Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain

NCT ID: NCT05338554

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-12-31

Brief Summary

Neuropathic pain (NP) is one type of refractory chronic pain condition,medical treatments for NP is limited because of its poorly response.Repetitive transcranial magnetic stimulation (rTMS) can induce neuroplastic changes which has been used to manage chronic pain conditions. Indeed, high-frequency (≥ 5 Hz) 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, whereby it is close to moderate and far from being excellent at its best. Therefore this project designed a series of clinical trials to optimize the analgesic efficacy of rTMS. According to the research results of investigators previous project, patients with neuropathic pain were divided into responders and non-responders after 5 consecutive days of 10HZ rTMS or pcTBS intervention (see project ID:2021-0751)according to the change of pain intensity, and then different trials will be applied to responders and non-responders to optimize the analgesic effect of rTMS.

Detailed Description

For non-responders (whose visuo-analogic scale (VAS) decreased less than 20 mm or T1-T0/T0×100%<30%), a feasible method is to switch stimulation targets. So the investigator will change the stimulation target from M1 to dorsolateral prefrontal cortex (DLPFC), and then delivered another 5 days consecutive interventions to assess the efficacy.

For responders (whose VAS decreased an average of 20 mm or more or T1-T0/T0×100%≥30%), the investigator further investigate the long-lasting effect of rTMS. the patients will participate a continuous trials (2 sessions weekly for 2 weeks) and 4 weeks follow up.

Conditions

Neuropathic Pain; Repetitive Transcranial Magnetic Stimulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

pcTBS

The protocol is same as the previous study: pcTBS was administered to the left M1 at 80% resting motor threshold (RMT), consisting of a burst of 3 pulses given at 50 Hz repeated every 5 Hz using repetitive transcranial magnetic stimulation device . A total of 1,200 pulses were delivered with the TMS coil positioned in a posterior-anterior (PA) direction parallel to the midline.

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Magnetic stimulation was performed using a figure-eight coil connected to a Magstim Rapid2 system, All patients seat in a comfortable reclining chair and delivered pcTBS protocol using repetitive transcranial magnetic stimulation . The stimulation intensity was set to 80% of the resting motor threshold, which is measured as the minimal intensity of stimulation evoking an electromyographic response ≥50µV on the first dorsal interosseus muscle of the hand contralateral to the stimulated hemisphere in at least 5 out of 10 trials. For this measurement, a figure-of-eight coil is positioned over the hand motor hotspot and oriented perpendicular to the central sulcus (parallel to the hemispheric midline).

10HZ rTMS

The protocol is same as the previous study: 10HZ rTMS included 15 trains of 10-second stimulation given at 10 Hz to the left M1 at 80% resting motor threshold (RMT) using repetitive transcranial magnetic stimulation device , with the inter-train interval being set to 50 seconds (1500 pulses)

Group Type: EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Magnetic stimulation was performed using a figure-eight coil connected to a Magstim Rapid2 system, All patients seat in a comfortable reclining chair and delivered 10HZ protocol using repetitive transcranial magnetic stimulation . The stimulation intensity was set to 80% of the resting motor threshold, which is measured as the minimal intensity of stimulation evoking an electromyographic response ≥50µV on the first dorsal interosseus muscle of the hand contralateral to the stimulated hemisphere in at least 5 out of 10 trials. For this measurement, a figure-of-eight coil is positioned over the hand motor hotspot and oriented perpendicular to the central sulcus (45° away from the hemispheric midline).

Interventions

Repetitive transcranial magnetic stimulation

Magnetic stimulation was performed using a figure-eight coil connected to a Magstim Rapid2 system, All patients seat in a comfortable reclining chair and delivered pcTBS protocol using repetitive transcranial magnetic stimulation . The stimulation intensity was set to 80% of the resting motor threshold, which is measured as the minimal intensity of stimulation evoking an electromyographic response ≥50µV on the first dorsal interosseus muscle of the hand contralateral to the stimulated hemisphere in at least 5 out of 10 trials. For this measurement, a figure-of-eight coil is positioned over the hand motor hotspot and oriented perpendicular to the central sulcus (parallel to the hemispheric midline).

Intervention Type: DEVICE

Repetitive transcranial magnetic stimulation

Magnetic stimulation was performed using a figure-eight coil connected to a Magstim Rapid2 system, All patients seat in a comfortable reclining chair and delivered 10HZ protocol using repetitive transcranial magnetic stimulation . The stimulation intensity was set to 80% of the resting motor threshold, which is measured as the minimal intensity of stimulation evoking an electromyographic response ≥50µV on the first dorsal interosseus muscle of the hand contralateral to the stimulated hemisphere in at least 5 out of 10 trials. For this measurement, a figure-of-eight coil is positioned over the hand motor hotspot and oriented perpendicular to the central sulcus (45° away from the hemispheric midline).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• （1）woman or man over 18 years and under 85 years; （2）Clinical diagnosis of neuropathic pain (3) pain for at least 3 months, at least moderate intensity (≥ 4/10 assessed by VAS) ; (4) stable pharmacological treatment for pain at least 2 weeks before inclusion; (5) able to cooperate in completing questionnaire.

Exclusion Criteria

• (1)Any clinically significant or unstable ongoing medical or psychiatric disorder including major depression; (2) History of substance abuse (alcohol, drugs); (3) Past treatment with repetitive transcranial magnetic stimulation (rTMS); (4) Contraindications to rTMS (previous severe head trauma or neurosurgical intervention, past or current epilepsy, active brain tumor, intracranial hypertension, implanted ferromagnetic devices, e.g., cardiac pacemaker, neurostimulator, or cochlear implants); (5) other type of pain more severe than neuropathic pain; (6) Any difficulty to fill out questionnaires (due to language or cognitive problems); (7) impossibility to be followed during the time course of the study;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

min yan, prof

Role: STUDY_CHAIR

The second affiliated hospital of Zhejiang University hangzhou

Locations

The second affliated hospital of zhejiang university

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2021-0752

Identifier Type: -

Identifier Source: org_study_id