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

Buddhist Tzu Chi Medical Foundation

Status

Invitation-only

Conditions

Breast Cancer Females

Treatments

Device: 20 Hz rTMS

Device: prolonged continuous TBS

Study type

Interventional

Funder types

Other

Identifiers

NCT07151963

13-IRB009

Details and patient eligibility

About

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:

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

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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