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NCT05360030

Mechanism of Analgesic Effect on Prolonged Continuous Theta Burst Stimulation

Completed NA Last updated 16 February 2023
What this trial tests

NA trial testing Naloxone in Chronic Pain in 45 participants. Completed in 31 December 2022.

Timeline
14 May 2022
Primary endpoint
1 December 2022
31 December 2022

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposediagnostic
Enrollment45
Start date14 May 2022
Primary completion1 December 2022
Estimated completion31 December 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 85, any sex, with Chronic Pain or rTMS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It has been shown that prolonged continuous theta burst stimulation (pcTBS) , a relatively new repetitive transcranial magnetic simulation (rTMS) protocol, of the primary motor cortex (M1) or dorsolateral prefrontal cortex (DLPFC) decreases pain in healthy volunteers, in various experimental models. In addition, rTMS of M1 has also been shown to have analgesic effects in various chronic pain conditions, including neuropathic pain.The mechanisms underlying rTMS-induced analgesia remain unclear. Functional neuroimaging studies have shown that rTMS of M1 and DLPFC induces changes in the activity of cortical and subcortical structures involved in pain processing and modulation. Endogenous opioids and e N-methyl-D-aspartate (NMDA) receptor are known to play a major role in these processes. The investigator hypothesized that the endogenous opioids systems (EOS) and NMDA receptor might be involved in the analgesic action of pcTBS. In the first part,the investigator compares the analgesic effects of motor cortex (M1) or dorsolateral prefrontal cortex (DLPFC) stimulation before and after naloxone or placebo treatment, the intensity of pain induced by capsaicin were used to evaluate the analgesic effects of pcTBS. If naloxone does not reverse the analgesic effect of pcTBS,The volunteers will be invited to participant the second part of the study, which the investigator compares the analgesic effects of motor cortex (M1) or dorsolateral prefrontal cortex (DLPFC) stimulation before and after Ketamine treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Characterizing the opioidergic mechanisms of repetitive transcranial magnetic stimulation-induced analgesia: a randomized controlled trial.
    Liu Y, Sun J, Wu C, Ren J, et al · · 2024 · cited 9× · PMID 38537053 · DOI 10.1097/j.pain.0000000000003220

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Other trials of Naloxone

Trials testing the same drug.

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

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Data sources for this page

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