Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295498
• Other study ID #: JagiellonianU69
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Jagiellonian University
• Contact: Jakub M Antczak, MD
• Phone: +48 795 421 153
• Email: jakub.antczak[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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.
• Sham repetitive transcranial magnetic stimulation
Sham stimulation to mimic the high frequency rTMS over the primary motor area.

Locations

Country	Name	City	State
Poland	Jagiellonian University Medical College	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
Jakub Antczak

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale of Pain Severity after rTMS	An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after finishing rTMS.	Through study completion, an average of 1 year.
Primary	Visual Analogue Scale of Pain Severity First Follow-up	An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after two weeks after finishing rTMS.	Before rTMS, up to one day after finishing rTMS.
Primary	Visual Analogue Scale of Pain Severity Second Follow-up	An analog scale of the length of 100 millimeter. Total score of 100, with higher scores representing more severe pain. Change from baseline score in the Visual Analogue Scale to the measurement taken after four weeks after finishing rTMS.	Before rTMS, four weeks after finishing rTMS.
Secondary	Numeric Pain Severity Scale after rTMS	Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken after finishing rTMS.	Before rTMS, up to one day after finishing rTMS.
Secondary	Numeric Pain Severity Scale First Follow-up	Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken two weeks after finishing rTMS.	Before rTMS, two weeks after finishing rTMS.
Secondary	Numeric Pain Severity Scale Second Follow-up	Total score 10, with higher scores representing more severe pain. Change from baseline score in the Numeric Pain Severity Scale to the measurement taken after four weeks after finishing rTMS.	Before rTMS, four weeks after finishing rTMS.
Secondary	Neuropathic Pain Symptoms Inventory after rTMS	Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken after finishing rTMS.	Before rTMS, up to one day after finishing rTMS.
Secondary	Neuropathic Pain Symptoms Inventory First Follow-up	Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken two weeks after finishing rTMS.	Before rTMS, two weeks after finishing rTMS.
Secondary	Neuropathic Pain Symptoms Inventory Second Follow-up	Total score 120, with higher scores representing more severe pain and other symptoms of neuropathy. Change from baseline score in the Neuropathic Pain Symptoms Inventory to the measurement taken four weeks after finishing rTMS.	Before rTMS, four weeks after finishing rTMS.
Secondary	Athens Insomnia Scale after rTMS	Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken after finishing rTMS.	Before rTMS, up to one day after finishing rTMS.
Secondary	Athens Insomnia Scale First Follow-up	Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken two weeks after finishing rTMS.	Before rTMS, two weeks after finishing rTMS.
Secondary	Athens Insomnia Scale Second Follow-up	Total score 24, with higher scores representing more severe insomnia. Change from baseline score in the Athens Insomnia Scale to the measurement taken four weeks after finishing rTMS.	Before rTMS, four weeks after finishing rTMS.
Secondary	Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS	Change from baseline strength of the foot extension to the measurement taken after finishing rTMS.	Before rTMS, up to one day after finishing rTMS.
Secondary	Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up	Change from baseline strength of the foot extension to the measurement taken two weeks after finishing rTMS.	Before rTMS, two weeks after finishing rTMS.
Secondary	Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up	Change from baseline strength of the foot extension to the measurement taken four weeks after finishing rTMS.	Before rTMS, four weeks after finishing rTMS.