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

NCT07151963 | Enrolling By Invitation

• 1 other identifier: 13-IRB009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.To compare the effects of pcTBS and 20 Hz rTMS on chemotherapy-induced peripheral neuropathy;
2. 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.

Conditions

Breast Cancer Females

Keywords

conventional repetitive transcranial magnetic stimulation; breast cancer; chemotherapy induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Depression Anxiety Stress Scale 21

  baseline and after completion the intervention and at 4 weeks follow-up

• pressure pain threshold test

  baseline and after completion the intervention and at 4 weeks follow-up

• Neuropathic Pain Symptom Inventory

  baseline and after completion the intervention and at 4 weeks follow-up

Study Arms (2)

prolonged continuous TBS (pcTBS)

EXPERIMENTAL

pcTBS over M1

Device: prolonged continuous TBS

20 Hz rTMS

ACTIVE COMPARATOR

20 Hz rTMS over M1

Device: 20 Hz rTMS

Interventions

prolonged continuous TBS DEVICE

prolonged continuous theta burst stimulation

prolonged continuous TBS (pcTBS)

20 Hz rTMS DEVICE

20 Hz repetitive transcranial magnetic stimulation

20 Hz rTMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• breast cancer patients aged between 18- and 80-years-old with CIPN
• history of receiving chemotherapy including taxane-based neurotoxic agents
• with neuropathic pain, score≥3 in a 0-10 VAS pain scale.
• with fair cognition and can cooperate to evaluate pain severity.
• neither at end-stage cancer nor at the estimated survival time less than 6 months.

You may not qualify if:

• brain tumor or history of epilepsy
• intracranial metallic devices, artificial cochleae, pacemakers, or any other metal device
• recent myocardial ischemia or unstable angina
• severe cognitive dysfunction or pregnancy
• injuries or fractures in the part of neuropathic pain

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yi-Shiung Horng, MD., PhD.

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 3, 2025
• Study Start: February 17, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)