NCT07151963

Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy

Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy: a Randomized Cross- Over Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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: 1. To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy; 2. To compare the effects of pcTBS applied to the primary motor cortex versus the dorsolateral prefrontal cortex on neuropathic pain as well as depression and anxiety.

Detailed description

\*\*Phase 1:\*\* Investigators will recruit 20 breast cancer patients who have chemotherapy-induced peripheral neuropathy. They will be randomly divided into two groups. * Group 1 will first receive pcTBS. After an 8-week break, they will then receive 20 Hz rTMS. * Group 2 will receive the treatments in the opposite order. 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.

Conditions

• Breast Cancer Females

Interventions

Type	Name	Description
DEVICE	prolonged continuous TBS	prolonged continuous theta burst stimulation
DEVICE	20 Hz rTMS	20 Hz repetitive transcranial magnetic stimulation

Timeline

• Start date: 2025-02-17
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-09-03
• Last updated: 2025-09-11

Locations

1 site across 1 country: Taiwan