Analgesic Effect of rTMS in Vasculitic Neuropathy

September 28, 2023 updated by: Jakub Antczak, Jagiellonian University

Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Poland
      • Kraków, Poland, 31503
        • Jagiellonian University Medical College, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham repetitive transcranial magnetic stimulation
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.
Device: Sham repetitive transcranial magnetic stimulation
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
Experimental: Active repetitive transcranial magnetic stimulation
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.
Device: Active repetitive transcranial magnetic stimulation
High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Severity Scale after rTMS
Time Frame: 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.
Before rTMS, immediately after (on same day) finishing rTMS.
Numeric Pain Severity Scale First Follow Up
Time Frame: 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.
Before rTMS, two weeks after finishing rTMS
Numeric Pain Severity Scale Second Follow Up
Time Frame: 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.
Before rTMS, four weeks after finishing rTMS
Visual Analog Scale of Pain Severity
Time Frame: 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.
Through study completion, an average of 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale after rTMS
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Hospital Anxiety and Depression Scale Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
36-Item Short Form Health Survey after rTMS
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
36-Item Short Form Health Survey Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 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
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of pain threshold to electric stimuli after rTMS
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of sensory threshold to electric stimuli First Follow Up
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of pain threshold to electric stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of sensory threshold to electric stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of cold sensation threshold to cold stimuli after rTMS
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of pain threshold to cold temeprature stimuli First Follow Up
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of cold sensation threshold to cold temeprature stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of pain threshold to cold temeprature stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of warmth sensation threshold to warm temeprature stimuli after rTMS
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of pain threshold to warm temeprature stimuli First Follow Up
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
Before rTMS, two weeks after finishing rTMS
Assessment of warmth sensation threshold to warm temeprature stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
Before rTMS, four weeks after finishing rTMS
Assessment of pain threshold to warm temeprature stimuli Second Follow Up
Time Frame: Before rTMS, four weeks after finishing 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 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, immediately after (on same day) finishing 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
Time Frame: Before rTMS, two weeks after finishing rTMS
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
Time Frame: Before rTMS, two weeks after finishing rTMS
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
Time Frame: Before rTMS, four weeks after finishing rTMS
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
Time Frame: Before rTMS, four weeks after finishing rTMS
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jagiellonian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Justyna Brączyk, MS, Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JagiellonianU63

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will become available after the study results will be published.

IPD Sharing Access Criteria

On request send by e-mail: jakub.antczak@uj.edu.pl

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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