An Open Label, Single-site Feasibility Study of Transcranial Direct Current Stimulation (tCDS), Using the Nettle Device, for the Treatment of Chronic Migraine.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Recruitment rate
研究概览
简要总结
Migraine affects 1 in 7 people worldwide, but for those suffering from chronic migraine there is a need for safe, effective and well tolerated treatments. The Nettle device is a non-invasive device, which is worn like a headband and delivers electrical stimulation (known as transcranial direct current stimulation or TCDS) to areas of the brain known to be involved in the processing of pain. In this study, 20 patients will be trained on how to use the device and then use it daily at home for 20 minutes for three months. Patients will complete a headache diary and quality of life questionnaires before using the device, during and after. As this is a feasibility study, adherence to completing the diaries and questionnaires will be assessed. Compliance with the treatment paradigm will also be assessed.
详细描述
This study is being performed in patients with chronic migraine (CM) which represents a significant burden to both individuals, but also the healthcare system and wider economy. Pharmacological options for the treatment of migraine have expanded in recent years, however, these are not infrequently associated with side effects and are not always effective for all patients. There is an increased need for non-pharmacological treatments such as neuromodulation. Furthermore, non-invasive neuromodulation is relatively safe and, in the case of the Nettle device, can be used at home after a single training session, potentially reducing the burden on healthcare services and increasing patients' autonomy with regards to their treatment.
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation for which there is an increasing body of evidence in a number of fields including major psychiatric disorders, Parkinson's disease, post-stroke rehabilitation and epilepsy.12,13 The Nettle device, manufactured by Samphire Neuroscience, contains four electrodes, two of which provide stimulation to the primary motor cortex (M1), and two stimulate the dorsolateral prefrontal cortex (DLPFC). A treatment session consists of 2mA stimulation for 20 minutes per day. Nettle is a Class IIa medical device which has a CE mark and is currently marketed for use in dysmenorrhoea and the mood component of premenstrual syndrome. The proposed study would be the first to use Nettle in chronic migraine, therefore a small feasibility study is planned.
The research question is as follows: Is a randomised controlled trial of 12 weeks concurrent M1 and DLPFC tDCS (using the Nettle device) feasible in patients with chronic migraine, with specific regard to recruitment, adherence and monitoring?
The primary objective is: To assess the feasibility of home-based self-administration of tDCS for the preventative treatment of chronic migraine by evaluating recruitment rate, treatment adherence and diary data completeness
The secondary objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-70 years
- •Fulfil the International Classification of Headache Disorders -3 (ICHD-3) criteria for chronic migraine, diagnosed by a headache specialist, at least 1 year prior to entering the trial
- •Subject is willing to keep headache medications stable for two weeks prior to entering the study and for the duration of the study.
- •Access to a smart phone to use the mobile application to control the device and use the Headache Pro app to record headaches. A paper diary may be used instead of the Headache Pro app Id required by individual patients.
- •Subject is able to provide written informed consent prior to participation in the study
- •Females of childbearing potential agree to use an effective method of contraception from the time consent is signed until treatment discontinuation. Effective methods of contraception acceptable for this trial are the oral contraceptive pill, patch, implant, injection, ring, intra-uterine system, copper coil, barrier methods, partner vasectomy or abstinence. Participants are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal
- •If there is any possibility of pregnancy, females of childbearing potential should have a negative pregnancy test within 7 days of commencing the treatment phase.
- •Subject must be willing and able to provide written informed consent.
排除标准
- •Epilepsy or history of seizures
- •Current or planned pregnancy during the study timeframe
- •Active suicidal thoughts
- •Pre-existing neurological or neuropsychiatric condition
- •Lesion, tumour or other defect in skull or brain
- •Implant inside skill, cochlear implant or implanted hearing aid.
- •Implanted medical device e.g. pacemaker or neurostimulator
- •Use of other stimulation devices such as spinal cord stimulators, vagal nerve stimulation, auricular nerve stimulator or deep brain stimulation.
- •Concurrent medication overuse
- •Use of cranial botulinum toxin injections or CGRP inhibitors in the past 6 months
- •Current or recent (within three months) participation in another clinical trial.
- •Planned surgical or significant medical intervention during the study period which may affect the study results, at the discretion of the chief investigator.
- •Lacking mental capacity to give informed written consent.
研究组 & 干预措施
Treatment with transcranial direct current stimulation
Patients will complete three months treatment of 20 minutes daily use of the Nettle device which delivers 2mA transcranial direct current stimulation to the primary motor cortex and the dorsolateral prefrontal cortex.
干预措施: Transcranial direct current stimulation (Nettle device) 2mA stimulation for 20 minutes per day (Device)
结局指标
主要结局
Recruitment rate
时间窗: 1 year
Average number of participants enrolled per site per month
Adherence rate
时间窗: 12 weeks
defined as the proportion of schedule transcranial direct current stimulation sessions completed by each participant
Data completeness
时间窗: 12 weeks
defined as the proportion of days with a completed headache diary entry during the 12 week treatment phase
次要结局
- Headache Intensity(12 weeks)
- Adverse effects(12 weeks)
- 30% responder rate(12 weeks)
- Moderate to severe headache days(12 weeks)
- Tolerability and usability(12 weeks)
- 50% responder rate in monthly migraine days(12 weeks)
- 30% responder rate for monthly headache days(12 weeks)
- 50% responder rate for monthly headache days(12 weeks)
- Change in hospital anxiety scores(12 weeks)
- Change in hospital depression score(12 weeks)
- Change in migraine disability assessment score(12 WEEKS)
- Change in headache impact test 6 score (HIT-6)(12 weeks)
- Change in quality of life score(12 weeks)
- 30% responder rate(12 weeks)
- Moderate to severe headache days(12 weeks)
- Headache Intensity(12 weeks)
- Adverse effects(12 weeks)
- 50% responder rate in monthly migraine days(12 weeks)
- Tolerability and usability(12 weeks)
- Change in hospital depression score(12 weeks)
- Change in migraine disability assessment score(12 WEEKS)
- Change in headache impact test 6 score (HIT-6)(12 weeks)
- 30% responder rate for monthly headache days(12 weeks)
- 50% responder rate for monthly headache days(12 weeks)
- Change in hospital anxiety scores(12 weeks)
- Change in quality of life score(12 weeks)