Neuropathic PainNCT05480410

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

A study testing Repetitive transcranial magnetic stimulation in people with Neuropathic Pain, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Neuropathic Pain
What is being tested?: Repetitive transcranial magnetic stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteColombia
Study dates: 11 Jun 2022to 23 Feb 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with neuropathic pain of oncological origin
Patients of legal age (18 years old)
Patients using their cognitive faculties

Who cannot join

Pregnancy
History of negative reaction to TMS
History of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

CORTEX
Medellín, Antioquia, 055421

Other trials in Colombia

About this study

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

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.

Read the 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.

Conditions: Neuropathic Pain
Being tested: Repetitive transcranial magnetic stimulation
Keywords: Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer
Medical subject headings: Neuralgia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Repetitive transcranial magnetic stimulationDevice
Also called rTMS
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

Study groups in NCT05480410
Study group	Role	What they receive
Active intervention	Experimental	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. Receives: Device: Repetitive transcranial magnetic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Assessment of Quality of life, measured by Functional Assessment of cancer Therapy (FACT-GOG- NTX 13) (0-100) higher number means a better quality of life
Measured: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 202223 Feb 2023

First posted29 Jul 2022
Study start11 Jun 2022
Primary completion30 Jan 2023
Study completion23 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neuropathic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A single group including patients with neuropathic oncological pain.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05480410
Sponsor's protocol ID: 013008028-2021-311
Status last verified: Jun 2025
First submitted: 10 Jun 2022
Last updated: 6 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial
ClinicalTrials.gov ID: NCT05480410
Acronym / sponsor ID: 013008028-2021-311
Conditions: Neuropathic Pain
Keywords: Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Fundacion Universitaria Maria CanoUniversity, hospital or other
Study start: 11 Jun 2022 (actual)
Primary completion: 30 Jan 2023 (actual)
Study completion: 23 Feb 2023 (actual)
First posted: 29 Jul 2022 (actual)
Results: Posted 6 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single group including patients with neuropathic oncological pain.

Arm	Type	Receives
Active intervention	Experimental	Device: Repetitive transcranial magnetic stimulationPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with neuropathic pain of oncological origin
Patients of legal age (18 years old)
Patients using their cognitive faculties

Key exclusion criteria (3 listed)

Pregnancy
History of negative reaction to TMS
History of seizure, history of epilepsy stroke, brain surgery and cranial metal implants.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Repetitive transcranial magnetic stimulationAlso: rTMSrTMS 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	Device	Active intervention

Primary outcome

Effect of Change of 20 rTMS Sessions on Pain
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up
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
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3th month follow up
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

1 secondary outcome

Effect of Change of 20 rTMS Sessions on Quality of Life
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up

Results and safety

Results posted to the registry on 6 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Intervention	10	10

Primary outcome: Effect of Change of 20 rTMS Sessions on Pain

Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Intervention n = 10
Day 1	5.53 (1.27)
Day 20	1.60 (1.47)
1st month follow up	1.97 (1.77)
3rd month follow up	3.48 (2.65)

Primary outcome: Effect of Change of 20 rTMS Sessions on Pain and Functionality

Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3th month follow up. Mean (Standard Deviation). Unit: score on a scale

Measure	Active Intervention n = 10
Day 1 Pain severity	5.53 (1.27)
Day 20 Pain severity	1.60 (1.47)
1st month follow up pain severity	1.97 (1.77)
3rd month follow up pain severity	3.48 (2.65)
Day 1 interference score	5.75 (1.58)
Day 20 interference score	0.73 (1.03)
1st month follow up interference score	2.01 (1.59)
3rd month follow up interference score	3.30 (2.27)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Intervention	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

Related trials for Neuropathic Pain

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catalina Lopera, Msc principal investigator

Fundacion Universitaria Maria Cano

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Repetitive transcranial magnetic stimulation in people with Neuropathic Pain, run by Fundacion Universitaria Maria Cano at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Change of 20 rTMS Sessions on Pain (time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05480410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.