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NCT Number: NCT05295498

Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

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.

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Key information

Conditions

Peripheral Neuropathy Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jagiellonian University Medical College

Krakow, 31008, Poland

Location status: Recruiting

Location contact

Jakub Antczak, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • Epilepsy
  • Presence of magnetic material in the reach of magnetic field
  • Pregnancy
  • Likelihood to get pregnant
  • Intracranial electrodes

Treatment and study plan

Active Repetitive Transcranial Magnetic Stimulation

Device

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 stimulation

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Numeric Pain Severity Scale after rTMS

    Time frame: Before rTMS, up to one day 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 after finishing rTMS.

  2. 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.

  3. 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 after four weeks after finishing rTMS.

  4. Neuropathic Pain Symptoms Inventory after rTMS

    Time frame: Before rTMS, up to one day after finishing 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.

  5. Neuropathic Pain Symptoms Inventory First Follow-up

    Time frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.

  6. Neuropathic Pain Symptoms Inventory Second Follow-up

    Time frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.

  7. Athens Insomnia Scale after rTMS

    Time frame: Before rTMS, up to one day after finishing 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.

  8. Athens Insomnia Scale First Follow-up

    Time frame: Before rTMS, two weeks after finishing rTMS.

    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.

  9. Athens Insomnia Scale Second Follow-up

    Time frame: Before rTMS, four weeks after finishing rTMS.

    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.

  10. Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS

    Time frame: Before rTMS, up to one day after finishing rTMS.

    Change from baseline strength of the foot extension to the measurement taken after finishing rTMS.

  11. Bilateral Dynamometric Assessment of the strength of the foot extension 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.

  12. 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 foot extension to the measurement taken four weeks after finishing rTMS.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela G Rusin, MD

CONTACT

[email protected]

+48 601 661 607

Jakub M Antczak, MD

CONTACT

[email protected]

+48 795 421 153

Sponsors and collaborators

Lead sponsor

Jakub Antczak

Other

Registry information

Official study title

Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2022
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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