A Randomized, Double-blind Sham-controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety in Adolescents - The Modius Calm Adolescent Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The change in GAD-7 score from baseline to 4 weeks
研究概览
简要总结
Trial title: A Randomized, Double-blind Sham-controlled Clinical Trial to Evaluate The Efficacy of Electrical Vestibular Stimulation (VeNS), Compared to a Sham Control For The Management Of Anxiety in Adolescents - The Modius Calm Adolescent Study
The aim of this study: This investigation aims to evaluate the effects of VeNS for the treatment of Generalized Anxiety Disorder, to contribute to the field of knowledge about the neurological mechanisms to determine whether the relatively inexpensive, and non-invasive technique of VeNS can reduce the severity of GAD symptoms in adolescents.
Allocation: Randomized to either active device or control device usage.
Endpoint classification: Efficacy Study
Intervention Model: Parallel Assignment in 1:1 active to control allocation
Sample size: The aim is to recruit a total of up to 60 participants. The study will last 12 weeks in total for each subject.
详细描述
This double blind randomized controlled trial will enroll up to 60 subjects and will be conducted at the BGS MCH Hospital. The study will be randomized for a 8-week period with a 1:1 active to sham device allocation. Each participant will complete 5 stimulation sessions per week under the supervision of a researcher at the clinic. Each session will be 30 minutes on the day of usage. The scheduled study events are to be undertaken at the following timepoints:
- Baseline: Study Visit 1 (0-week timepoint for enrolment)
- Study Visit 2 (2-week timepoint)
- End of Study (4-week timepoint)
- Post-intervention follow-up at 2 weeks (6-week timepoint)
- Post-intervention follow-up at 6 weeks (10-week timepoint)
- Post-intervention follow-up at 8 weeks (12-week timepoint)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •Signed Assent Form
- •Male or female, age ≥ 12 years and ≤ 17 years at the time of signing informed consent
- •GAD-7 score of >/=10 at screening
- •Can speak and read English
- •Ability and willingness to travel to the clinic to complete all study visits, stimulation sessions and procedures
- •Ability and willingness to adhere to 30 minutes usage of the device 5 days per week for the duration of the trial at clinic
- •Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact anxiety e.g. dietary or exercise changes
排除标准
- •GAD-7 score of < 10 at screening
- •Medication for anxiety
- •Starting a new antidepressant during the study, or on an unstable dose of antidepressants within 3 months of starting study
- •Risk of persistent self-harm or suicide
- •Diagnosis or history of bipolar disorder
- •History of a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
- •Diagnosis of substance use disorder or dependence
- •Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
- •History of diagnosed cognitive impairment / disorder such as delirium or dementia
- •Previous diagnosis of a chronic viral infection, for example hepatitis or HIV.
- •History of stroke or head injury requiring intensive care or neurosurgery
- •Presence of permanently implanted battery-powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
- •History of epilepsy
- •History of severe tinnitus or vertigo
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
- •History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- •History of vestibular dysfunction or another inner ear disease
- •Regular use (more than twice a month) of antihistamine medication within the last 6 months
- •Diagnosis of active migraines
- •Previous use of Modius device or any VeNS device
- •Participation in other clinical trials sponsored by Neurovalens
- •Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
- •Failure to use device daily during trial participation (no more than 7 consecutive days usage drop without reasonable explanation)
研究组 & 干预措施
Active VeNS device
The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
干预措施: Modius Calm (Device)
Sham device
The sham device looks identical to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
干预措施: Sham device (Device)
结局指标
主要结局
The change in GAD-7 score from baseline to 4 weeks
时间窗: The GAD-7 shall be completed at baseline, 4 weeks (end of intervention) and 2 weeks, 6 weeks and 8 weeks post intervention .
Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points. The GAD-7 items include: 1) nervousness; 2) inability to stop worrying; 3) excessive worry; 4) restlessness; 5) difficulty in relaxing; 6) easy irritation; and 7 fear of something awful happening. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. The GAD-7 was originally validated in a primary care sample and a cut-off score of 10 had a sensitivity value of 0.89 and a specificity value of 0.82 for identifying GAD.
次要结局
- Change in the Insomnia Severity Index (ISI) score from baseline to 4 weeks(The ISI shall be completed at baseline and repeated at both 2 (mid-point) and 4 weeks (end of study).)
- Change in the Mental Health-related Quality of Life (SF-36) mental component (MC) score from baseline to 4 weeks(The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).)
- Change in the Physical Health-related Quality of Life (SF-36) physical component (MC) score from baseline to 4 weeks.(The SF-36 will be administered at baseline, mid-point (2 weeks), and end of study (4 weeks).)