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

Not Applicable

• Conditions: Neuropathic Pain
• Interventions: Device: Repetitive transcranial magnetic stimulation

• Registration Number: NCT05480410
• Lead Sponsor: Fundacion Universitaria Maria Cano

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.

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 Timeline

• Study First Submitted: 2022-06-10
• Study Start: 2022-06-11
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active intervention	Repetitive transcranial magnetic stimulation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CORTEX; 🇨🇴 Medellín, Antioquia, Colombia