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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active repetitive transcranial magnetic stimulation | Experimental | 10 hertz (Hz) rTMS will be administered over the primary motor area. Therapy will include 5 daily sessions (on consecutive week days). In every sessions 1500 magnetic pulses of 90% of the resting motor threshold intensity will be elicited. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active repetitive transcranial magnetic stimulation | Device | High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity. |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Severity Scale after 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. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Numeric Pain Severity Scale First Follow Up | 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. | Before rTMS, two weeks after finishing rTMS |
| Numeric Pain Severity Scale Second Follow Up | 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. | Before rTMS, four weeks after finishing rTMS |
| Visual Analog Scale of Pain Severity | An analog scale of the length of 100 milimeter. Total score of 100, with higher scores representing more severe pain. Change through the study. | Through study completion, an average of 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale after rTMS | Total score 64, with higher scores representing more severe depression. Change from baseline score in the Hospital Anxiety and Depression Scale to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Hospital Anxiety and Depression Scale First Follow Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justyna Brączyk, MS | Jagiellonian University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Medical College, Department of Neurology | Krakow | 31503 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19833552 | Background | Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. |
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After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements made at baseline, after rTMS, at the first and at the second follow up will be made available to other researchers on request.
The data will become available after the study results will be published.
On request send by e-mail: jakub.antczak@uj.edu.pl
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| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Patients will be randomly assigned to active and then sham stimulation or to sham and then active stimulation.
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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.
| Sham repetitive transcranial magnetic stimulation | Device | Sham stimulation to mimic the high frequency rTMS over the primary motor area. |
|
Total score 64, with higher scores representing more severe depression. Change from baseline score in the Hospital Anxiety and Depression Scale to the measurement taken two weeks after finishing rTMS. |
| Before rTMS, two weeks after finishing rTMS |
| Hospital Anxiety and Depression Scale Second Follow Up | Total score 64, with higher scores representing more severe depression. Change from baseline score in the Hospital Anxiety and Depression Scale to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| 36-Item Short Form Health Survey after rTMS | Total score, range 0 to 800, with lower values representing a worse outcome. Change from baseline score in the 36-Item Short Form Health Survey to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| 36-Item Short Form Health Survey First Follow Up | Total score, range 0 to 800, with lower values representing a worse outcome. Change from baseline score in the 36-Item Short Form Health Survey to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| 36-Item Short Form Health Survey Second Follow Up | Total score, range 0 to 800, with lower values representing a worse outcome. Change from baseline score in the 36-Item Short Form Health Survey to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function after rTMS | Total score, range 0 to 100, with lower values representing a worse outcome. Change from baseline score in Neuro-Qol Upper Extremity Function to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function First Follow Up | Total score, range 0 to 100, with lower values representing a worse outcome. Change from baseline score in Neuro-Qol Upper Extremity Function to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Second Follow Up | Total score, range 0 to 100, with lower values representing a worse outcome. Change from baseline score in Neuro-Qol Upper Extremity Function to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of pain threshold to electric stimuli after rTMS | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports that the sensation has become painful. Change from baseline pain threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of sensory threshold to electric stimuli after rTMS | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports the first nonpainful tactile sensation. Change from baseline sensory threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of pain threshold to electric stimuli First Follow Up | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports that the sensation has become painful. Change from baseline pain threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of sensory threshold to electric stimuli First Follow Up | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports the first nonpainful tactile sensation. Change from baseline sensory threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of pain threshold to electric stimuli Second Follow Up | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports that the sensation has become painful. Change from baseline pain threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of sensory threshold to electric stimuli Second Follow Up | Electrocutaneus stimulation with gradually increasing intensity from 0mA until a patient reports the first nonpainful tactile sensation. Change from baseline sensory threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of cold sensation threshold to cold stimuli after rTMS | Stimulation with cold temperature stimuli, gradually colder, starting from from 32 degree Celcius until patient will report that he feels cold. Change from baseline cold sensation threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of pain threshold to cold temeprature stimuli after rTMS | Stimulation with cold temperature stimuli, gradually colder, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of cold sensation threshold to cold temeprature stimuli First Follow Up | Stimulation with cold temperature stimuli, gradually colder, starting from from 32 degree Celcius until patient will report that he feels cold. Change from baseline cold sensation threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of pain threshold to cold temeprature stimuli First Follow Up | Stimulation with cold temperature stimuli, gradually colder, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of cold sensation threshold to cold temeprature stimuli Second Follow Up | Stimulation with cold temperature stimuli, gradually colder, starting from from 32 degree Celcius until patient will report that he feels cold. Change from baseline cold sensation threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of pain threshold to cold temeprature stimuli Second Follow Up | Stimulation with cold temperature stimuli, gradually colder, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of warmth sensation threshold to warm temeprature stimuli after rTMS | Stimulation with warm temperature stimuli, gradually warmer, starting from from 32 degree Celcius until patient will report that he feels warmth. Change from baseline warmth sensation threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of pain threshold to warm temeprature stimuli after rTMS | Stimulation with warm temperature stimuli, gradually warmer, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Assessment of warmth sensation threshold to warm temeprature stimuli First Follow Up | Stimulation with warm temperature stimuli, gradually warmer, starting from from 32 degree Celcius until patient will report that he feels warmth. Change from baseline warmth sensation threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of pain threshold to warm temeprature stimuli First Follow Up | Stimulation with warm temperature stimuli, gradually warmer, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Assessment of warmth sensation threshold to warm temeprature stimuli Second Follow Up | Stimulation with warm temperature stimuli, gradually warmer, starting from from 32 degree Celcius until patient will report that he feels warmth. Change from baseline warmth sensation threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Assessment of pain threshold to warm temeprature stimuli Second Follow Up | Stimulation with warm temperature stimuli, gradually warmer, starting from 32 degree Celcius until patient starts to perceive stimuli as painful. Change from baseline pain threshold to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Bilateral Dynamometric Assessment of the strength of the index finger flexion after rTMS | Change from baseline strength of the index finger flexion to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS | Change from baseline strength of the foot extension to the measurement taken after finishing rTMS. | Before rTMS, immediately after (on same day) finishing rTMS. |
| Bilateral Dynamometric Assessment of the strength of the index finger flexion First Follow Up | Change from baseline strength of the index finger flexion to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Bilateral Dynamometric Assessment of the strength of the foot extension flexion First Follow Up | Change from baseline strength of the foot extension to the measurement taken two weeks after finishing rTMS. | Before rTMS, two weeks after finishing rTMS |
| Bilateral Dynamometric Assessment of the strength of the index finger flexion Second Follow Up | Change from baseline strength of the index finger flexion to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow Up | Change from baseline strength of the index foot extension to the measurement taken four weeks after finishing rTMS. | Before rTMS, four weeks after finishing rTMS |
| D013568 |
| Pathological Conditions, Signs and Symptoms |