Trial Outcomes & Findings for Effectiveness of rTMS on Pain and Quality of Life in Patients With Cancer Neuropathic Pain. Clinical Trial. (NCT NCT05480410)
NCT ID: NCT05480410
Last Updated: 2025-06-06
Results Overview
Assessment of pain quantify by Visual analogue scale rated from 0-10, where 0 is the least pain and 10 the worst pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow up
Results posted on
2025-06-06
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
|
10
|
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Intervention
n=10 Participants
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
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=10 Participants
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Age, Categorical
Between 18 and 65 years
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8 Participants
n=10 Participants
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Age, Categorical
>=65 years
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2 Participants
n=10 Participants
|
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Age, Continuous
|
52.4 years
STANDARD_DEVIATION 12.6 • n=10 Participants
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Sex: Female, Male
Female
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9 Participants
n=10 Participants
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Sex: Female, Male
Male
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1 Participants
n=10 Participants
|
|
Body mass index
|
30.1 kg/m^2
STANDARD_DEVIATION 5.5 • n=10 Participants
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PRIMARY outcome
Timeframe: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow upAssessment of pain quantify by Visual analogue scale rated from 0-10, where 0 is the least pain and 10 the worst pain
Outcome measures
| Measure |
Active Intervention
n=10 Participants
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
|
|---|---|
|
Effect of Change of 20 rTMS Sessions on Pain
Day 1
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5.53 score on a scale
Standard Deviation 1.27
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|
Effect of Change of 20 rTMS Sessions on Pain
Day 20
|
1.60 score on a scale
Standard Deviation 1.47
|
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Effect of Change of 20 rTMS Sessions on Pain
1st month follow up
|
1.97 score on a scale
Standard Deviation 1.77
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Effect of Change of 20 rTMS Sessions on Pain
3rd month follow up
|
3.48 score on a scale
Standard Deviation 2.65
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PRIMARY outcome
Timeframe: Day 1 vs Day 20 vs 1st month follow up and vs 3th month follow upAssessment of pain severity and functionality quantify by brief pain inventory from 0-10, where 0 is the least pain and 10 the worst pain
Outcome measures
| Measure |
Active Intervention
n=10 Participants
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
|
|---|---|
|
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
|
|
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
|
|
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
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Effect of Change of 20 rTMS Sessions on Pain and Functionality
3rd month follow up pain severity
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3.48 score on a scale
Standard Deviation 2.65
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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
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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
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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
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Effect of Change of 20 rTMS Sessions on Pain and Functionality
3rd month follow up interference score
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3.30 score on a scale
Standard Deviation 2.27
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SECONDARY outcome
Timeframe: Day 1 vs Day 20 vs 1st month follow up and vs 3rd month follow upAssessment 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
Outcome measures
| Measure |
Active Intervention
n=10 Participants
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
|
|---|---|
|
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
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Effect of Change of 20 rTMS Sessions on Quality of Life
3rd month follow up FACT total score
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79.50 score on a scale
Standard Deviation 16.90
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Effect of Change of 20 rTMS Sessions on Quality of Life
Day 1 FACT Total score
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68.90 score on a scale
Standard Deviation 7.62
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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
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Adverse Events
Active Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Intervention
n=10 participants at risk
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
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|---|---|
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Nervous system disorders
drowsiness
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10.0%
1/10 • Number of events 1 • 3 months
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Nervous system disorders
Mild headache
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10.0%
1/10 • Number of events 1 • 3 months
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Additional Information
Physiotherapy professor
Fundación Universitaria María Cano
Phone: +573206728934
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place