Effect of Transcranial Alternating Current Stimulation in Chronic Low Back Pain: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Heart Rate Variability Before and After 40-minute Stimulation
研究概览
简要总结
Chronic pain is a severe disabling problem within society, affecting 25-30% of the United States population.. Transcranial alternating current stimulation (tACS) has the potential to provide a treatment option that is safe, scientifically-supported, low-cost, and easy-to-administer method to effectively reduce symptoms in patients suffering from chronic pain. The purpose of this study is to test the feasibility of using tACS to treat patients with chronic pain, and to collect pilot efficacy as well as EEG and EKG biomarker data for optimizing the design of subsequent large-scale studies. The treatment rationale is to renormalize the presumed pathological structure of alpha oscillations in the prefrontal cortex (PFC) of patients with chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
This is a double-blind study, meaning that neither the participant nor the experimenter knows what kind of stimulation the participant is receiving. An unblinded monitor (separate from the staff that interacts with the participant) is responsible for creating the stimulation codes that run each session and for ensuring that these codes worked correctly.
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
- •Male or female, aged 18-65
- •Diagnosed with nonspecific chronic low back pain by clinician
- •BMI is less than 30
- •Suffered from chronic pain for > 6 months
- •Self-report pain measures >4
- •Meets criteria for low depression and suicide risk as defined by the Hamilton-Depression Rating Scale
- •Capacity to understand all relevant risks and potential benefits of the study (informed consent)
- •Not currently taking opioids, benzodiazepines, and anticonvulsant medications
排除标准
- •Radicular Pain
- •Traumatic brain injury, Any brain devices/implants, including cochlear implants and aneurysm clips
- •History of major neurological or psychiatric illness, including epilepsy
- •(For females) Pregnancy or breast feeding
- •Diagnosis of eating disorder (current or within the past 6 months), Obsessive Compulsive Disorder (lifetime), or Attention-Deficit Hyperactivity Disorder (currently under treatment)
研究组 & 干预措施
Sham tACS
Sham Stimulation mimics the physical effects of stimulation, with up to one minute of stimulation during the session. Sham stimulation is delivered using the XCSITE100 Stimulator Sham.
干预措施: XCSITE100 Stimulator Sham (Device)
Active 10 Hz tACS
Participants will receive 2mA of alternating current stimulation at a frequency of 10Hz for 40 minutes. tACS stimulation is delivered using the XCSITE100 Stimulator tACS.
干预措施: XCSITE100 Stimulator tACS (Device)
结局指标
主要结局
Change in Heart Rate Variability Before and After 40-minute Stimulation
时间窗: before and after 40-minute stimulation at each session
Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation
Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation
时间窗: 5 minute recordings before and after each 40-minute stimulation at each session.
Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation
次要结局
- Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation(before and after 40 minute stimulation session)