Noninvasive Brain Stimulation for Treating Carpal Tunnel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Visual Analogue Score (VAS)
研究概览
简要总结
The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain in subjects with Carpal Tunnel Syndrome. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.
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
- 18 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 18 to 80 years old
- •Having symptomatic CTS spreading within or beyond the median nerve distribution (demonstrating 'extra-median spread'), involving at least 1 wrist, with chronic pain as defined by International Association for the Study of Pain (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 3 on a 0-10 VAS scale).
- •Pain resistant to first line therapies of chronic pain (pain still present at lower levels most of the time following therapy)
- •Must have the ability to feel pain as self-reported.
排除标准
- •Subject is pregnant
- •Contraindications to tDCS+TUS:
- •intracranial metal implant
- •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 major depression (with a PHQ-9 score of ≥20)
- •History of neurological disorders involving stroke, brain tumors, or epilepsy with residual neurological symptoms as self-reported (note patients will also be evaluated via EEG at baseline about 1 week prior to stimulation and any patient showing abnormal EEG activity will be removed))
- •History of unexplained fainting spells as self-reported
- •History of head injury resulting in more than a momentary loss of consciousness as self-reported and with current neurological deficits
- •History of intracranial neurosurgery as self-reported
研究组 & 干预措施
Sham tDCS + Sham TUS
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: transcranial Direct Current Stimulation (tDCS) (Device)
Sham tDCS + Sham TUS
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: Transcranial Ultrasound (TUS) (Device)
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: transcranial Direct Current Stimulation (tDCS) (Device)
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: Transcranial Ultrasound (TUS) (Device)
结局指标
主要结局
Visual Analogue Score (VAS)
时间窗: 9 weeks
Changes in the Visual Analogue Scale (VAS) for pain will be measured in order to determine whether anodal transcranial direct current stimulation in conjunction with transcranial ultrasound is effective in reducing pain in subjects with Carpal Tunnel Syndrome. The VAS scale goes from 0 up to 10, where 0 means no pain at all and 10 means the worst imaginable pain.
次要结局
- Visual Analog Mood Scale (VAMS)(Measured for approximately for a total 9 weeks)
- Temporal Summation (TS)(Measured for approximately for a total 9 weeks)
- Conditioned pain modulation (CPM)(Measured for approximately for a total 9 weeks)
- Vibration Detection Threshold (VDT)(Measured for approximately for a total 9 weeks)
- Michigan Hand Outcomes Questionnaire (MHQ)(Measured for approximately for a total 9 weeks)
- The Medical Outcomes Study 36-Item Short Form (SF-36)(Measured for approximately for a total 9 weeks)
- Montreal Cognitive Assessment (MOCA)(Measured for approximately for a total 9 weeks)
- Patient Health Questionnaire (PHQ-9)(Measured for approximately for a total 9 weeks)
- Multidimensional Pain Inventory (MPI)(Measured for approximately for a total 9 weeks)
- Verbal Rating Scale (VRS)(Measured for approximately for a total 9 weeks)
- tDCS Side Effects Questionnaire(Measured for approximately for a total 9 weeks)
- Boston Carpal Tunnel Questionnaire(Measured for approximately for a total 9 weeks)
- Neuropathic Pain Symptom Inventory (NPSI)(Measured for approximately for a total 9 weeks)
- Strength (grip and pinch)(Measured for approximately for a total 9 weeks)
- Electroencephalography (EEG)(Measured for approximately for a total 3 weeks)
- Range of Motion (ROM)(Measured for approximately for a total 9 weeks)
- Wrist Flexion-Extension:(Measured for approximately for a total 9 weeks)
- Thumb Reaching Test(Measured for approximately for a total 9 weeks)
- Reach to Pinch(Measured for approximately for a total 9 weeks)
研究者
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital