Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
研究概览
简要总结
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.
详细描述
Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.
The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.
Participants with Neuropathic Pain:
After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.
The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Healthy Adults:
- •Between age of 21 and 60
- •No prescription medications in previous 3 months
- •No seizure history
- •No depression
- •Not suicidal
- •No anxiety
- •No hospitalizations or surgeries in previous 6 months
- •No history of chronic pain conditions
- •No implanted metal devices (e.g., pacemakers, metal plates, wires)
- •Not pregnant
- •No alcohol abuse/dependence history in previous 6 months
- •No illicit drug use in previous 6 months
- •Capable of reading, writing, giving consent, following instructions
- •No history of brain surgery or history of loss of consciousness >15 minutes
- •No history of autoimmune or endocrine disorder
- •No significant anxiety about entering MRI scanner
- •For Patients with neuropathic pain:
- •Between age of 21 and 75
- •No seizure history
- •Not taking medications shown to increase seizure risk (6 months)
- •Not suicidal
- •No hospitalizations or surgeries in previous 3 months
- •No implanted metal devices (e.g., pacemakers, metal plates, wires)
- •Not pregnant
- •No alcohol abuse/dependence history in previous 6 months
- •No illicit drug use in previous 6 months
- •Capable of reading, writing, giving consent, following instructions
- •Chronic pain (>6 months), not significantly relieved by pharmacological treatment
- •No significant anxiety about entering MRI scanner
排除标准
- 未提供
结局指标
主要结局
Clinical neuropathic pain ratings, activity levels, analgesic medication usage, mood ratings, laboratory pain measures (thermal and mechanical pain thresholds, suprathreshold pain ratings, and wind-up pain ratings).
时间窗: measured during the study period
次要结局
未报告次要终点