Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

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

Sponsors

Lead Sponsor: Jakub Antczak

Source Jagiellonian University
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.

Overall Status Not yet recruiting
Start Date 2022-06-05
Completion Date 2024-09-30
Primary Completion Date 2024-03-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Visual Analogue Scale of Pain Severity after rTMS Through study completion, an average of 1 year.
Visual Analogue Scale of Pain Severity First Follow-up Before rTMS, up to one day after finishing rTMS.
Visual Analogue Scale of Pain Severity Second Follow-up Before rTMS, four weeks after finishing rTMS.
Secondary Outcome
Measure Time Frame
Numeric Pain Severity Scale after rTMS Before rTMS, up to one day after finishing rTMS.
Numeric Pain Severity Scale First Follow-up Before rTMS, two weeks after finishing rTMS.
Numeric Pain Severity Scale Second Follow-up Before rTMS, four weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory after rTMS Before rTMS, up to one day after finishing rTMS.
Neuropathic Pain Symptoms Inventory First Follow-up Before rTMS, two weeks after finishing rTMS.
Neuropathic Pain Symptoms Inventory Second Follow-up Before rTMS, four weeks after finishing rTMS.
Athens Insomnia Scale after rTMS Before rTMS, up to one day after finishing rTMS.
Athens Insomnia Scale First Follow-up Before rTMS, two weeks after finishing rTMS.
Athens Insomnia Scale Second Follow-up Before rTMS, four weeks after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS Before rTMS, up to one day after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up Before rTMS, two weeks after finishing rTMS.
Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up Before rTMS, four weeks after finishing rTMS.
Enrollment 70
Condition
Intervention

Intervention Type: Device

Intervention Name: Active repetitive transcranial magnetic stimulation

Description: High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.

Arm Group Label: Active repetitive transcranial magnetic stimulation

Intervention Type: Device

Intervention Name: Sham repetitive transcranial magnetic stimulation

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

Arm Group Label: Sham repetitive transcranial magnetic stimulation

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Tomasz Klupa, Professor Study Chair Jagiellonian University
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Contact: Jagiellonian University Medical College Jakub Antczak, MD [email protected]
Location Countries

Poland

Verification Date

2022-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Jagiellonian University

Investigator Full Name: Jakub Antczak

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Active repetitive transcranial magnetic stimulation

Type: Experimental

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.

Label: Sham repetitive transcranial magnetic stimulation

Type: Sham Comparator

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.

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Parallel Assignment. Patients will be randomly assigned to active or to sham stimulation.

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking Description: Triple (Participant, Investigator, Outcomes Assessor). Sham stimulation will be provided by holding the stimulating coil perpendicularly to the scalp, which assures similar impression as during active stimulation but prevents significant magnetic field to reach the brain tissue.

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