Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

Jakub Antczak

Status: Enrolling

Conditions: Peripheral Neuropathy

Treatments: Device: Active repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05295498

JagiellonianU69

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Active repetitive transcranial magnetic stimulation

Experimental group

Description:

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.

Treatment:

Device: Active repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Sham repetitive transcranial magnetic stimulation