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Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

RecruitingNAAges 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, …
NCT07148388 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The present study was designed to be the first to evaluate the efficacy of the AiTBS protocol to relieve neuropathic pain in a therapeutic setting, i.e. with repeated stimulation sessions. The investigator directly compared the analgesic efficacy of AiTBS versus conventional 10-Hz rTMS delivered to the left M1. In addition to pain experiences, The investigator examined the effects of intervention on corticospinal excitability that assessed by TMS-EEG. The working hypothesis was that AiTBS would result in larger analgesic and significant cortical excitability changes compared to 10-Hz rTMS. Eligible patients were randomly assigned to receive either 5 days of AiTBS within 10 days (6 sessions per day) or 10 consecutive days of classic 10Hz rTMS intervention. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.

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📋 Eligibility rules (as published)
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).
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What it tests

  • Repetitive transcranial magnetic stimulation
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Where

1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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