Vasculitic NeuropathyNCT04720196
Analgesic Effect of rTMS in Vasculitic Neuropathy
A study testing Active repetitive transcranial magnetic stimulation in people with Vasculitic Neuropathy, run by Jagiellonian University at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitic Neuropathy
- What is being tested?
- Active repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 sitePoland
- Study dates
- 25 Jan 2021to 21 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Neurology
Krakow, 31503
About this study
Official title: 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.
Read the 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.
- Conditions
- Vasculitic Neuropathy
- Being tested
- Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- vasculitis, neuropathy, pain, transcranial magnetic stimulation, analgesic effect
- Medical subject headings
- Vasculitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive transcranial magnetic stimulationDevice
High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.
Sham repetitive transcranial magnetic stimulationDevice
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active repetitive transcranial magnetic stimulation |
| 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. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 10 weeks
Secondary outcomes (33)
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.
Measured: Before rTMS, immediately after (on same day) finishing rTMS.
Hospital Anxiety and Depression Scale First 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 two weeks after finishing rTMS.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before rTMS, four weeks after finishing rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start25 Jan 2021
- Primary completion20 Sep 2023
- Study completion21 Sep 2023
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasculitic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients will be randomly assigned to active and then sham stimulation or to sham and then active stimulation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Justyna Brączyk, MS, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720196
- Sponsor's protocol ID
- JagiellonianU63
- Status last verified
- Sep 2023
- First submitted
- 16 Jan 2021
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 19833552
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Repetitive Transcranial Magnetic Stimulation in Painful Vasculitic Neuropathy
- ClinicalTrials.gov ID
- NCT04720196
- Acronym / sponsor ID
- JagiellonianU63
- Conditions
- Vasculitic Neuropathy
- Keywords
- vasculitis, neuropathy, pain, transcranial magnetic stimulation, analgesic effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to active and then sham stimulation or to sham and then active stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active repetitive transcranial magnetic stimulation | Experimental | Device: Active repetitive transcranial magnetic stimulation10 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. |
| Sham repetitive transcranial magnetic stimulation | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active repetitive transcranial magnetic stimulationHigh frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity. | Device | Active repetitive transcranial magnetic stimulation |
| Sham repetitive transcranial magnetic stimulationSham stimulation to mimic the high frequency rTMS over the primary motor area. | Device | Sham repetitive transcranial magnetic stimulation |
Primary outcome
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.
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.
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.
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.
33 secondary outcomes
Hospital Anxiety and Depression Scale after rTMS
Time frame: 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
Hospital Anxiety and Depression Scale Second Follow Up
Time frame: 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.
36-Item Short Form Health Survey First Follow Up
Time frame: 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
Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function after rTMS
Time frame: 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
Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Second Follow Up
Time frame: 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.
Assessment of sensory threshold to electric stimuli after rTMS
Time frame: 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
Assessment of sensory threshold to electric stimuli First Follow Up
Time frame: 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
Assessment of sensory threshold to electric stimuli Second Follow Up
Time frame: 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.
Assessment of pain threshold to cold temeprature stimuli after rTMS
Time frame: 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
Assessment of pain threshold to cold temeprature stimuli First Follow Up
Time frame: 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
Assessment of pain threshold to cold temeprature stimuli Second Follow Up
Time frame: 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.
Assessment of pain threshold to warm temeprature stimuli after rTMS
Time frame: 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
Assessment of pain threshold to warm temeprature stimuli First Follow Up
Time frame: 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
Assessment of pain threshold to warm temeprature stimuli Second Follow Up
Time frame: 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.
Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS
Time frame: 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
Bilateral Dynamometric Assessment of the strength of the foot extension flexion First Follow Up
Time frame: 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
Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow Up
Time frame: Before rTMS, four weeks after finishing rTMS
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Background: PubMed 19833552Rossi 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justyna Brączyk, MS study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive transcranial magnetic stimulation in people with Vasculitic Neuropathy, run by Jagiellonian University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Severity Scale after rTMS (time frame: Before rTMS, immediately after (on same day) finishing rTMS.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.