Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
ConditionPeripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJakub Antczak
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active repetitive transcranial magnetic stimulation
DeviceHigh 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
DeviceSham stimulation to mimic the high frequency rTMS over the primary motor area.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Active repetitive transcranial magnetic stimulationExperimental treatment 1 intervention
Group B: Sham repetitive transcranial magnetic stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year.2
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.
Time frame
Before rTMS, up to one day after finishing rTMS.3
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.
Time frame
Before rTMS, four weeks after finishing rTMS.Secondary outcomes
1
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.
Time frame
Before rTMS, up to one day after finishing rTMS.2
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.
Time frame
Before rTMS, two weeks after finishing rTMS.3
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.
Time frame
Before rTMS, four weeks after finishing rTMS.4
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.
Time frame
Before rTMS, up to one day after finishing rTMS.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakub Antczak
Lead sponsor
Jagiellonian University
Sponsor institution
Source ClinicalTrials.gov