Clinical trial NCT04720196: Analgesic Effect of rTMS in Vasculitic Neuropathy
Official title: Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vasculitic Neuropathy
Keywords: vasculitis
neuropathy
pain
transcranial magnetic stimulation
analgesic effect
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomly assigned to active and then sham stimulation or to sham and then active stimulation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Numeric Pain Severity Scale after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Numeric Pain Severity Scale First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Numeric Pain Severity Scale Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Visual Analog Scale of Pain Severity
timeFrame: Through study completion, an average of 10 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Hospital Anxiety and Depression Scale First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Hospital Anxiety and Depression Scale Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: 36-Item Short Form Health Survey after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: 36-Item Short Form Health Survey First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: 36-Item Short Form Health Survey Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of pain threshold to electric stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of sensory threshold to electric stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of pain threshold to electric stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of sensory threshold to electric stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of pain threshold to electric stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of sensory threshold to electric stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of cold sensation threshold to cold stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of pain threshold to cold temeprature stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of cold sensation threshold to cold temeprature stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of pain threshold to cold temeprature stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of cold sensation threshold to cold temeprature stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of pain threshold to cold temeprature stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of warmth sensation threshold to warm temeprature stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of pain threshold to warm temeprature stimuli after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Assessment of warmth sensation threshold to warm temeprature stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of pain threshold to warm temeprature stimuli First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Assessment of warmth sensation threshold to warm temeprature stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Assessment of pain threshold to warm temeprature stimuli Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Bilateral Dynamometric Assessment of the strength of the index finger flexion after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS
timeFrame: Before rTMS, immediately after (on same day) finishing rTMS.
measure: Bilateral Dynamometric Assessment of the strength of the index finger flexion First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Bilateral Dynamometric Assessment of the strength of the foot extension flexion First Follow Up
timeFrame: Before rTMS, two weeks after finishing rTMS
measure: Bilateral Dynamometric Assessment of the strength of the index finger flexion Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
measure: Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow Up
timeFrame: Before rTMS, four weeks after finishing rTMS
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College, Department of Neurology
Study officials:
affiliation: Jagiellonian University
name: Justyna Brączyk, MS
role: STUDY_CHAIR
References:
citation: 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.