NCT05168319

Effects and Mechanism of Prolonged Continuous Theta Burst Stimulation on Neuropathic Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Neuropathic pain (NP) is one type of refractory chronic pain condition,medical treatments for NP is limited because of its poorly response. A noninvasive brain-stimulation method called transcranial magnetic stimulation (TMS) has garnered interest as an alternative treatment for intractable NP potentially through inducing therapeutic brain plasticity.Indeed, high-frequency (≥ 5 Hz) Repetitive TMS (rTMS) over the primary motor cortex (M1) is suggested to be able to reduce neuropathic pain in randomized controlled studies.Overall, the clinical application of rTMS in chronic pain is still limited by the response rate,the investigation of rTMS protocols is important for improving rTMS analgesia. Theta burst stimulation (TBS) mimics the bursts of neuronal firing which results in robust long-term potentiation. Continuous TBS (cTBS) is designed to decrease excitability, whereby prolonged cTBS (pcTBS, i.e. multiple cTBS being delivered continuously) has recently been demonstrated to increase excitability. More importantly, pcTBS was found to have comparable or even better analgesic effects than standard 10 Hz rTMS. These findings together call for more studies to validate the analgesic efficacy of pcTBS. In this study, the investigators aim to assess and compare the efficacy of prolonged continuous theta burst stimulation (pcTBS) with 10HZ rTMS in NP patients.

Detailed description

The investigators designed a randomized, double-blind, sham-controlled study at 1 center. fifty NP patients were randomly assigned to 3 groups. A series of 5 daily pcTBS(1200 pulses/session) or 10-Hz rTMS (1500 pulses/session) of primary motor cortex (M1) or sham stimulation was applied to each patients.

Conditions

• Neuropathic Pain
• Repetitive Transcranial Magnetic Stimulation

Interventions

Type	Name	Description
DEVICE	Repetitive transcranial magnetic stimulation	Participants received 10HZ rTMS protocol consisted of 5 sessions over 5 consecutive workdays
DEVICE	Repetitive transcranial magnetic stimulation	Participants received pcTBS protocol consisted of 5 sessions over 5 consecutive workdays
DEVICE	Sham stimulation	Participants received Sham rTMS stimulations consisted of 5 sessions over 5 consecutive workdays

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-12-31
• Completion: 2023-01-30
• First posted: 2021-12-23
• Last updated: 2023-10-31

Locations

1 site across 1 country: China