tDCS for the Management of Chronic Visceral Pain in Patients With Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
This study is testing whether the addition of a noninvasive form of brain stimulation called transcranial direct current stimulation (tDCS) when combined with meditation helps decrease the abdominal pain in patients with chronic pancreatitis. The device involved in this study, transcranial direct current stimulation (tDCS) is investigational. This means that the study device is still being tested in research studies and is not approved by the Food and Drug Administration [FDA].
详细描述
This is a double-blind, pilot study with the goal of testing the effects of tDCS coupled with meditation in the management of visceral pain in patients with chronic pancreatitis. We will enroll a total of 14 subjects with chronic pancreatitis. After enrollment, subjects will be randomized to active stimulation plus mediation (7 subjects) or sham stimulation plus meditation (7 subjects). Subjects will undergo 5 days of active tDCS stimulation plus meditation or sham tDCS plus meditation. Sessions will last approximately 30 min - 1 hour. EEG activity will be measured in the first, last and follow-up visits. After each stimulation session, we will assess for adverse effects using the tDCS adverse effects questionnaire. We will also have the subject fill out a pain/medication diary during the 5 days of treatment. All study procedures will be completed at BIDMC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide informed consent to participate in the study
- •18 years old
- •If taking pain medications, stable doses are required for at least 1 month prior to initiation of the study
排除标准
- •History of alcohol or substance abuse within the last 6 months as self-reported
- •Suffering from severe depression (with a score of >30 in the Beck Depression Inventory)
- •Diagnosis of any neurological diseases (such as epilepsy)
- •Episodes of seizures within the last 6 months
- •Unexplained loss of consciousness
- •Use of carbamazepine or neuropsychotropic drugs
- •Have had no neurosurgery as self reported
- •Contraindications to tDCS
- •Metal in the head
- •Implanted brain medical devices
- •Pregnant at time of enrollment
- •Previous experience with meditation
结局指标
主要结局
Pain
时间窗: Two weeks
Assess the effects of 5 days of active vs sham tDCS stimulation plus meditation on chronic visceral pain in patients with chronic pancreatitis. We will determine the magnitude of pain reduction using the Visual Analog Scale (VAS) score and Brief Pain Inventory (BPI). We hypothesize that active tDCS plus meditation will have a greater decrease in VAS scores and BPI scores when compared to sham tDCS plus meditation in subjects with chronic pancreatitis
次要结局
- Quality of Life(Two weeks)
研究者
Steven Freedman
MD PhD Professor of Medicine Harvard Medical School
Beth Israel Deaconess Medical Center