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

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480410
• Other study ID #: 013008028-2021-311
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: July 2022
• Source: Fundacion Universitaria Maria Cano
• Contact: Catalina Lopera, MSc
• Phone: + 57 3206728934
• Email: catalinaloperamuneton[@]fumc.edu.co
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

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

Locations

Country	Name	City	State
Colombia	CORTEX	Medellín	Antioquia

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Universitaria Maria Cano

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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