Clinical trial NCT06949618: Repetitive Transcranial Magnetic Stimulation in Cancer Pain Management
Official title: Feasibility and Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Cancer
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Patients have cancer pain symptoms, confirmed by a physician as cancer pain or neuropathic cancer pain
2. Experienced the worst pain NRS score ≥ 4
3. The patient demonstrate good cognition and is able to cooperate with the assessment of pain severity.
4. The estimated survival time exceeds 3 months.
5. Pre-existing bisphosphonate, chemotherapy, and hormonal therapy regimens remained unchanged throughout the study.

Exclusion Criteria:

1. Individuals who have undergone head surgery or have metal implants in the head.
2. Individuals with implanted cardiac pacemakers or cochlear prostheses.
3. Have a history of epilepsy.
4. Patients diagnosed with primary brain tumors or metastatic brain lesions.
5. Present with additional neurological, psychiatric, or severe medical disorders.
6. Individuals with metallic implants located in the cranial or cervical regions.
7. Women who are pregnant.
8. Presence of acute pain in any body region attributable to other medical conditions. -

Primary outcomes:
measure: Brief Pain Inventory, BPI
timeFrame: 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.
measure: McGill Pain Questionnaire
timeFrame: 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:
measure: Numerical Rating Scale, NRS
timeFrame: 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.
measure: Visual Analogue Scale , VAS
timeFrame: 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.
measure: Resting-state functional imaging, rsfMRI
timeFrame: Assess the fMRI results before the intervention and after 2 weeks of interventions.
measure: Beck Depression Inventory, BDI
timeFrame: 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.
measure: The 36-Item Short Form Survey quality of life
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
References: