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Recruiting NCT07148388

Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

No phase Interventional Neuropathic Pain, Nociceptive Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Neuropathic Pain, Nociceptive Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Visual analogue scale [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
Secondary outcome measures (6)
  • short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
  • 7-item pain interference scale of the Brief Pain Inventory (BPI) [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
  • The Patient Global Impression of Change (PGIC) [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
  • The 17-item Hamilton Depression Rating Scale (HAMD-17) [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
  • The Beck Depression Inventory-II (BDI-II) [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention]
  • TMS-EEG [Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07148388 · 2024-0669

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗