NCT02497196已完成不适用
Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Signal Coherence and EEG power as measured Quantitative Electroencephalographic Analysis (qEEG):
研究概览
简要总结
This study investigates comparing the effects of transcranial Pulsed Current Stimulation and transcranial Direct Current Stimulation (tDCS) (Soterix ©) and their combination on neurophysiological outcomes on healthy subjects as well as on the clinical population for chronic visceral pain. The study also aims to evaluate the effects of these techniques on pain thresholds in healthy subjects as well as for chronic visceral pain patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PART 1: 48 healthy subjects will be selected to take part in this study. All healthy subjects will need to meet all of the following inclusion criteria and none of the following
排除标准
- •Inclusion criteria:
- •Provide informed consent to participate in the study
- •Age 18 - 60 years
- •Exclusion criteria:
- •History of alcohol or substance abuse within the last 6 months as self-reported
- •Severe depression (with a score of >30 in the Beck Depression Inventory)*
- •History of seizures during the last two years or diagnosis of epilepsy
- •History of neurological or psychiatric illness
- •Unstable medical conditions such as uncontrolled diabetes mellitus, uncompensated cardiac pathology, heart failure, kidney insufficiency or chronic obstructive pulmonary disease, acute thrombosis
- •History of head injury resulting in more than a momentary loss of consciousness during the last two years
- •History of unexplained fainting spells or loss of consciousness as self-reported during the last two years
- •Contraindication to tPCS or tDCS
- •Metallic brain implants
- •Implanted brain electronic medical devices
- •Pregnancy
- •Use of neuropsychotropic drugs within the past two weeks as self reported
- •Part 2: 18 patients with Chronic Visceral Pain will take part in this experiment. All subjects must meet the following criteria:
- •Inclusion criteria:
- •Provide informed consent to participate in the study
- •Age 18 - 60 years
- •Abdominal or pelvic pain for ≥ 3 days per week for at least 3 months (average VAS scale score of 4/10 or greater at time of enrollment) as self reported
- •Diagnosis of chronic visceral pain (e.g. Chronic Pancreatitis or Chronic Pelvic Pain) as confirmed by medical records or a letter from their physician
- •If taking pain medications, stable doses are required for at two weeks prior to initiation of the study
- •Exclusion criteria:
- •History of alcohol or substance abuse within the last 6 months as self-reported
- •Severe depression (with a score of >30 in the Beck Depression Inventory)*
- •Unstable medical conditions such as uncontrolled diabetes mellitus, uncompensated cardiac pathology, heart failure, kidney insufficiency or chronic obstructive pulmonary disease, acute thrombosis
- •History of head injury resulting in more than a momentary loss of consciousness during the last two years
- •History of unexplained fainting spells or loss of consciousness as self-reported during the last two years
- •Contraindication to tPCS or tDCS
- •Metallic brain implants
- •Implanted brain electronic medical devices
- •Pregnancy or trying to become pregnant during the next month
- •Use of carbamazepine oxcarbazepine, phenytoin, pramipexole (Mirapex), or cavergoline (Dostinex) within the past 6 months as self-reported
结局指标
主要结局
Signal Coherence and EEG power as measured Quantitative Electroencephalographic Analysis (qEEG):
时间窗: For the healthy subjects during their 1-time study visit; For visceral pain patients, it will be measured over the course of about 3 weeks
The EEG test is performed to measure the electrical activity in the brain and to examine the dynamic changes.
次要结局
- Depression level as measured Beck Depression Inventory (BDI)(Done for both healthy and visceral pain subjects during screening (first study visit))
- Effectiveness of blinding as measured by the tPCS and tDCS Blinding Questionnaire(For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks)
- Side-effects from stimulation as measured by the tDCS and tPCS Side Effects Questionnaire(For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks)
- Pain levels and medication intake as measured Pain/Medication Diary(Only done for visceral pain subjects; it will be measured over the course of about 3 weeks)
- Sensitivity of Filaments as measured by Von Frey assessment(Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.)
- Mood scores as measured Visual Analog Mood Scale (VAMS)(Only done for visceral pain subjects; it will be measured over the course of about 3 weeks)
- Pressure Values as measured by Pain Pressure Test (PPT) for Conditioned Pain Modulation (CPM)(For the healthy subjects during their 1-time study visit; For visceral pain subjects, it will be measured over the course of about 3 weeks)
- Pain score as measured by Visual Analogue Scale (VAS) for Pain:(Only done for visceral pain subjects; it will be measured over the course of about 3 weeks.)
研究者
Felipe Fregni
Prinicipal Investigator
Spaulding Rehabilitation Hospital
研究点 (2)
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