Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent side effects measured with the NSEC
研究概览
简要总结
This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).
- The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.
- The secondary objective will be to monitor changes in GAD symptom severity throughout the study.
Results from this study will inform a randomized controlled trial to be conducted in the future.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) criteria for generalized anxiety disorder.
- •Subjects on a stable dose of an selective serotonin reuptake inhibitor (SSRI) or serotonin and noradrenaline reuptake inhibitor (SNRI) for at least 8 weeks.
- •Treatment-resistant - treatment resistance will be defined as lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD. Only trials lasting at least 8 weeks, and with at least the minimum effective dose of the given medication will be considered failed trials.
排除标准
- •Moderate to severe major depressive disorder
- •Moderate to high suicidality
- •Diagnosis of obsessive compulsive disorder (OCD), PTSD, bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities and dementia or other neurological diseases including trigeminal neuralgia
- •Pregnant or breastfeeding women
- •Participants who are experiencing seizures
- •Implanted vagal nerve stimulation (VNS) or other electrical devices
- •Participants who are already undergoing transcutaneous electrical nerve stimulation
- •Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week
- •Consumption of natural health products that may affect anxiety or depression symptoms
研究组 & 干预措施
Active stimulation
Trigeminal nerve stimulation will occur by placement of electrodes (1.25" silver electrodes Bio-Flex BF4, Biotens/Vermed, Buffalo, New York, USA) bilaterally on the V1 branches of the trigeminal nerve (CNV) located on the forehead. Current will be generated from the EMS 7500 stimulator (TENS Products, Inc., Granby, CO) (Class II medical device) and will be set to a level that is clearly perceptible by each patient (i.e. tingling sensation) but not uncomfortable or painful. Current level will be determined for each patient at baseline and will likely be between 4-6 milliampere (mA). Active stimulation will occur at 120 Hz with a 250 μs pulse width and with a duty cycle of 30 seconds on to 30 seconds off.
干预措施: Trigeminal Nerve Stimulation (Device)
结局指标
主要结局
Incidence of treatment-emergent side effects measured with the NSEC
时间窗: Baseline visit, 4-week visit and 8-week visit.
Monitor participants for minor treatment-emergent side effects measured with the Neurostimulation Side-Effect Checklist (NSEC). NSEC is a list of 31 possible side effects from neurostimulation or from antidepressants. Each item is rated from 0 (absent) to 3 (severe).
Incidence of treatment-emergent adverse events
时间窗: Throughout the study, 8 weeks
Monitor participants for treatment-emergent adverse events and serious adverse events.
Response to treatment defined by CGI-I score below 3
时间窗: 4-week visit and 8-week visit.
Response to treatment, which will be defined as a score of 1 or 2 on the Clinical Global Impression - Improvement (CGI-I) scale. CGI-I is a clinician administered one-item clinical scale rated from 1 (very much improved) to 7 (very much worse). Not assessed would confer score 0.
次要结局
- Change in anxiety severity measured by CGI-S(Baseline visit, 4-week visit and 8-week visit.)
- Remission defined by CGI-S score below 3(4-week visit and 8-week visit.)
- Change of anxiety symptoms measured with GAD-7(Baseline visit, 4-week visit and 8-week visit.)
- Change of anxiety symptoms measured with BAI(Baseline visit, 4-week visit and 8-week visit.)
- Change of anxiety symptoms measured with PSWQ(Baseline visit, 4-week visit and 8-week visit.)
研究者
Dr. Rafael Freire
Associate Professor, Department of Psychiatry
Kingston Health Sciences Centre