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临床试验/NCT05295498
NCT05295498招募中不适用

Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy

Jakub Antczak2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年11月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
Jakub Antczak
入组人数
70
试验地点
2
主要终点
Visual Analogue Scale of Pain Severity after rTMS

研究概览

简要总结

Peripheral neuropathy is a frequent condition, commonly associated with pain. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity and is regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

详细描述

Peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity. In this method, series of magnetic stimuli are delivered to the cerebral cortex, where they turn to electric current and depolarize repetitively the targeted neurons. If the stimulation is repeated during subsequent days it is capable to modify the activity of targeted cortical area for weeks or even months and by this way to achieve therapeutic effect. rTMS is most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rTMS. In patients suffering from neuropathic pain rTMS is delivered with high frequency, over primary motor areas (PMA). Stimulation of PMA should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple (Participant, Investigator, Outcomes Assessor). Sham stimulation will be provided by holding the stimulating coil perpendicularly to the scalp, which assures similar impression as during active stimulation but prevents significant magnetic field to reach the brain tissue.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of peripheral neuropathy
  • Neuropathic pain of constant severity since not less than a month and requiring use of analgesics more than once a week
  • Score of 30 millimeter or more on the 100 millimeter visual analog scale of pain intensity at inclusion

排除标准

  • Severe depression
  • Personality disorders and other psychiatric conditions, which could disturb the participation in the study
  • Cognitive deficits, which could disturb the participation in the study
  • Presence of magnetic material in the reach of magnetic field
  • Pregnancy
  • Likelihood to get pregnant
  • Intracranial electrodes

研究组 & 干预措施

Active repetitive transcranial magnetic stimulation

Experimental

10 hertz (Hz) rTMS will be administered over the primary motor area. Therapy will include 6 sessions (three sessions in two consecutive days). In every sessions 1500 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.

干预措施: Active repetitive transcranial magnetic stimulation (Device)

Sham repetitive transcranial magnetic stimulation

Sham Comparator

Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.

干预措施: Sham repetitive transcranial magnetic stimulation (Device)

结局指标

主要结局

Visual Analogue Scale of Pain Severity after rTMS

时间窗: Through study completion, an average of 1 year.

An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after finishing rTMS.

Visual Analogue Scale of Pain Severity First Follow-up

时间窗: Before rTMS, up to one day after finishing rTMS.

An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after two weeks after finishing rTMS.

Visual Analogue Scale of Pain Severity Second Follow-up

时间窗: Before rTMS, four weeks after finishing rTMS.

An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after four weeks after finishing rTMS.

次要结局

  • Numeric Pain Severity Scale after rTMS(Before rTMS, up to one day after finishing rTMS.)
  • Numeric Pain Severity Scale First Follow-up(Before rTMS, two weeks after finishing rTMS.)
  • Numeric Pain Severity Scale Second Follow-up(Before rTMS, four weeks after finishing rTMS.)
  • Neuropathic Pain Symptoms Inventory after rTMS(Before rTMS, up to one day after finishing rTMS.)
  • Neuropathic Pain Symptoms Inventory First Follow-up(Before rTMS, two weeks after finishing rTMS.)
  • Neuropathic Pain Symptoms Inventory Second Follow-up(Before rTMS, four weeks after finishing rTMS.)
  • Athens Insomnia Scale after rTMS(Before rTMS, up to one day after finishing rTMS.)
  • Athens Insomnia Scale First Follow-up(Before rTMS, two weeks after finishing rTMS.)
  • Athens Insomnia Scale Second Follow-up(Before rTMS, four weeks after finishing rTMS.)
  • Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS(Before rTMS, up to one day after finishing rTMS.)
  • Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up(Before rTMS, two weeks after finishing rTMS.)
  • Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up(Before rTMS, four weeks after finishing rTMS.)

研究者

发起方
Jakub Antczak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jakub Antczak

Principal Investigator

Jagiellonian University

研究点 (2)

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