Clinical trial NCT05295498: Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
Official title: Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Neuropathy
Keywords: Peripheral neuropathy
Neuropathic pain
rTMS
analgesic effect
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment. Patients will be randomly assigned to active or to sham stimulation.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale of Pain Severity after rTMS
timeFrame: Through study completion, an average of 1 year.
measure: Visual Analogue Scale of Pain Severity First Follow-up
timeFrame: Before rTMS, up to one day after finishing rTMS.
measure: Visual Analogue Scale of Pain Severity Second Follow-up
timeFrame: Before rTMS, four weeks after finishing rTMS.
Secondary outcomes:
measure: Numeric Pain Severity Scale after rTMS
timeFrame: Before rTMS, up to one day after finishing rTMS.
measure: Numeric Pain Severity Scale First Follow-up
timeFrame: Before rTMS, two weeks after finishing rTMS.
measure: Numeric Pain Severity Scale Second Follow-up
timeFrame: Before rTMS, four weeks after finishing rTMS.
measure: Neuropathic Pain Symptoms Inventory after rTMS
timeFrame: Before rTMS, up to one day after finishing rTMS.
measure: Neuropathic Pain Symptoms Inventory First Follow-up
timeFrame: Before rTMS, two weeks after finishing rTMS.
measure: Neuropathic Pain Symptoms Inventory Second Follow-up
timeFrame: Before rTMS, four weeks after finishing rTMS.
measure: Athens Insomnia Scale after rTMS
timeFrame: Before rTMS, up to one day after finishing rTMS.
measure: Athens Insomnia Scale First Follow-up
timeFrame: Before rTMS, two weeks after finishing rTMS.
measure: Athens Insomnia Scale Second Follow-up
timeFrame: Before rTMS, four weeks after finishing rTMS.
measure: Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS
timeFrame: Before rTMS, up to one day after finishing rTMS.
measure: Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up
timeFrame: Before rTMS, two weeks after finishing rTMS.
measure: Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up
timeFrame: Before rTMS, four weeks after finishing rTMS.
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Medical College
Study officials:
affiliation: Jagiellonian University
name: Tomasz Klupa, Professor
role: STUDY_CHAIR
References: