Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation.
- Who it may be relevant to
- Registry conditions: Peripheral Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
Overview
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.
Interventions
- 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. - Device Sham repetitive transcranial magnetic stimulation
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
Primary outcome measures
- Visual Analogue Scale of Pain Severity after rTMS [Time frame: Through study completion, an average of 1 year.]
- Visual Analogue Scale of Pain Severity First Follow-up [Time frame: Before rTMS, up to one day after finishing rTMS.]
- Visual Analogue Scale of Pain Severity Second Follow-up [Time frame: Before rTMS, four weeks after finishing rTMS.]
Secondary outcome measures (12)
- 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.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Jagiellonian University Medical College — Krakow
Identifiers
NCT: NCT05295498 · JagiellonianU69