An interventional study of Repetitive transcranial magnetic stimulation in Neuropathic Pain, sponsored by Fundacion Universitaria Maria Cano. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Fundacion Universitaria Maria Cano · Not applicable, Interventional, and Treatment
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.
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.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's enrollment of 10 is below the median of 52 across 831 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Fundacion Universitaria Maria Cano is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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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
Also known as: rTMS
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
Time frame: 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
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3th month follow up
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
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up
| Milestone | Active Intervention |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Assessment of pain quantify by Visual analogue scale rated from 0-10, where 0 is the least pain and 10 the worst pain
| score on a scale | Active Intervention |
|---|---|
| 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 |
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
| score on a scale | Active Intervention |
|---|---|
| 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 |
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
| score on a scale | Active Intervention |
|---|---|
| Day 1 FACT Total score | 68.90 ± 7.62 |
| Day 20 FACT total score | 91.00 ± 9.23 |
| 1st month follow up FACT total score | 85.10 ± 15.08 |
| 3rd month follow up FACT total score | 79.50 ± 16.90 |
Collected over 3 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Intervention | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Active Intervention |
|---|---|
| drowsinessNervous system disorders | 1/10 |
| Mild headacheNervous system disorders | 1/10 |
| Age, Categorical(Participants) | Active Intervention |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 2 |
| Age, Continuous(years) | Active Intervention |
|---|---|
| Mean | 52.4 ± 12.6 |
| Sex: Female, Male(Participants) | Active Intervention |
|---|---|
| Female | 9 |
| Male | 1 |
| Race and Ethnicity Not Collected(Participants) | Active Intervention |
|---|
| Body mass index(kg/m^2) | Active Intervention |
|---|---|
| Mean | 30.1 ± 5.5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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
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
Ran from Jun 2022 to primary completion in Jan 2023, 7 months.
Results were first posted in Jun 2025, 2 years 4 months after primary completion.
Of 246 non-industry interventional studies with no phase under Neuralgia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 7 months is below that.
Counting every sponsor, half of 264 studies reached it within 24 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Fundacion Universitaria Maria Cano