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

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

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 055421
      • CORTEX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active intervention; 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; 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; Other Names: rTMS

What is the study measuring?

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 1st month follow up and vs 3rd month follow up
Effect of Change of 20 rTMS Sessions on Pain and Functionality	Assessment of pain severity 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 1st month follow up and vs 3th month follow up

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) (0-100) higher number means a better quality of life	Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up

Collaborators and Investigators

• Sponsor: Fundacion Universitaria Maria Cano
• Investigators: Principal Investigator: Catalina Lopera, Msc, Fundación Universitaria María Cano

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2022
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Quality of life; Neuropathic pain; Transcranial Magnetic Stimulation, Repetitive
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: 013008028-2021-311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in oncological neuropathic pain. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication and the data will made accessible for up to 18 months. Extensions will be considered on a case-by-case basis
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact catalinaloperamuneton@fumc.edu.co
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; 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
• product manufactured in and exported from the U.S.: Yes