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Laboratory studies have shown that prolonged continuous theta burst stimulation (pcTBS) provides better pain relief than 10 Hz repetitive transcranial magnetic stimulation (rTMS), with a shorter stimulation time, making it more practical for clinical use. Chemotherapy-induced peripheral neuropathy often causes neuropathic pain in cancer patients. The aims of this study are:
**Phase 1:** Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups.
Each treatment lasts for 5 consecutive days. Before and after each treatment, patients will be assessed using:
A pain visual analog scale (to measure pain levels)
A Neuropathic Pain Symptom Inventory (The scale ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain)
• * A Depression Anxiety Stress Scale 21 (The scale ranges from 0-63, with a higher scores mean a worse outcome)
o * Clinical pressure pain threshold tests (Higher PPT values indicate a higher tolerance to pressure pain (less sensitivity).
Nerve conduction studies **Phase 2:** Another 20 breast cancer patients with chemotherapy-induced peripheral neuropathy will be recruited and randomly divided into two groups.
Group 1 will first receive pcTBS on the primary motor cortex. After an 8-week break, they will receive the same stimulation on the left dorsolateral prefrontal cortex.
Group 2 will receive the treatments in the opposite order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prolonged continuous TBS (pcTBS) | Experimental | pcTBS over M1 |
|
| 20 Hz rTMS | Active Comparator | 20 Hz rTMS over M1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prolonged continuous TBS | Device | prolonged continuous theta burst stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue pain scale (VAS pain scale) | visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain | baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Depression Anxiety Stress Scale 21 | Depression Anxiety Stress Scale 21 scale ranges from 0-63, with a higher scores mean a worse outcome. | baseline and after completion the intervention and at 4 weeks follow-up |
| pressure pain threshold test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Shiung Horng, MD., PhD. | Taichung Tzu Chi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | New Taipei City | Taiwan |
confidential data
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 20 Hz rTMS | Device | 20 Hz repetitive transcranial magnetic stimulation |
|
o Higher pressure pain threshold values indicate a higher tolerance to pressure pain (less sensitivity).
| baseline and after completion the intervention and at 4 weeks follow-up |
| Neuropathic Pain Symptom Inventory | Neuropathic Pain Symptom Inventory ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain. | baseline and after completion the intervention and at 4 weeks follow-up |
| D017437 |
| Skin and Connective Tissue Diseases |