The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To Complex Regional Pain Syndrome (CRPS) or Diabetic Neuropathy-A PILOT, DOUBLE-BLIND, SHAM-CONTROLLED, CROSS-OVER STUDY
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes in the amplitude of P300
研究概览
简要总结
This is a controlled trial designed to determine short- and long-term effects of repeated tDCS on the P300 component of event-related evoked potentials in patients with chronic neuropathic pain due to Complex regional Pain Syndrome (CRPS) or diabetic neuropathy as compared with healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •An affected upper limb or lower limb
- •Diagnosed as : Diabetic neuropathy, Complex Regional Pain Syndrome (CRPS), Chemotherapy Induced Pain Neuropathy (CIPN), Peripheral Neuropathy.
- •Have not responded to at least two medications of the following groups: Opioids. Tricyclics, SSRI, SNRI, Pregabalin, Gabapentin, Anticonvulsants.
- •Positive LANSS or CRPS criteria as follows:
- •Continuing pain which is disproportionate to any inciting event or for CRPS diagnosis.
- •Must report at least one symptom (symptoms here are reports by subject) in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic.
- •Must display at least one sign (signs here refer to objective observation/testing) in in each of the four following categories: sensory, vasomotor, sudomotor/edema, motor/trophic;
- •Must meet resistant neuropathic pain criteria - pain that is neuropathic in characters that at least two neuropathic medications not from the same group have been tried for at least a month without improvement or severe side-effects were experienced. Resistant neuropathic pain with a score for "average pain in the last 24 hours" ≥4 on a numeric scale 0-10
- •tDCS naive
排除标准
- •Serious health problems other than CRPS or resistant neuropathic pain (e.g. uncontrolled hypertension, uncontrolled diabetes, heart failure)
- •Pain/painful conditions unrelated to CRPS or neuropathic pain
- •Pregnancy
- •History of seizures/epilepsy
- •Implanted device (e.g. pacemaker)
- •Active illicit drug/alcohol abuse
- •Unable to follow directions or complete tools in Hebrew
- •Previous exposure to tDCS stimulation
研究组 & 干预措施
1-CRPS
10 tDCS naïve patients with CRPS-related neuropathic pain in upper limb
干预措施: TDCS/sham procedure on five consecutive days (Device)
2-DN
20 tDCS naïve patients with diabetic neuropathy
干预措施: TDCS/sham procedure on five consecutive days (Device)
3-RPNP
20 tDCS naïve patients with resistant peripheral neuropathic pain
干预措施: TDCS/sham procedure on five consecutive days (Device)
4-CIPN
10 tDCS naïve patients with CIPN-Chemotherapy Induced Pain Neuropathy patients
干预措施: TDCS/sham procedure on five consecutive days (Device)
结局指标
主要结局
Changes in the amplitude of P300
时间窗: 15 min after and 120 min after the 1st tDCS, 15 min after and 120 min after the 5st tDCS, and at the follow up 1 week after the 5th tDCS.
Changes in the Latency of P300
时间窗: 15 min after and 120 min after the 1st tDCS, 15 min after and 120 min after the 5st tDCS, and at the follow up 1 week after the 5th tDCS.
次要结局
- Changes in Pain Thresholds for Tactile and Thermal Stimuli will be calculated as the difference between ratings obtained form pain threshold measurements before- and after tDCS(15 min after and 120 min after each tDCS stimulation)
- Changes in Pain Intensity-will be calculated as the difference in scores on the 11-point numerical pain rating scale (0-10)(15 min after and 120 min after each tDCS stimulation)
研究者
Pesach Shvartzman
Head Department of Family Medicine
Soroka University Medical Center