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

Sponsor
Fundacion Universitaria Maria Cano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05480410
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
7.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Repetitive transcranial magnetic stimulation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single group including patients with neuropathic oncological pain.A single group including patients with neuropathic oncological pain.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial
Actual Study Start Date :
Jun 11, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jan 30, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    Secondary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CORTEX Medellín Antioquia Colombia 055421

    Sponsors and Collaborators

    • Fundacion Universitaria Maria Cano

    Investigators

    • Principal Investigator: Catalina Lopera, Msc, Fundacion Universitaria Maria Cano

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Catalina Lopera Muñetón, Associate Professor, Fundacion Universitaria Maria Cano
    ClinicalTrials.gov Identifier:
    NCT05480410
    Other Study ID Numbers:
    • 013008028-2021-311
    First Posted:
    Jul 29, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Catalina Lopera Muñetón, Associate Professor, Fundacion Universitaria Maria Cano
    Transcranial Magnetic Stimulation, Repetitive
    Neuropathic pain
    Quality of life
    Cancer
    Additional relevant MeSH terms:
    Neuralgia

    Study Results

    No Results Posted as of Jul 29, 2022