Peripheral NeuropathyNCT05295498
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
A study testing Active repetitive transcranial magnetic stimulation in people with Peripheral Neuropathy, run by Jakub Antczak at 1 site in Poland.
Trial summary
Peripheral neuropathy is a frequent condition, commonly associated with pain. 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral 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
- 70 participants
- Where
- 1 sitePoland
- Study dates
- 4 Nov 2022to 30 Sep 2026
- 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 peripheral 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 millimeter or more on the 100 millimeter 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
- Epilepsy
- Presence of magnetic material in the reach of magnetic field
- Pregnancy
- Likelihood to get pregnant
- Intracranial electrodes
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University Medical College
Krakow, 31008
Jakub Antczak, MD, jakub.antczak@uj.edu.pl
About this study
Official title: Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
Peripheral neuropathy is a frequent condition, commonly associated with pain. 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. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
Read the detailed description
Peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. 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 most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rTMS. In patients suffering from neuropathic pain rTMS is delivered with high frequency, over primary motor areas (PMA). Stimulation of PMA should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
- Conditions
- Peripheral Neuropathy
- Being tested
- Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- Peripheral neuropathy, Neuropathic pain, rTMS, analgesic effect
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia
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 6 sessions (three sessions in two consecutive 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.
Visual Analogue Scale of Pain Severity after rTMS
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after finishing rTMS.
Measured: Through study completion, an average of 1 year.
Visual Analogue Scale of Pain Severity First Follow-up
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after two weeks after finishing rTMS.
Measured: Before rTMS, up to one day after finishing rTMS.
Visual Analogue Scale of Pain Severity Second Follow-up
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after four weeks after finishing rTMS.
Measured: Before rTMS, four weeks after finishing rTMS.
Secondary outcomes (12)
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, up to one day after 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 after four weeks after finishing rTMS.
Measured: Before rTMS, four weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory after rTMS
Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken after finishing rTMS.
Measured: Before rTMS, up to one day after finishing rTMS.
Neuropathic Pain Symptoms Inventory First Follow-up
Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken two weeks after finishing rTMS.
Measured: Before rTMS, two weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory Second Follow-up
Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken four weeks after finishing rTMS.
Measured: Before rTMS, four weeks after finishing rTMS.
Athens Insomnia Scale after rTMS
Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken after finishing rTMS.
Measured: Before rTMS, up to one day after finishing rTMS.
Athens Insomnia Scale First Follow-up
Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken two weeks after finishing rTMS.
Measured: Before rTMS, two weeks after finishing rTMS.
Athens Insomnia Scale Second Follow-up
Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale 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 after rTMS
Change from baseline strength of the foot extension to the measurement taken after finishing rTMS.
Measured: Before rTMS, up to one day after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension 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 foot extension Second Follow-up
Change from baseline strength of the 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 posted25 Mar 2022
- Study start4 Nov 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral 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
- Parallel groups
- Model description
- Parallel Assignment. Patients will be randomly assigned to active or to sham stimulation.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Antczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Tomasz Klupa, Professor, Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295498
- Sponsor's protocol ID
- JagiellonianU69
- Status last verified
- Oct 2024
- First submitted
- 7 Mar 2022
- Last updated
- 10 Oct 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05295498
- Acronym / sponsor ID
- JagiellonianU69
- Conditions
- Peripheral Neuropathy
- Keywords
- Peripheral neuropathy, Neuropathic pain, rTMS, analgesic effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jakub AntczakUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 25 Mar 2022 (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.
Peripheral neuropathy is a frequent condition, commonly associated with pain. 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. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
Detailed description
Peripheral neuropathy is a frequent condition, commonly associated with pain, which is often drug resistant. 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 most commonly used to treat drug-resistant depression but a number of other psychiatric and neurologic conditions is increasingly being regarded as therapeutic indication for rTMS. In patients suffering from neuropathic pain rTMS is delivered with high frequency, over primary motor areas (PMA). Stimulation of PMA should result in modulation of thalamic activity, achieved by antidromic excitation of thalamocortical connections. rTMS is usually performed once a day and the whole therapy of neuropathic pain lasts one week. In a number of recent clinical trials including patients with depression and some other disorders, rTMS was delivered several times a day, which reduced the time of the whole therapy. This approach was termed an accelerated rTMS. The purpose of this study is to investigate feasibility of accelerated rTMS in treatment of neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment. Patients will be randomly assigned to active or to sham 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 6 sessions (three sessions in two consecutive 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 peripheral 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 millimeter or more on the 100 millimeter visual analog scale of pain intensity at inclusion
Key exclusion criteria (8 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
- Epilepsy
- Presence of magnetic material in the reach of magnetic field
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
Visual Analogue Scale of Pain Severity after rTMS
Time frame: Through study completion, an average of 1 year.
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after finishing rTMS.
Visual Analogue Scale of Pain Severity First Follow-up
Time frame: Before rTMS, up to one day after finishing rTMS.
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after two weeks after finishing rTMS.
Visual Analogue Scale of Pain Severity Second Follow-up
Time frame: Before rTMS, four weeks after finishing rTMS.
An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after four weeks after finishing rTMS.
12 secondary outcomes
Numeric Pain Severity Scale after rTMS
Time frame: Before rTMS, up to one day after finishing rTMS.
Numeric Pain Severity Scale First Follow-up
Time frame: Before rTMS, two weeks after finishing rTMS.
Numeric Pain Severity Scale Second Follow-up
Time frame: Before rTMS, four weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory after rTMS
Time frame: Before rTMS, up to one day after finishing rTMS.
Neuropathic Pain Symptoms Inventory First Follow-up
Time frame: Before rTMS, two weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory Second Follow-up
Time frame: Before rTMS, four weeks after finishing rTMS.
Athens Insomnia Scale after rTMS
Time frame: Before rTMS, up to one day after finishing rTMS.
Athens Insomnia Scale First Follow-up
Time frame: Before rTMS, two weeks after finishing rTMS.
Athens Insomnia Scale Second Follow-up
Time frame: Before rTMS, four weeks after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS
Time frame: Before rTMS, up to one day after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up
Time frame: Before rTMS, two 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- 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.
Tomasz Klupa, Professor 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 Peripheral Neuropathy, run by Jakub Antczak 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 8 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakub M Antczak, MD (+48 795 421 153, jakub.antczak@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale of Pain Severity after rTMS (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024.