Optimization of Non-Invasive Brain Stimulation for Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Changes in pain as measured by the Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study is to assess the effects of Transcranial Direct Current Stimulation (tDCS) in combination with Transcranial ultrasound (TUS) for the treatment of pain and functional limitations in subjects with Diabetic Neuropathic Pain.
详细描述
Active stimulation will be compared with compared to SHAM stimulation in DNP patients.
20 DNP patients, 10 per group, receive stimulation or sham for 5 consecutive days, 20 min/day, followed by 2, 4, and 6 weeks post-therapy. 9 visits plus screening/baseline (total 10 visits).
Subsequently, 40 DNP patients will be enrolled, 20 per group, giving 5 consecutive days, 20 min/day, followed by 2 weeks of bi-weekly stimulation or sham for 20 min/day (total stimulations n=9) and follow-ups at 2, 4, 6, & 8 weeks post-stim): 13 visits plus screening/ baseline (total 14 visits).
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent to participate in the study.
- •Subjects between 40 to 80 years old.
- •Having diabetic neuropathic pain, involving at least 1 foot, with existing pain for at least 6 months, and having pain on at least half the days in the past 6 months with an average of at least a 4 on a 0-10 VAS scale).
- •Having pain resistant to common analgesics and medications for first-line therapy of chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, Codeine, etc.
- •Must have the ability to feel pain as self-reported.
排除标准
- •Subject is pregnant.
- •Contraindications to tDCS in conjunction with TUS, i.e. metallic implant in the brain or implanted brain medical devices
- •History of alcohol or drug abuse within the past 6 months as self-reported.
- •Use of carbamazepine within the past 6 months as self-reported.
- •Suffering from severe depression (with a PHQ 9 score of ≥ 10).
- •History of neurological disorders as self-reported.
- •History of unexplained fainting spells as self-reported.
- •History of severe head injury resulting in more than a momentary loss of consciousness as self-reported.
- •History of neurosurgery as self-reported.
- •Unstable pain (defined as pain intensities that vary by more than 4 points on 0-10 VAS scale over the 1-week period of trial run-in).
研究组 & 干预措施
Sham
Subjects in the sham group will undergo 20 minutes of sham transcranial direct current stimulation (tDCS) and sham transcranial ultrasound (TUS).
干预措施: Sham (Device)
Active Comparator: Active tDCS + Active TUS
Subjects in the experimental group will undergo 20 minutes of active transcranial direct current stimulation (tDCS) and active transcranial ultrasound (TUS).
干预措施: Active Comparator: Active tDCS + Active TUS (Device)
结局指标
主要结局
Changes in pain as measured by the Visual Analog Scale (VAS)
时间窗: Measured for approximately 3 months
The scale will assess a patient's pain intensity on a scale from 0 (no pain) to 10 (worst pain imaginable). Changes in VAS for Pain will be measured to determine whether anodal transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) (applied in a diagnostic mode) is effective in reducing pain of subjects with diabetic neuropathic pain.
次要结局
- Changes in the Verbal Rating Scale (VRS) for Pain(Measured for approximately 3 months)
- Electroencephalography(Measured for approximately 3 months)
- Patient Health Questionnaire (PHQ-9)(Measured for approximately 3 months)
- Multidimensional Pain Inventory (MPI)(Measured for approximately 3 months)
- Changes in Conditional Pain Modulation(Measured for approximately 3 months)
- Montreal Cognitive Assessment(Measured for approximately 3 months)
- N-back tests(Measured for approximately 3 months)
- Functional reach test(Measured for approximately 3 months)
- American Pain Foundation Pain and Medication Diary(Measured for approximately 3 months)
- Brief Pain Inventory-DPN(Measured for approximately 3 months)
- Adverse events(Measured for approximately 3 months)
- Changes in Visual Analog Scalefor Mood (VAMS)(Measured for approximately 3 months)
- Study 36-Item Short Form (SF-36)(Measured for approximately 3 months)
- 4-choice reaction time(Measured for approximately 3 months)
- Walking test(Measured for approximately 3 months)
研究者
Ciro Ramos Estebanez, MD., Ph.D.
Neurology faculty
Case Western Reserve University