Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2025-09-12
Last updated
2026-01-26
Condition(s) studied
Neuropathic Pain, Nociceptive Pain
Investigational drug(s) / intervention(s)
Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation: Patients in the AiTBS group received 5 consecutive days of AiTBS treatment, with 6 sessions of iTBS interventions per day (1800 pulses per trial, with a 50-minute interval between trials). Patients in the 10Hz rTMS group received 10 consecutive days of 10Hz rTMS treatment within 10 days, with 1500 pulses per day, totaling 15 minutes.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Visual analogue scale — Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)".
The individual being evaluated marks a point on the line that corresponds to their current experience. The score is determined by measuring the distance from this mark to the "0" end, converted into a numerical value ranging from 0 to 10 (where each centimeter equals 1 point). Higher scores indicate a stronger intensity of the experience.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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