Analgesic Effect of rTMS in Vasculitic Neuropathy

Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy

Sponsors

Lead Sponsor: Jagiellonian University

Source Jagiellonian University
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.

Overall Status Recruiting
Start Date 2021-01-25
Completion Date 2023-06-01
Primary Completion Date 2022-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Numeric Pain Severity Scale after rTMS Before rTMS, immediately after (on same day) 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
Visual Analog Scale of Pain Severity Through study completion, an average of 10 weeks
Secondary Outcome
Measure Time Frame
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
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 First Follow Up Before rTMS, two weeks after 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 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
Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function 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 sensory threshold to electric stimuli after rTMS Before rTMS, immediately after (on same day) finishing rTMS.
Assessment of pain threshold to electric stimuli First Follow Up Before rTMS, two weeks after finishing rTMS
Assessment of sensory threshold to electric stimuli First Follow Up Before rTMS, two weeks after finishing rTMS
Assessment of pain threshold to electric stimuli Second Follow Up Before rTMS, four 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 pain threshold to cold temeprature stimuli after rTMS Before rTMS, immediately after (on same day) finishing rTMS.
Assessment of cold sensation threshold to cold temeprature stimuli 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
Assessment of cold sensation threshold to cold temeprature stimuli Second Follow Up Before rTMS, four weeks after 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 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
Assessment of pain 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
Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow Up Before rTMS, four weeks after finishing rTMS
Enrollment 24
Condition
Intervention

Intervention Type: Device

Intervention Name: Active repetitive transcranial magnetic stimulation

Description: High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.

Arm Group Label: Active repetitive transcranial magnetic stimulation

Intervention Type: Device

Intervention Name: Sham repetitive transcranial magnetic stimulation

Description: Sham stimulation to mimic the high frequency rTMS over the primary motor area.

Arm Group Label: Sham repetitive transcranial magnetic 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Justyna Brączyk, MS Study Chair Jagiellonian University
Overall Contact

Last Name: Jakub M Antczak, MD

Phone: +48 795 421 153

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Jagiellonian University Medical College, Department of Neurology Jakub M Antczak, MD +48 795 421 153 [email protected] Justyna Brączyk, MS Sub-Investigator
Location Countries

Poland

Verification Date

2022-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Jagiellonian University

Investigator Full Name: Jakub Antczak

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active repetitive transcranial magnetic stimulation

Type: Experimental

Description: 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.

Label: Sham repetitive transcranial magnetic stimulation

Type: Sham Comparator

Description: 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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Patients will be randomly assigned to active and then sham stimulation or to sham and then active stimulation.

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: 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.

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