PainNCT06949618
Repetitive Transcranial Magnetic Stimulation in Cancer Pain Management
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Pain and Cancer, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have cancer pain symptoms, confirmed by a physician as cancer pain or neuropathic cancer pain
- Experienced the worst pain NRS score ≥ 4
- The patient demonstrate good cognition and is able to cooperate with the assessment of pain severity.
- The estimated survival time exceeds 3 months.
- Pre-existing bisphosphonate, chemotherapy, and hormonal therapy regimens remained unchanged throughout the study.
Who cannot join
- Individuals who have undergone head surgery or have metal implants in the head.
- Individuals with implanted cardiac pacemakers or cochlear prostheses.
- Have a history of epilepsy.
- Patients diagnosed with primary brain tumors or metastatic brain lesions.
- Present with additional neurological, psychiatric, or severe medical disorders.
- Individuals with metallic implants located in the cranial or cervical regions.
- Women who are pregnant.
- Presence of acute pain in any body region attributable to other medical conditions. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Medical University Hospital
Taipei, Taiwan, 110
Chien-Hung Lai, 0227372181 ext. 3242, chlai@tmu.edu.tw
About this study
Official title: Feasibility and Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Cancer Pain
Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated the effectiveness of remodeling neuroplasticity with repetitive transcranial magnetic stimulation (rTMS) to reduce cancer-related pain. To validate the use of rTMS in cancer-related pain, we plan to conduct a randomized controlled trial involving 30 cancer pain patients. Participants will be randomly assigned to receive either rTMS or sham rTMS treatment. Functional magnetic resonance imaging (fMRI) and pain index assessments will be conducted before and after the treatment to evaluate the outcomes.
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
Repetitive transcranial magnetic stimulation toward for cancer pain (real and sham control)
| Study group | Role | What they receive |
|---|---|---|
| Repetitive transcranial magnetic stimulation | Experimental | Not described Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Sham Repetitive transcranial magnetic stimulation | Sham comparator | Not described Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory, BPI
BPI is to assess the severity of pain and the impact of pain on daily functions, including Severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours.
Measured: Assess the BPI outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is a self-report measure used by patients with various diagnoses to assess pain. It consists of 78 words, from which respondents select those that best describe their pain experience. The words are categorized as follows:
Dimensions 1 to 10 (pain descriptors): 3 words
Dimensions 11 to 15 (affective components of pain): 3 words
Dimension 16 (evaluation of pain): 1 word
Dimensions 17 to 20 (miscellaneous): 1 word.
Scores are calculated by summing the values associated with each selected word, with scores ranging from 0 (no pain) to 78 (severe pain). Qualitative differences in pain are reflected in the respondent's word choices.
Measured: Assess MPQ scores before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Secondary outcomes (5)
Numerical Rating Scale, NRS
The Numeric Rating Scale (NRS) is commonly used to measure pain intensity and is well validated. It is scored from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable
Measured: Assess the NRS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Visual Analogue Scale , VAS
The Visual Analog Scale (VAS) is a validated, subjective measure of both acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum from 'no pain' to 'worst pain.'
Measured: Assess the VAS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Resting-state functional imaging, rsfMRI
In fMRI, by adding each pixel, the time course of a pixel is related to the average time course of the corresponding region of interest (ROI). In this context, the cross-correlation coefficient map for each seed ROI will be generated. This cross-correlation coefficient map will then undergo Fisher's z-transformation to approximate a normal distribution.
Measured: Assess the fMRI results before the intervention and after 2 weeks of interventions.
Beck Depression Inventory, BDI
BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each answer is being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
Measured: Assess the BDI scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
The 36-Item Short Form Survey quality of life
The 36-Item Short Form Survey (It comprises 36 questions that cover eight domains of health) is an outcome measure instrument that is often used, well-researched, self-reported measure of health. It comprises 36 questions that cover eight domains of health.
Measured: Assess the The SF-36 outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start20 May 2025 (estimated)
- Primary completion16 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949618
- Sponsor's protocol ID
- N202209046
- Status last verified
- Mar 2025
- First submitted
- 22 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Cancer Pain
- ClinicalTrials.gov ID
- NCT06949618
- Acronym / sponsor ID
- N202209046
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 20 May 2025 (estimated)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over half of cancer patients experience cancer-related pain. Despite advances in pain management with opioids, many patients continue to suffer from chronic cancer pain. The underlying mechanisms of cancer-related pain remain poorly understood, but they may be linked to brain neuroplasticity. As a result, some researchers suggest that targeting the motor cortex in cancer patients could improve pain management. However, few studies have investigated the effectiveness of remodeling neuroplasticity with repetitive transcranial magnetic stimulation (rTMS) to reduce cancer-related pain. To validate the use of rTMS in cancer-related pain, we plan to conduct a randomized controlled trial involving 30 cancer pain patients. Participants will be randomly assigned to receive either rTMS or sham rTMS treatment. Functional magnetic resonance imaging (fMRI) and pain index assessments will be conducted before and after the treatment to evaluate the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Sham Repetitive transcranial magnetic stimulation | Sham comparator | Device: Repetitive transcranial magnetic stimulation (rTMS) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients have cancer pain symptoms, confirmed by a physician as cancer pain or neuropathic cancer pain
- Experienced the worst pain NRS score ≥ 4
- The patient demonstrate good cognition and is able to cooperate with the assessment of pain severity.
- The estimated survival time exceeds 3 months.
- Pre-existing bisphosphonate, chemotherapy, and hormonal therapy regimens remained unchanged throughout the study.
Key exclusion criteria (8 listed)
- Individuals who have undergone head surgery or have metal implants in the head.
- Individuals with implanted cardiac pacemakers or cochlear prostheses.
- Have a history of epilepsy.
- Patients diagnosed with primary brain tumors or metastatic brain lesions.
- Present with additional neurological, psychiatric, or severe medical disorders.
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 stimulation (rTMS)Repetitive transcranial magnetic stimulation toward for cancer pain (real and sham control) | Device | Repetitive transcranial magnetic stimulation, Sham Repetitive transcranial magnetic stimulation |
Primary outcome
Brief Pain Inventory, BPI
Time frame: Assess the BPI outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
BPI is to assess the severity of pain and the impact of pain on daily functions, including Severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours.
McGill Pain Questionnaire
Time frame: Assess MPQ scores before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
The McGill Pain Questionnaire (MPQ) is a self-report measure used by patients with various diagnoses to assess pain. It consists of 78 words, from which respondents select those that best describe their pain experience. The words are categorized as follows: Dimensions 1 to 10 (pain descriptors): 3 words Dimensions 11 to 15 (affective components of pain): 3 words Dimension 16 (evaluation of pain): 1 word Dimensions 17 to 20 (miscellaneous): 1 word. Scores are calculated by summing the values associated with each selected word, with scores ranging from 0 (no pain) to 78 (severe pain). Qualitative differences in pain are reflected in the respondent's word choices.
5 secondary outcomes
Numerical Rating Scale, NRS
Time frame: Assess the NRS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Visual Analogue Scale , VAS
Time frame: Assess the VAS scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Resting-state functional imaging, rsfMRI
Time frame: Assess the fMRI results before the intervention and after 2 weeks of interventions.
Beck Depression Inventory, BDI
Time frame: Assess the BDI scale before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
The 36-Item Short Form Survey quality of life
Time frame: Assess the The SF-36 outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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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.
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 (rTMS) in people with Pain and Cancer, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 18 May 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chien-Hung Lai, MD, PhD (+886227372181 ext. 3242, chlai@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory, BPI (time frame: Assess the BPI outcome before the intervention, after 1 week and 2 weeks of intervention, as well as 1 week and 4 weeks after the intervention is completed.). 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?
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 18 May 2025.