Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain

NCT05338554 | Completed DMC

• 1 other identifier: 2021-0752
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• pain intensity measured with the visuo-analogic scale (VAS)

  For non-responders:the primary outcome measure is the mean change from baseline over the course of 5 (group by time interaction) in average pain intensity measured with the visuo-analogic scale (VAS) ( 0= no pain and 10= maximal pain). Pain intensity is further assessed immediately before each rTMS session at days 2, 3, 4, 5, and then at weeks 2, 3, 4 after the intervention. For responders: pain intensity is assessed after two sessions of rTMS session and then at weeks 2, 3, 4 after the intervention.

  through study completion, an average of 8 months

Secondary Outcomes (7)

• Motor-evoked potential (MEP)

  through study completion, an average of 8 months

• Cortical silent period (CSP)

  through study completion, an average of 8 months

• The sensory dimension of pain

  through study completion, an average of 8 months

• The affective dimension of pain

  through study completion, an average of 8 months

• Pain interference scale

  through study completion, an average of 8 months

Study Arms (2)

pcTBS

EXPERIMENTAL

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.

Device: Repetitive transcranial magnetic stimulation

10HZ rTMS

EXPERIMENTAL

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)

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation 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).

pcTBS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• (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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affliated hospital of zhejiang university

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• min yan, prof

  The second affiliated hospital of Zhejiang University hangzhou

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and assessors were blind to group assignment until the study was completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After 5 consecutive days of 10HZ rTMS or pcTBS intervention of previous study, patients were divided into responders and non-responders according to the change of pain intensity measured with VAS and both of them will receive different trial of interventions.

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: April 21, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)