Transcranial Direct Current Stimulation to Lower Neuropathic Pain in People With Multiple Sclerosis: a Mechanistic FDG-PET Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Cerebral Glucose Uptake in Patients With Multiple Sclerosis With Neuropathic Pain
研究概览
简要总结
Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral prefrontal and motor cortex has been reported to be able to decrease pain sensation and to increase pain threshold in healthy subjects and is effective in reducing central chronic pain in patients with multiple sclerosis (PwMS.) In spite of the encouraging results of tDCS in PwMS, detailed mechanisms accounting for its analgesic effect have not yet been elucidated.
This will be the first study to determine the effects of tDCS on whole and regional brain activity in PwMS with neuropathic pain to identify potential mechanisms of the analgesic effects of tDCS. These findings will provide targets for future studies investigating different stimulation areas, possible short- and long-term side effects, and specific target areas for other precise stimulation techniques such as transcranial magnetic stimulation.
详细描述
The investigators aim is to identify changes in brain activation following transcranial direct current stimulation (tDCS), and determine whether these changes are associated with reduced ratings of pain. The investigators hypothesize that the analgesic effects of tDCS are associated with altered glucose metabolism of key regions of the top-down pain modulatory system, such as the dorsolateral prefrontal cortex (DLPFC) and medulla.
This study will follow an interventional protocol with two groups. Upon enrollment into the study, all participants will undergo testing for the outcome measures described above. Each participant will then be randomly assigned into the SHAM or tDCS group for the study intervention. This study will be completed over the course of 6 consecutive days and 1 follow-up phone call 1 week after the final testing for each participant (total of 13 days).
Two age and sex matched groups, each n =8, will receive either tDCS or SHAM stimulation.
All of the following measures will be performed before and after the tDCS or SHAM intervention.
Fluorodeoxyglucose ([18F] FDG) - Whole and regional brain FDG uptake will be measured to determine the mechanistic effect of tDCS on brain activity.
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
- Double (Participant, Care Provider)
盲法说明
Patients and assessing investigator will be blinded to group allocation while the treating investigator, who has to set the tDCS or sham-stimulation protocol on the stimulator, will be the only person aware of the stimulation condition. To minimize communication between blinded and non-blinded participants, the treating investigator will be instructed not to talk to patients and the assessing investigator about the study protocol.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple Sclerosis (PwMS)
- •Age range 18-65
- •Expanded disability status scale comprised between 1.5 and 6.5 with relapsing remitting MS (RRMS) in remitting phase
- •Presenting with chronic, drug-resistant, neuropathic pain
- •Patients must score at or above a 0 on the Neuropathic Pain Questionnaire (NPQ).
- •Patients must score at least a 40 mm on the visual analog scale (VAS) for pain perception at baseline
- •All analgesic medications discontinued at least 24 hours before entering the study
排除标准
- •Any change in:
- •disease-modifying medications, or
- •a relapse of disease symptoms within the last 60 days
- •History of seizures
- •History of traumatic brain injury
- •History of claustrophobia
- •Presence of:
- •pacemakers,
- •aneurysm clips,
- •artificial heart valves,
- •metallic prostheses, or
- •pregnancy.
- •Recent hospitalization (within the last 3 months)
- •Enforced bed rest/sedentary state
- •Resting plasma glucose greater than 200 mg/dl
- •Presence of other neurological disorders.
结局指标
主要结局
Cerebral Glucose Uptake in Patients With Multiple Sclerosis With Neuropathic Pain
时间窗: 1 week
Whole and regional brain glucose uptake via positron emission tomography with a glucose analogue tracer will be measured to determine the mechanistic effect of transcranial direct current stimulation on brain activity in subjects. Glucose uptake will be determined in patients with multiple sclerosis who received brain stimulation and patients with multiple sclerosis who received SHAM. The outcome variable is the mean Standardized Uptake Value.
次要结局
- Change in Neuropathic Symptom Inventory(1 week)
- Change in Neuropathic Pain as Recorded on a Visual Analog Scale (VAS).(1 week)
研究者
Thorsten Rudroff
Associate Professor
University of Iowa