Accelerated intermittent theta burst stimulation for neuropathic pain

Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain

This project will try accelerated intermittent theta burst stimulation (a rapid form of rTMS) versus standard 10‑Hz rTMS to reduce neuropathic pain in adults with peripheral neuropathy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07148388 on ClinicalTrials.gov

What this trial studies

This randomized interventional study compares an accelerated intermittent theta burst stimulation (AiTBS) schedule to conventional 10‑Hz repetitive TMS applied to the left primary motor cortex for adults with peripheral neuropathic pain. Participants are randomly assigned to either an AiTBS arm (up to six sessions per day across five days within ten days) or ten consecutive days of standard 10‑Hz rTMS. Clinical pain measures and neurophysiological recordings of corticospinal excitability using TMS‑EEG are collected at baseline and after the final treatment session. The trial was designed as the first repeated‑session therapeutic test of AiTBS in this patient population to compare analgesic magnitude and cortical excitability changes against standard rTMS.

Who should consider this trial

Good fit: Adults (18+) with an IASP diagnosis of peripheral neuropathic pain for at least three months, moderate or worse pain (≥3 on VAS/NRS), stable medical therapy, and no contraindications to TMS.

Not a fit: Patients with metal implants or seizure risk, uncontrolled severe psychiatric or cognitive disorders, severe medical comorbidities, substance abuse, or non‑peripheral causes of pain may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, AiTBS could provide faster or greater pain relief than conventional rTMS and shorten the overall treatment time for patients.

How similar studies have performed: Standard rTMS has shown benefit for neuropathic pain in prior studies, but repeated‑session AiTBS in this accelerated therapeutic format is novel and not well tested for neuropathic pain.

Eligibility criteria

Inclusion Criteria:

* IASP diagnosis of peripheral neuropathic pain;
* At least three months after the onset of pain;
* At least moderate pain intensity (≥ 3 assessed by VAS or NRS);
* 18 years or older;
* Stable medical treatment from 2 weeks before allocation to the end of the trial;
* Willing to receive TMS treatment and capable of fulfilling clinical assessments.

Exclusion Criteria:

* Contradictions to TMS treatment, such as metal implants or seizure;
* Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);
* Aphasia or cognitive disorders (Mini mental state examination ≤ 24);
* Severe clinical disorders caused by tumor or other conditions;
* Severe cardiopulmonary dysfunction or extreme weakness;
* History of substance abuse (alcohol, drugs).

Where this trial is running

Hangzhou

• The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Ying Liu

Conditions Neuropathic Pain, Nociceptive Pain; AiTBS, rTMS, Neuropathic pain