS score is the sum of the scores for these five questions. Two additional questions (A and B) are not scored.
Pittsburgh Sleep Quality Index
时间窗: baseline and after intervention day 1
Pittsburgh Sleep Quality Index The validity and reliability of the Turkish version of the PSQI, developed by Buysse et al. (1989), have been demonstrated. The scale consists of a total of 24 items, 19 of which are self-reported. Five questions are answered by a spouse or roommate and are used only for clinical information, not for scoring. Item 19, which is self-reported, is also not used in room scoring. A total score \>5 indicates poor sleep quality.
次要结局
- Heart Rate Variability(baseline and after intervention day 1)
研究者
Semiha Yenişehir
Principal Investigator
Ordu University