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
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2022
CompletedStudy Start
First participant enrolled
June 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedResults Posted
Study results publicly available
June 6, 2025
CompletedJune 6, 2025
June 1, 2025
8 months
June 10, 2022
April 20, 2023
June 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Effect of Change of 20 rTMS Sessions on Quality of Life
Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up
Study Arms (1)
Active intervention
EXPERIMENTALPatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- Patients with neuropathic pain of oncological origin
- Patients of legal age (18 years old)
- Patients using their cognitive faculties
You may not qualify if:
- Pregnancy
- History of negative reaction to TMS
- History of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CORTEX
Medellín, Antioquia, 055421, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations in the interpretation of our results include the small sample size of this pilot study, the lack of a sham stimulation group. Future research with longer follow up could support the inclusion of rTMS as a therapeutic option for comprehensive oncology rehabilitation programs.
Results Point of Contact
- Title
- Physiotherapy professor
- Organization
- Fundación Universitaria María Cano
Study Officials
- PRINCIPAL INVESTIGATOR
Catalina Lopera, Msc
Fundacion Universitaria Maria Cano
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 10, 2022
First Posted
July 29, 2022
Study Start
June 11, 2022
Primary Completion
January 30, 2023
Study Completion
February 23, 2023
Last Updated
June 6, 2025
Results First Posted
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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
- 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
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.