Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

NCT ID: NCT05295498

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2026-09-30

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.

Conditions

Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active repetitive transcranial magnetic stimulation

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.

Group Type: EXPERIMENTAL

Active repetitive transcranial magnetic stimulation

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham repetitive transcranial magnetic stimulation

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jakub Antczak

OTHER

Sponsor Role: lead

Responsible Party

Jakub Antczak

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tomasz Klupa, Professor

Role: STUDY_CHAIR

Jagiellonian University

Locations

Jagiellonian University Medical College

Krakow, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Jakub M Antczak, MD

Role: CONTACT

jakub.antczak@uj.edu.pl

+48 795 421 153

Gabriela G Rusin, MD

Role: CONTACT

gabriela.rusin@doctoral.uj.edu.pl

+48 601 661 607

Facility Contacts

Jakub Antczak, MD

Role: primary

jakub.antczak@uj.edu.pl

Other Identifiers

JagiellonianU69

Identifier Type: -

Identifier Source: org_study_id