- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295498
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Neuropathic Pain
November 4, 2022 updated by: Jakub Antczak
Analgesic Effect of Accelerated Repetitive Transcranial Magnetic Stimulation in Pain Related to Peripheral Neuropathy
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jakub M Antczak, MD
- Phone Number: +48 795 421 153
- Email: jakub.antczak@uj.edu.pl
Study Contact Backup
- Name: Gabriela G Rusin, MD
- Phone Number: +48 601 661 607
- Email: gabriela.rusin@doctoral.uj.edu.pl
Study Locations
-
Poland
-
-
Kraków, Poland, 31008
- Recruiting
- Jagiellonian University Medical College
-
Contact:
- Jakub Antczak, MD
- Email: jakub.antczak@uj.edu.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Comparator: 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.
|
Sham stimulation to mimic the high frequency rTMS over the primary motor area.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale of Pain Severity after rTMS
Time Frame: Through study completion, an average of 1 year.
|
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.
|
Visual Analogue Scale of Pain Severity First Follow-up
Time Frame: Before rTMS, up to one day after finishing 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 two weeks after finishing rTMS.
|
Before rTMS, up to one day after finishing rTMS.
|
Visual Analogue Scale of Pain Severity Second Follow-up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
|
Before rTMS, four weeks after finishing rTMS.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Severity Scale after rTMS
Time Frame: Before rTMS, up to one day after finishing 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.
|
Numeric Pain Severity Scale First Follow-up
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
|
Before rTMS, two weeks after finishing rTMS.
|
Numeric Pain Severity Scale Second Follow-up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
|
Before rTMS, four weeks after finishing rTMS.
|
Neuropathic Pain Symptoms Inventory after rTMS
Time Frame: Before rTMS, up to one day after finishing 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.
|
Neuropathic Pain Symptoms Inventory First Follow-up
Time Frame: Before rTMS, two weeks after finishing 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 two weeks after finishing rTMS.
|
Before rTMS, two weeks after finishing rTMS.
|
Neuropathic Pain Symptoms Inventory Second Follow-up
Time Frame: Before rTMS, four weeks after finishing 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 four weeks after finishing rTMS.
|
Before rTMS, four weeks after finishing rTMS.
|
Athens Insomnia Scale after rTMS
Time Frame: Before rTMS, up to one day after finishing 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.
|
Athens Insomnia Scale First Follow-up
Time Frame: Before rTMS, two weeks after finishing rTMS.
|
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.
|
Athens Insomnia Scale Second Follow-up
Time Frame: Before rTMS, four weeks after finishing rTMS.
|
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.
|
Bilateral Dynamometric Assessment of the strength of the foot extension after rTMS
Time Frame: Before rTMS, up to one day after finishing 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.
|
Bilateral Dynamometric Assessment of the strength of the foot extension First Follow-up
Time Frame: Before rTMS, two weeks after finishing rTMS.
|
Change from baseline strength of the foot extension to the measurement taken two weeks after finishing rTMS.
|
Before rTMS, two weeks after finishing rTMS.
|
Bilateral Dynamometric Assessment of the strength of the foot extension Second Follow-up
Time Frame: Before rTMS, four weeks after finishing rTMS.
|
Change from baseline strength of the foot extension to the measurement taken four weeks after finishing rTMS.
|
Before rTMS, four weeks after finishing rTMS.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Tomasz Klupa, Professor, Jagiellonian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 4, 2022
Primary Completion (Anticipated)
March 31, 2024
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
March 7, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JagiellonianU69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
After completing the study, the age and gender of participants as well as the scores and results of all outcome measurements made at baseline, after rTMS, at the first and at the second follow-up will be made available to other researchers on request.
IPD Sharing Time Frame
The data will become available after the study results will be published.
IPD Sharing Access Criteria
On request sent by e-mail to jakub.antczak@uj.edu.pl
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Neuropathy
-
NCT06052345Not yet recruitingQuality of Life | Breast Cancer | Breast Neoplasms | Chemotherapy-induced Peripheral Neuropathy | Early-stage Breast Cancer | Non-Metastatic Breast Carcinoma | Polyneuropathy Due to Drugs | Polyneuropathy; Drug
-
NCT06048471RecruitingElectrical Stimulation | Chemotherapy-induced Peripheral Neuropathy
-
NCT06046287Not yet recruitingMonoclonal Gammopathy of Undetermined Significance | Peripheral Neuropathy
-
NCT06045013Recruiting
-
NCT06043141Not yet recruitingCarpal Tunnel Syndrome | Central Sensitisation
-
NCT06041360RecruitingAuditory Neuropathy Spectrum Disorder,, Peripheral Neuropathy
-
NCT06041399RecruitingDiabetic Peripheral Neuropathy
-
NCT06041412RecruitingDiabetic Peripheral Neuropathy
-
NCT06040840Not yet recruitingCarpal Tunnel Syndrome
-
NCT06040567Not yet recruitingPolyneuropathies | Diabetic Polyneuropathy | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | POEMS Syndrome | Multifocal Motor Neuropathy | Charcot-Marie-Tooth | hATTR Amyloidosis | Vasculitic Neuropathy | Idiopathic Neuropathy
Clinical Trials on Active repetitive transcranial magnetic stimulation
-
NCT05974202Not yet recruitingCocaine Use Disorder | Cocaine Dependence | Cocaine Use | Cocaine Use Disorder, Moderate | Cocaine Use Disorder, Severe
-
NCT05857761Not yet recruitingConcussion, Mild | Post-Traumatic Headache | MTBI - Mild Traumatic Brain Injury
-
NCT05724810Not yet recruitingSmoking Cessation | Schizophrenia | Tobacco Use
-
NCT05723588Not yet recruiting
-
NCT05651334Recruiting
-
NCT05599373RecruitingSchizophrenia | Cognitive Impairment | Repetitive Transcranial Magnetic Stimulation | Negative Symptoms in Schizophrenia | Dorsolateral Prefrontal Cortex
-
NCT04555278RecruitingChronic Low-back Pain
-
NCT03932773RecruitingPost Traumatic Stress Disorder