Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: prolonged continuous TBS, 20 Hz rTMS.
- Who it may be relevant to
- Registry conditions: Breast Cancer Females. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Prolonged Continuous Theta Burst Stimulation in Chemotherapy-induced Peripheral Neuropathy: a Randomized Cross- Over Trial
Overview
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.
Interventions
- Device prolonged continuous TBS
prolonged continuous theta burst stimulation - Device 20 Hz rTMS
20 Hz repetitive transcranial magnetic stimulation
Primary outcome measures
- visual analogue pain scale (VAS pain scale) [Time frame: baseline, pre-intervention and immediately after completion the intervention and at 4 weeks follow-up]
Secondary outcome measures (3)
- Depression Anxiety Stress Scale 21 [Time frame: baseline and after completion the intervention and at 4 weeks follow-up]
- pressure pain threshold test [Time frame: baseline and after completion the intervention and at 4 weeks follow-up]
- Neuropathic Pain Symptom Inventory [Time frame: baseline and after completion the intervention and at 4 weeks follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Taipei Tzu Chi Hospital — New Taipei City
Identifiers
NCT: NCT07151963 · 13-IRB009