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

Not Applicable

• Conditions: Breast Cancer Females

• Registration Number: NCT07151963
• Lead Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Brief 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:\*\* We 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.

Study Timeline

• Study Start: 2025-02-17
• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• a. breast cancer patients aged between 18- and 80-years-old with CIPN

  b. history of receiving chemotherapy including taxane-based neurotoxic agents

  c. with neuropathic pain, score≥3 in a 0-10 VAS pain scale.

  d. with fair cognition and can cooperate to evaluate pain severity.

  e. neither at end-stage cancer nor at the estimated survival time less than 6 months.

Exclusion Criteria

1. brain tumor or history of epilepsy

2. intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device

3. recent myocardial ischemia or unstable angina

4. severe cognitive dysfunction or pregnancy

5. injuries or fractures in the part of neuropathic pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
visual analogue pain scale (VAS pain scale)	baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up	visual analogue pain scale (VAS) range from 0-100, with a higher score inducating more pain

Secondary Outcome Measures

Name	Time	Method
Depression Anxiety Stress Scale 21	baseline and after completion the intervention and at 4 weeks follow-up	Depression Anxiety Stress Scale 21 scale ranges from 0-63, with a higher scores mean a worse outcome.
pressure pain threshold test	baseline and after completion the intervention and at 4 weeks follow-up	o Higher pressure pain threshold values indicate a higher tolerance to pressure pain (less sensitivity).
Neuropathic Pain Symptom Inventory	baseline and after completion the intervention and at 4 weeks follow-up	Neuropathic Pain Symptom Inventory ranges from zero to 10, with zero indicating no pain at all and 10 indicating the worst imaginable pain.

Trial Locations

Locations (1)

Taipei Tzu Chi Hospital; 🇨🇳 New Taipei City, Taiwan