Repetitive Transcranial Magnetic Stimulation in Cancer Pain Management

NCT06949618 | Not Yet Recruiting DMC

• 1 other identifier: N202209046
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  Assess the fMRI results before the intervention and after 2 weeks of interventions.

• Beck Depression Inventory, BDI

  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

  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.

Study Arms (2)

Repetitive transcranial magnetic stimulation

EXPERIMENTAL

Device: Repetitive transcranial magnetic stimulation (rTMS)

Sham Repetitive transcranial magnetic stimulation

SHAM COMPARATOR

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) DEVICE

Repetitive transcranial magnetic stimulation toward for cancer pain (real and sham control)

Repetitive transcranial magnetic stimulation; Sham Repetitive transcranial magnetic stimulation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, Taiwan, 110, Taiwan

Location

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Chien-Hung Lai, MD, PhD

CONTACT

+886227372181; chlai@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)