Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial
Phase: NA
Conditions: Neuropathic Pain
Sponsor: Fundacion Universitaria Maria Cano

 
 
 
 
 
 
 
 
 
 
 
Cover page study protocol 
 
 
 
Study Title: Application of transcranial magnetic stimulation treatment in patients with oncological 
neuropathic pain to evaluate effectiveness on pain and quality of life 
 
 
NCT number: 05480410 
 
 
 
 
Date of the document: 1/02/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study protocol  
The protocol will be structured according to the national institute of health, the statements 
described by the clinical trial database and the SPIRIT declaration, which include detailed study 
description and design, intervention, outcome measures and individual participant data and results 
sharing statement. 
 
10 patients will receive 20 sessions of transcranial magnetic stimulation using the MagVenture Mag 
Pro R20 device. These sessions will be conducted daily from Monday to Friday, lasting 20 minutes 
each, at an intensity of 81% with a motor threshold of 90 A/ns.  
 
A pre-post design without a control group will be used to evaluate 2 elements: pain and quality of 
life.  
The evaluation moments will be as follows: 
- Pretest: Quality of life and pain will be assessed using the Visual Analog Scale (VAS) and the Brief 
Pain Inventory (BPI). 
- Each session: Pain will be assessed using the VAS. 
- Each week: Pain will be assessed using the BPI. 
- Immediate Posttest: Quality of life and pain will be assessed using both scales. 
- Posttest at 1 month and 3 months: Quality of life and pain will be assessed using both scales. 
 
The patients will meet the following inclusion criteria: female or males aged over 18 and under 75 
years, any stage of cancer, chemotherapeutic treatment consisting of taxanos or oxaliplatin, 
neuropathic pain with a minimum grade 2 severity based on the National Cancer Institute Common 
Terminology Criteria for Adverse Events scale (NCI-CTCAE, version 5.0), and a mean 2 score or 
above in a visual analogue scale (VAS) of pain. We will exclude patients with any psychiatric disorder 
including major depression; history of seizure, epilepsy, stroke and intracranial metallic devices. 
Patients should agree to avoid any extra use of medication or to make any changes to their 
pharmacological plan during the trial.  
 
The aim of collecting these variables is to gather data and conduct statistical analysis to evaluate 
the effectiveness of transcranial magnetic stimulation on pain and quality of life in patients with 
neuropathic pain secondary to oncological treatment. 
 
TEST 1: Pain 
 
This symptom will be evaluated using the Visual Analog Scale for pain and the Brief Pain Inventory 
(BPI), questionnaires that have been previously used in oncology populations (Goto et al., 2020; 
Khedr et al., 2015). 
 
The Visual Analog Scale is rated from 0 to 10, where 0 indicates no pain and 10 represents the 
maximum pain. 
 
The Brief Pain Inventory allows patients to rate the severity of their pain and the extent to which 
their pain interferes with their functionality.  
 
 
 
 
 

An average is calculated for the elements that compose the pain severity category (worst pain, least 
pain, average pain, and current pain) and the elements that compose the pain interference category 
in functionality (interference in mood, walking, working, social interactions, sleeping, and 
enjoyment of life). Higher averages indicate worse patient condition. 
 
Test 2: Quality of Life 
 
Quality of life will be assessed using the Functional Assessment of Cancer Therapy FACT-GOG-NTX 
13 scale, which has been psychometrically analyzed and validated in oncology populations (Cheng 
et al., 2020).  
 
This scale includes 5 categories: 
- Physical Well-being 
- Social Well-being 
- Emotional Well-being 
- Functional Well-being 
- Neurotoxicity 
 
For scoring the scale, the ratings of these categories are summed, a higher total score means a 
better quality of life. 
 
Determination of resting motor threshold   
The target stimulation will be the primary motor cortex in its subdivision representing the hand; for 
this process, a basic trained operator identify the ‘omega-shape’ sulcus defining the Rolandic sulcus. 
Other authors have reported this specific hot spot target including the expert consensus established 
by a group of European experts, they described a Level A recommendation for the use of M1 as 
stimulation site for analgesic effect.  Then the accurate position of the target will be adjusted 
according to the amplitude of the motor response on the contralateral hand, which a basic rTMS-
trained physiotherapist will confirmed. This target has been shown in different investigations, to 
have greater specificity and effectiveness in the treatment of neuropathic pain. Once the target will 
be identified, it should be marked on a cap for the following sessions. A physiotherapist will be 
present weekly for assessment and to supervise patients’ responses to treatment.  
 
 
The occurrence of adverse events will be noted throughout the study period.  
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
Cover page Informed consent 
 
 
 
Study Title: Application of transcranial magnetic stimulation treatment in patients with oncological 
neuropathic pain to evaluate effectiveness on pain and quality of life 
 
 
NCT number: 05480410 
 
 
 
 
Date of the document: 1/02/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

INFORMED CONSENT 
 
 
Study Title: Application of transcranial magnetic stimulation treatment in patients with oncological 
neuropathic pain to evaluate effectiveness on pain and quality of life 
Project Code SIGP: 013008028-2021-311 
DATE:   
 
 
 
 
SUBJECT DETAILS 
Subject No. 
First Name 
Last Name 
Full name 
Identification 
document 
 
 
INFORMED CONSENT 
This document authorizes the application of transcranial magnetic therapy as a treatment for pain 
management in oncological patients, provided through a collaboration between Neuro Clínica 
CORTEX SAS and Fundación Universitaria María Cano. The purpose is to evaluate the effectiveness 
of transcranial magnetic stimulation intervention on pain and quality of life. 
A total of 20 sessions of Transcranial Magnetic Stimulation will be conducted using the 
MagVenture Mag Pro R20 equipment. The interventions will be supervised and evaluated through 
questions related to pain classification, description, functionality, ability to perform daily activities, 
and quality of life. These assessments will include pre-tests, after each session, immediate post- 
tests, and follow-ups at one month and three months post-intervention. Demographic and 
personal information will also be collected. Each session will last 20 minutes and will be conducted 
within a tolerance level of 81% with a motor threshold of 90 A/ns. 
Information provided by the patients will be stored electronically and physically. The volunteer may 
authorize or refuse participation in this intervention after understanding the benefits and risks 
explained below. 

GENERAL INFORMATION 
You have been invited to participate in a research study on the effectiveness of transcranial 
magnetic stimulation on pain and quality of life. 
Procedure 
In the first part of the study, you will be asked a series of questions about your daily activities, how 
you perform them, the duration of your pain experience, and how you describe and classify it. The 
interview and intervention will focus on pain management and its impact on your quality of life. 
Each session will last 20 minutes. 
Application of physiotherapy treatment protocol 
The focus will be on evaluating the effectiveness of transcranial magnetic therapy on neuropathic 
pain. 
Your decision to participate in this study is completely voluntary, and you may choose to continue 
or withdraw from the intervention or abstain from answering questions you do not wish to answer 
without penalty. If you choose not to complete the intervention, you may inform the researcher at 
any time. 
Confidentiality 
Your participation in this study is completely confidential, and the information provided will be 
analyzed under a unique identification number along with evaluations and interventions 
conducted on other patients, reported in aggregate form without mentioning personal or 
identifying information. Information collected in this study will be used for teaching, research, 
publications, or presentations at scientific events. 
Benefits 
While the research may not directly benefit you personally, nor provide any economic benefit for 
participating, the research findings may contribute to the development of alternatives in the 
treatment of oncological patients with neuropathic pain. The assessments and subsequent analysis 
will help address certain aspects impacting pain management and thus the quality of life of users. 
Risks associated with the Intervention 
As this is a quantitative study with a quasi-experimental, descriptive correlational design, pre-post 
without a control group, a standardized therapeutic protocol will be implemented to evaluate the 
effectiveness of transcranial magnetic therapy in reducing pain. According to Resolution No. 8430 
of 1993, the risk classification is minimal, given that the procedure is under evaluation and 
application of a treatment protocol. However, there may be mild headaches, dizziness, and/or 
drowsiness, which are manageable and only probable. 
Investigators 
At least one of the following investigators will be present during the intervention: 

Name 
Role 
Institution 
Catalina Lopera Muñetón 
Main investigator 
FUMC 
Isabel Cristina Ángel Bustos 
Dionis Vallejo Mesa 
Coinvestigador 
Investigador Externo 
FUMC 
Rosario clinic 
 
 
Contacts 
If you have any doubts, complaints, or suggestions about the project, you can contact the 
investigators at their respective emails: 
 
 
 
Investigator 
Phone 
Email 
Catalina 
Lopera 
Muñetón 
Isabel Cristina Ángel 
Bustos 
3206728934 
3146185960 
catalinaloperamuneton@fumc.edu.co 
Isabelcristinaangelbustos@fumc.edu.co 
 
 
 
VOLUNTARY CONSENT 
 
 
I,   
 
Identified with citizenship ID No.   
 
 
declare that I attend this session/intervention as an autonomous user, freely and voluntarily, 
exercising my faculties. Likewise, having been informed about the purposes, objectives, and 
procedures to be carried out during the project "Application of transcranial magnetic stimulation 
treatment in patients with oncological neuropathic pain to evaluate effectiveness on pain and 
quality of life," I authorize my participation in it and the use of the data obtained for academic and 
research purposes. 
 
 
Additionally, I am informed that: 
1. My participation in this research is completely voluntary, and I may withdraw at any time. 
2. I will not receive any financial benefit of any kind for participating in this project. The research 
results obtained may contribute to the development of alternatives for pain management and thus 
the quality of life of users. The assessments and subsequent analysis will help address certain 
aspects impacting the quality of life of users. 

3. All information obtained and research results will be treated confidentially. This information will 
be archived in paper and electronic format. Study files will be kept under the custody of the 
FISIOTER group of Fundación Universitaria María Cano, Neuro Clínica CORTEX, and the 
responsibility of its researchers. 
4. Since all information in this research project is anonymized, personal results cannot be made 
available to third parties such as family members, employers, governmental organizations, 
insurance companies, or other educational institutions. 
5. In case my personal data, photographs, and videos are required for events such as seminars, 
congresses, clinical case reviews, and publications, I authorize their use through the signing of this 
document. It is clarified that no individual identification data of participants will be presented. 
I certify that I have read and understood this entire document. Therefore, I confirm that I have 
been satisfactorily informed about the processes to be carried out by the professionals, and I give 
my consent. 
"I declare that I have not received verbal, written, and/or gestural pressures to participate in the 
study; that this decision was made in full use of my mental faculties, without being under the 
influence of medications, drugs, or alcohol, consciously, autonomously, and freely." 
 
 
[Signature]   
 
 
[Date]