Neuropathic Pain
Conditions
Keywords
Transcranial Magnetic Stimulation, Repetitive, Neuropathic pain, Quality of life, Cancer
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.
Interventions
DEVICERepetitive 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
Sponsors
Fundacion Universitaria Maria Cano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single group including patients with neuropathic oncological pain.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Change of 20 rTMS Sessions on Pain | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Change of 20 rTMS Sessions on Quality of Life | Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up | 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 |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Active Intervention | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 52.4 years STANDARD_DEVIATION 12.6 | — |
| Body mass index | 30.1 kg/m^2 STANDARD_DEVIATION 5.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 1 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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
Time frame: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain | Day 1 | 5.53 score on a scale | Standard Deviation 1.27 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain | 1st month follow up | 1.97 score on a scale | Standard Deviation 1.77 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain | 3rd month follow up | 3.48 score on a scale | Standard Deviation 2.65 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain | Day 20 | 1.60 score on a scale | Standard Deviation 1.47 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | Day 1 Pain severity | 5.53 score on a scale | Standard Deviation 1.27 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | Day 20 Pain severity | 1.60 score on a scale | Standard Deviation 1.47 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | 1st month follow up pain severity | 1.97 score on a scale | Standard Deviation 1.77 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | 3rd month follow up pain severity | 3.48 score on a scale | Standard Deviation 2.65 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | Day 1 interference score | 5.75 score on a scale | Standard Deviation 1.58 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | Day 20 interference score | 0.73 score on a scale | Standard Deviation 1.03 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | 1st month follow up interference score | 2.01 score on a scale | Standard Deviation 1.59 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Pain and Functionality | 3rd month follow up interference score | 3.30 score on a scale | Standard Deviation 2.27 |
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) (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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Intervention | Effect of Change of 20 rTMS Sessions on Quality of Life | 1st month follow up FACT total score | 85.10 score on a scale | Standard Deviation 15.08 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Quality of Life | Day 1 FACT Total score | 68.90 score on a scale | Standard Deviation 7.62 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Quality of Life | Day 20 FACT total score | 91.00 score on a scale | Standard Deviation 9.23 |
| Active Intervention | Effect of Change of 20 rTMS Sessions on Quality of Life | 3rd month follow up FACT total score | 79.50 score on a scale | Standard Deviation 16.9 |