CIPN - Chemotherapy-Induced Peripheral NeuropathyCIPN TBSNCT07695415
Network-Guided Theta Burst Stimulation for Breast Cancer With Chemotherapy-Induced Peripheral Neuropathy: Clinical and fMRI Biomarker Evidence
A study testing pcTBS in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Breast Cancer, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating complication among breast cancer survivors, frequently associated with chronic neuropathic pain that remains inadequately controlled by pharmacological treatments. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Breast Cancer
- What is being tested?
- pcTBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- breast cancer patients aged between 20- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Tzuchi Hospital
New Taipei City
Clinical Research Center, 886266289779, xd-clinical@tzuchi.com.tw
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating complication among breast cancer survivors, frequently associated with chronic neuropathic pain that remains inadequately controlled by pharmacological treatments. Emerging evidence suggests that CIPN pain is related to maladaptive reorganization of pain-related brain networks, highlighting the potential of non-pharmacological, brain-based neuromodulation strategies.
Among the variants of theta burst stimulation (TBS), both prolonged constant theta burst stimulation (pcTBS) and intermittent theta burst stimulation (iTBS) have facilitating effects of cortical excitability. The treatment time for pcTBS (1 min and 44 s, 1200 pulses) is much shorter than that of iTBS and traditional repetitive transcranial magnetic stimulation (rTMS); therefore, pcTBS seems to be a promising neuromodulation method for chronic pain and head-to-head comparison between pcTBS and iTBS has never been done before.
Read more
The aim of this two-year randomized, cross-over trial project is 1) to compare the effects of pcTBS and iTBS and determine the optimal TBS paradigm for alleviating CIPN pain a sequential focus on distinct cortical targets; 2) to implement a prospectively defined, network-guided framework using fMRI to characterize sensorimotor and pain-related brain connectivity and to examine whether baseline network features and stimulation-induced connectivity changes moderate clinical outcomes.
In Year 1, 20 breast cancer patients with CIPN will be recruited and randomly assigned to two groups: Group I will initially receive pcTBS over M1 for 5 consecutive days and then iTBS over M1 after a 8-week "wash-out" period. Group II will initially receive iTBS over M1 for 5 consecutive days and then pcTBS over M1 after a 8-week "wash-out" period. In year 2, the stimulation target will be changed to dorsolateral prefrontal cortex (DLPFC) to evaluate analgesic effects, and associated brain network changes related to cognitive-affective pain modulation.
MRI-based neuronavigation will be used to ensure precise and reproducible stimulation targeting. Both resting-state and task-based functional MRI will be acquired before stimulation and used prospectively to identify individualized pain-relevant cortical hotspots within predefined anatomical regions (M1 or DLPFC). Resting-state fMRI will be repeated within 24 hours after the final stimulation session to evaluate treatment-related changes in brain networks. Pain intensity measured by the visual analog scale will serve as the primary outcome, with secondary outcomes including Neuropathic Pain Symptom Inventory, Depression Anxiety Stress Scale 21 and pressure pain threshold testing. Primary and secondary outcomes will be evaluated immediately after the last stimulation session and again at 4-week follow-up.
By integrating a clinically efficient trial design with network-informed neuroimaging, this project is expected to provide target-specific evidence for TBS in CIPN pain and to establish a foundation for future precision-guided neuromodulation studies.
- Being tested
- pcTBS
- Keywords
- CIPN, breast cancer, theta burst stimulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pcTBSOther
Intermittent TBS (iTBS) applies 2 s of TBS trains repeated every 10 s for a total of 20 cycles (600 pulses, total 190 s) and increases cortical excitability for at least 20 min. pcTBS consisted of three pulses at 50 Hz (i.e., 60 ms) repeated 400 times at intervals of 200 ms (a total of 1,200 pulses in 1 min and 44 s)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I will initially receive pcTBS over M1 for 5 consecutive days and then iTBS over M1 after a 8-week "wash-out" period Receives: Other: pcTBS |
| Group 2 | Active comparator | Group II will initially receive iTBS over M1 for 5 consecutive days and then pcTBS over M1 after a 8-week "wash-out" period Receives: Other: pcTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue pain scale (VAS)
Patients will be instructed to rate their mean daily pain on a 0-100 visual analogue pain scale (VAS).
Measured: before the first and after the fifth rTMS session in each treatment period
Secondary outcomes (1)
Neuropathic Pain Symptom Inventory
NPSI is comprised of five subscales for assessing the diverse symptoms of neuropathic pain, including burning spontaneous pain (burning), pressing spontaneous pain (pressing), paroxysmal pain (paroxysmal), evoked pain (evoked), and paresthesia/dysesthesia.
Measured: before and after 5-day treatment section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695415
- Sponsor's protocol ID
- 15-IRB011
- Acronym
- CIPN TBS
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-Guided Theta Burst Stimulation for Breast Cancer With Chemotherapy-Induced Peripheral Neuropathy: Clinical and fMRI Biomarker Evidence
- ClinicalTrials.gov ID
- NCT07695415
- Acronym / sponsor ID
- CIPN TBS / 15-IRB011
- Keywords
- CIPN, breast cancer, theta burst stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating complication among breast cancer survivors, frequently associated with chronic neuropathic pain that remains inadequately controlled by pharmacological treatments. Emerging evidence suggests that CIPN pain is related to maladaptive reorganization of pain-related brain networks, highlighting the potential of non-pharmacological, brain-based neuromodulation strategies.
Among the variants of theta burst stimulation (TBS), both prolonged constant theta burst stimulation (pcTBS) and intermittent theta burst stimulation (iTBS) have facilitating effects of cortical excitability. The treatment time for pcTBS (1 min and 44 s, 1200 pulses) is much shorter than that of iTBS and traditional repetitive transcranial magnetic stimulation (rTMS); therefore, pcTBS seems to be a promising neuromodulation method for chronic pain and head-to-head comparison between pcTBS and iTBS has never been done before.
The aim of this two-year randomized, cross-over trial project is 1) to compare the effects of pcTBS and iTBS and determine the optimal TBS paradigm for alleviating CIPN pain a sequential focus on distinct cortical targets; 2) to implement a prospectively defined, network-guided framework using fMRI to characterize sensorimotor and pain-related brain connectivity and to examine whether baseline network features and stimulation-induced connectivity changes moderate clinical outcomes.
In Year 1, 20 breast cancer patients with CIPN will be recruited and randomly assigned to two groups: Group I will initially receive pcTBS over M1 for 5 consecutive days and then iTBS over M1 after a 8-week "wash-out" period. Group II will initially receive iTBS over M1 for 5 consecutive days and then pcTBS over M1 after a 8-week "wash-out" period. In year 2, the stimulation target will be changed to dorsolateral prefrontal cortex (DLPFC) to evaluate analgesic effects, and associated brain network changes related to cognitive-affective pain modulation.
MRI-based neuronavigation will be used to ensure precise and reproducible stimulation targeting. Both resting-state and task-based functional MRI will be acquired before stimulation and used prospectively to identify individualized pain-relevant cortical hotspots within predefined anatomical regions (M1 or DLPFC). Resting-state fMRI will be repeated within 24 hours after the final stimulation session to evaluate treatment-related changes in brain networks. Pain intensity measured by the visual analog scale will serve as the primary outcome, with secondary outcomes including Neuropathic Pain Symptom Inventory, Depression Anxiety Stress Scale 21 and pressure pain threshold testing. Primary and secondary outcomes will be evaluated immediately after the last stimulation session and again at 4-week follow-up.
By integrating a clinically efficient trial design with network-informed neuroimaging, this project is expected to provide target-specific evidence for TBS in CIPN pain and to establish a foundation for future precision-guided neuromodulation studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: pcTBSGroup I will initially receive pcTBS over M1 for 5 consecutive days and then iTBS over M1 after a 8-week "wash-out" period |
| Group 2 | Active comparator | Other: pcTBSGroup II will initially receive iTBS over M1 for 5 consecutive days and then pcTBS over M1 after a 8-week "wash-out" period |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- breast cancer patients aged between 20- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pcTBSIntermittent TBS (iTBS) applies 2 s of TBS trains repeated every 10 s for a total of 20 cycles (600 pulses, total 190 s) and increases cortical excitability for at least 20 min. pcTBS consisted of three pulses at 50 Hz (i.e., 60 ms) repeated 400 times at intervals of 200 ms (a total of 1,200 pulses in 1 min and 44 s) | Other | Group 2, Group I |
Primary outcome
Visual analogue pain scale (VAS)
Time frame: before the first and after the fifth rTMS session in each treatment period
Patients will be instructed to rate their mean daily pain on a 0-100 visual analogue pain scale (VAS).
1 secondary outcome
Neuropathic Pain Symptom Inventory
Time frame: before and after 5-day treatment section
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- doi: 10.1177/20503121231209088Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pcTBS in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Breast Cancer, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi-shiung Horng, MD., PhD. (886-2-66289779, yshorng2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue pain scale (VAS) (time frame: before the first and after the fifth rTMS session in each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.