Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of Repetitive transcranial magnetic stimulation (rTMS) on pain and quality of life in patients with cancer neuropathic pain. Although there are currently different therapeutic options for neuropathic pain, most are limited or restricted to pharmacotherapy. Transcranial magnetic stimulation (TMS) is a tool recently incorporated into neuroscience in the management of neuropathic cancer pain. The study will include 10 patients with oncologic neuropathic pain who will receive 20 sessions of rTMS and the effect on pain and quality of life.

Detailed Description
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Neuropathic pain is defined as pain caused by a primary lesion or transient dysfunction of the central or peripheral nervous system. In cancer, it is generated as a consequence of multiple factors such as: direct compression of nerve structures, post-surgical nerve injuries, and nerve injuries secondary to chemotherapy. At least 3.5 million people around the world suffer from this symptom associated with cancer; Of this population, 38% experience pain in all stages and 80% in advanced stages, negatively impacting quality of life.

Official Title
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Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial

Conditions
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Neuropathic Pain

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with neuropathic pain of oncological origin Patients of legal age (18 years old) Patients using their cognitive faculties Exclusion Criteria: Pregnancy History of negative reaction to TMS History of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single group including patients with neuropathic oncological pain.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active intervention<br>Patients will receive 20 sessions of transcranial magnetic stimulation applied with the MagVenture Mag Pro R20 equipment, these sessions will be held daily from Monday to Friday, lasting 20 minutes at an intensity of 81% with a motor threshold of 90 A/ns. | Device: Repetitive transcranial magnetic stimulation<br>* rTMS is a minimal invasive technique which focus on the M1 cortex. It can stimulate the cortex by depolarizing superficial neurons. For this study we will use a MagVenture MagPro R20<br>* Other names: rTMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of change of 20 rTMS sessions on pain | Assessment of pain quantify by Visual analogue scale rated from 0-10, where 0 is the least pain and 10 the worst pain | Day 1 vs Day 20 vs Day 30 and vs Day 60 | 
| Effect of change of 20 rTMS sessions on pain and functionality | Assessment of pain and functionality quantify by brief pain inventory from 0-10, where 0 is the least pain and 10 the worst pain | Day 1 vs Day 20 vs Day 30 and vs Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of change of 20 rTMS sessions on quality of life | Assessment of Quality of life, measured by Functional Assessment of cancer Therapy (FACT-GOG- NTX 13) | Day 1 vs Day 20 vs Day 30 and vs Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer