Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Numeric Pain Severity Scale First Follow Up
研究概览
简要总结
Vasculitic neuropathy (VN) results from inflammation and destruction of the walls of predominantly small vessels with subsequent ischemic damage of peripheral nerves. VN is painful in vast majority of patients and the pain is intractable with pharmacotherapy in about 40% of cases. 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. The purpose of this study is to compare the effectiveness of analgesic effect of rTMS in vasculitic neuropathy with sham stimulation.
详细描述
Vasculitic neuropathies (VN) are a group of disorders resulting from inflammation of predominantly small vessels with destruction of their walls and subsequent ischemic damage of peripheral nerves. Neural damage may or may not coexist with the damage of other organs. Examples of conditions associated with VN include diabetes, microscopic polyangiitis, eosinophilic granulomatosis with polyangiitis (Churg-Strauss), granulomatosis with polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus and others. VN is painful in about 80% of patients of whom 40% suffer from the pain intractable with pharmacological therapy. 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 widely regarded as one of alternative methods to alleviate pain associated with various kind of neuropathies. The purpose of this study is to compare the effectiveness of analgesic effect of rTMS in vasculitic neuropathy with sham stimulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
- 否
入选标准
- •Diagnosis of vasculitic 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 milimeter or more on the 100 milimeter 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
- •Contraindications for rTMS as listed by the Guidelines of the International Federation of Clinical Neurophysiology (Rossi et al. 2009) i.e. seizure in the past, epilepsy, presence of magnetic material in the reach of magnetic field, pregnancy, likelihood to get pregnant, intracranial electrodes, cardiac pacemaker or intracardiac lines, frequent syncopes
结局指标
主要结局
Numeric Pain Severity Scale First Follow Up
时间窗: Before rTMS, two weeks after finishing rTMS
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken two weeks after finishing rTMS.
Numeric Pain Severity Scale Second Follow Up
时间窗: Before rTMS, four weeks after finishing rTMS
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken four weeks after finishing rTMS.
Visual Analog Scale of Pain Severity
时间窗: Through study completion, an average of 10 weeks
An analog scale of the length of 100 milimeter. Total score of 100, with higher scores representing more severe pain. Change through the study.
Numeric Pain Severity Scale after rTMS
时间窗: Before rTMS, immediately after (on same day) finishing rTMS.
Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken after finishing rTMS.
次要结局
- Hospital Anxiety and Depression Scale after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Hospital Anxiety and Depression Scale First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of pain threshold to electric stimuli First Follow Up(Before rTMS, two weeks after finishing rTMS)
- 36-Item Short Form Health Survey First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of pain threshold to cold temeprature stimuli 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)
- Assessment of pain threshold to electric stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of pain threshold to electric stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Assessment of pain threshold to cold temeprature stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of pain threshold to cold temeprature stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Assessment of warmth sensation threshold to warm temeprature stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of pain threshold to warm temeprature stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of pain threshold to warm temeprature stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Hospital Anxiety and Depression Scale Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- 36-Item Short Form Health Survey after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- 36-Item Short Form Health Survey Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Assessment of sensory threshold to electric stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of sensory threshold to electric stimuli First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of cold sensation threshold to cold temeprature stimuli First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of sensory threshold to electric stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Assessment of cold sensation threshold to cold stimuli after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Assessment of cold sensation threshold to cold temeprature stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Assessment of warmth sensation threshold to warm temeprature stimuli First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of pain threshold to warm temeprature stimuli First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Assessment of warmth sensation threshold to warm temeprature stimuli Second Follow Up(Before rTMS, four weeks after finishing rTMS)
- Bilateral Dynamometric Assessment of the strength of the index finger flexion after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS(Before rTMS, immediately after (on same day) finishing rTMS.)
- Bilateral Dynamometric Assessment of the strength of the index finger flexion First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Bilateral Dynamometric Assessment of the strength of the foot extension flexion First Follow Up(Before rTMS, two weeks after finishing rTMS)
- Bilateral Dynamometric Assessment of the strength of the index finger flexion Second Follow Up(Before rTMS, four weeks after finishing rTMS)
研究者
Jakub Antczak
Principal Investigator
Jagiellonian University