Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial.
Primary Purpose
Neuropathic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer
Eligibility Criteria
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.
Sites / Locations
- CORTEXRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05480410
First Posted
June 10, 2022
Last Updated
July 27, 2022
Sponsor
Fundacion Universitaria Maria Cano
1. Study Identification
Unique Protocol Identification Number
NCT05480410
Brief Title
Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Universitaria Maria Cano
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single group including patients with neuropathic oncological pain.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS
Intervention Description
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
Primary Outcome Measure Information:
Title
Effect of change of 20 rTMS sessions on pain
Description
Assessment of pain quantify by Visual analogue scale rated from 0-10, where 0 is the least pain and 10 the worst pain
Time Frame
Day 1 vs Day 20 vs Day 30 and vs Day 60
Title
Effect of change of 20 rTMS sessions on pain and functionality
Description
Assessment of pain and functionality quantify by brief pain inventory from 0-10, where 0 is the least pain and 10 the worst pain
Time Frame
Day 1 vs Day 20 vs Day 30 and vs Day 60
Secondary Outcome Measure Information:
Title
Effect of change of 20 rTMS sessions on quality of life
Description
Assessment of Quality of life, measured by Functional Assessment of cancer Therapy (FACT-GOG- NTX 13)
Time Frame
Day 1 vs Day 20 vs Day 30 and vs Day 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catalina Lopera, MSc
Phone
+ 57 3206728934
Email
catalinaloperamuneton@fumc.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Isabel Angel, MSc
Phone
+573146185960
Email
isabelcristinaangelbustos@fumc.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catalina Lopera, Msc
Organizational Affiliation
Fundacion Universitaria Maria Cano
Official's Role
Principal Investigator
Facility Information:
Facility Name
CORTEX
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
055421
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catalina Lopera, MSc
Phone
+573206728934
Email
catalinaloperamuneton@fumc.edu.co
First Name & Middle Initial & Last Name & Degree
Isabel Angel, MSc
Phone
3146185960
Email
isabelcristinaangelbustos@fumc.edu.co
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial.
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