Accelerated intermittent theta burst stimulation for neuropathic pain
Official title: Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07148388 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | September 12, 2025 |
| Main results expected | September 1, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT07148388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China Recruiting
Study contacts
- Study coordinator: Ying Liu
- Email: 350373328@qq.com
- Phone: 86-15595512306
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.