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

NCT05168319 | Completed DMC

• 1 other identifier: 2021-0751
• Study Type: interventional
• Target: 94
• 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. 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.

Conditions

Neuropathic Pain; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• The mean change from baseline in pain intensity measured with the visual-analogic scale (VAS)

  The primary outcome measure was the mean change from baseline over the course of 5 (group by time interaction) in average pain intensity measured with the visual-analogic scale (VAS) ( 0= no pain and 10= maximal pain). Baseline average pain intensity was assessed at inclusion then on the day of randomization, just before the first rTMS session (day 1) and corresponded to the average of these two values.

  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 and affective dimension of pain

  through study completion, an average of 8 months

• Pain interference scale

  through study completion, an average of 8 months

• Patients global impression of change

  through study completion, an average of 8 months

Study Arms (3)

pcTBS

EXPERIMENTAL

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. 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

ACTIVE COMPARATOR

The rTMS protocol included 15 trains of 10-second stimulation given at 10 Hz to the left M1 at 80% resting motor threshold (RMT), with the inter-train interval being set to 50 seconds (1500 pulses)

Device: Repetitive transcranial magnetic stimulation

Sham

SHAM COMPARATOR

The Sham stimulation was delivered using the same protocol, with the coil being orientated at 90° to the scalp so that the magnetic field would be delivered away from the scal

Device: Sham stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Participants received 10HZ rTMS protocol consisted of 5 sessions over 5 consecutive workdays

10HZ rTMS

Sham stimulation DEVICE

Participants received Sham rTMS stimulations consisted of 5 sessions over 5 consecutive workdays

Sham

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 affiliated hospital of Zhejiang University hangzhou

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and assessors were blind to group assignment until the study was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: fifty NP patients were randomly assigned to 3 groups.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 23, 2021
• Study Start: February 28, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2022-01

Locations

CN (1)