Peripheral Nerve and Spinal Cord Stimulation in Patients With Pain Syndrome as a Result of Lower Limb Amputation in Order to Relieve Pain Syndrome and Develop Phantom Pain Biomarkers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change according to the scale of the DN4 Neuropathic Pain Questionnaire
研究概览
简要总结
Brief Summary: The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord (SCS) stimulation with implantable electrodes. The researchers expect that PLP in patients with lower limb amputation will be relieved by peripheral nerve and the spinal cord stimulation. The possibility of finding EEG biomarkers for phantom pain will be explored.
详细描述
The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord stimulation (SCS) with implantable electrodes.
The study is conducted to collect information on the role of non-adaptive neuroplasticity and inhibitory descending antinociceptive influences, which determine the effect of peripheral nerve and spinal cord stimulation with implanted electrodes in patients with phantom limb pain as a result of amputation of the lower limb. Neuromodulation is a potential treatment option for chronic pain that may alter maladaptive neuroplasticity and enhance descending inhibitory pathways.
Study participants will be selected according to the inclusion criteria. Next, multichannel electrodes will be implanted in the region of the target peripheral nerves of the amputated limb and the corresponding segments of the spinal cord. The evaluation of the therapeutic effects of pain syndromes will be carried out in the mode of long-term repetitive nerve stimulation. Postoperative follow-up will be carried out from 2 weeks to 1 month. During the follow-up period, patients will complete scales and questionnaires daily.
The stimulator is turned on the day after surgery to assess pain relief. The patient is explained the rules for using the stimulator. The selection of stimulation parameters is carried out according to the generally accepted methodology (the stimulation zone should overlap the pain zone; stimulation should be in the nature of pleasant vibrations). The patient will be given a test stimulation diary to complete every day (at the end of the day) during the entire stimulation period.
The researchers expect that phantom limb pain in patients undergoing lower limb amputation will be relieved by peripheral nerve stimulation. We will explore the possibility of creating a personal phantom sensitivity map to optimize the stimulation program. We will study improving the quality of life and reducing pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •for the study:
- •Patients with implanted neuromodulation devices.
- •Amputation of the lower limb.
- •Age ranges from 18 to 65 years old.
- •The duration from the moment of amputation is from 12 months.
- •The presence of persistent chronic pain syndrome is from 4 to 10 points according to the Visual Analogue Scale
- •Absence of pregnancy at the time of implantation, confirmed by a pregnancy test.
排除标准
- •The presence of severe somatic pathology that prevents surgical treatment and participation in the study.
- •The presence of mental illness (including history), severe depression, suicidal tendencies, history of suicide.
- •The presence of gross orthopedic deformity in the limb above the amputation level.
- •History of oncology.
- •History of epilepsy.
- •Complicated TBI or history of stroke.
- •The impossibility of conducting electrical stimulation due to another somatic pathology.
- •Purulent septic pathology.
- •Drug addiction (including history).
- •Congenital malformation of the lower limb.
- •Anomalies in the development of the CNS.
- •Any conditions that fall under the exclusion criteria according to the researchers.
结局指标
主要结局
Change according to the scale of the DN4 Neuropathic Pain Questionnaire
时间窗: : baseline and up to 1 month
The DN4 Neuropathic Pain Questionnaire defines the neuropathic nature of pain with a point of 4 to 10.
Determining the effectiveness of phantom pain suppression based on the Test Stimulation Diary
时间窗: up to 1 month
The patient completes a Test Stimulation Diary at the end of each day, noting the location of phantom pain and the percentage of pain reduction during stimulation.
Change according to the scale of the PainDetect questionnaire
时间窗: up to 1 month
The PainDetect questionnaire reflects all possible parameters of pain and allows us to very clearly track the picture of the pain syndrome in dynamics. The score is made in the range from 0 (best score) to 38 (worst score) points.
Change in relative power in slow frequencies (alpha and theta ranges) on the EEG with the neurostimulator on/off and eyes open/closed.
时间窗: up to 1 month
Data analysis is done in MNE Python. An average reference is used. Artifact correction is carried out using the analysis of independent components. Additionally, band-pass filtering is applied in the range from 1 to 40 Hz. The general analysis pipeline includes the calculation of the normalized power spectral density, after which the average power of the alpha rhythm is divided by the average power of the theta rhythm. This ratio is compared under different experimental conditions
次要结局
未报告次要终点
研究者
Artur Biktimirov
Far Eastern Federal University
Far Eastern Federal University