Back to resultsOptimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain
Primary Purpose
Neuropathic Pain, Repetitive Transcranial Magnetic Stimulation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Repetitive transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Neuropathic Pain
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;
Sites / Locations
- The second affliated hospital of zhejiang university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
pcTBS
10HZ rTMS
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Motor-evoked potential (MEP)
Corticospinal excitability was measured with MEP at rest of the first dorsal interosseous (FDI) muscle, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward).
Cortical silent period (CSP)
Corticospinal excitability was measured with CSP during a sustained voluntary FDI muscle contraction, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward).
The sensory dimension of pain
The sensory dimension of pain (rated on 33) measured with Short form of the McGill Pain questionnaire (SF-MPQ) .
The affective dimension of pain
The affective dimension of pain measured with Short form of the McGill Pain questionnaire (SF-MPQ) .
Pain interference scale
7 items rated from 0= does not interfere to 10= complete interference, total score 70 from the Brief Pain Inventory.
Patients global impression of change
the 7 items Patients global impression of change (PGIC) (from very much worse to very much improved)
The depression score
ranging from 0 to 13 with higher scores indicating more severe depression from the 13 items Beck Depression Inventory (BDI)
Full Information
NCT ID
NCT05338554
First Posted
December 16, 2021
Last Updated
February 14, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05338554
Brief Title
Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain
Official Title
Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Repetitive Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients and assessors were blind to group assignment until the study was completed.
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pcTBS
Arm Type
Experimental
Arm Description
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.
Arm Title
10HZ rTMS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
pain intensity measured with the visuo-analogic scale (VAS)
Description
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.
Time Frame
through study completion, an average of 8 months
Secondary Outcome Measure Information:
Title
Motor-evoked potential (MEP)
Description
Corticospinal excitability was measured with MEP at rest of the first dorsal interosseous (FDI) muscle, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward).
Time Frame
through study completion, an average of 8 months
Title
Cortical silent period (CSP)
Description
Corticospinal excitability was measured with CSP during a sustained voluntary FDI muscle contraction, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward).
Time Frame
through study completion, an average of 8 months
Title
The sensory dimension of pain
Description
The sensory dimension of pain (rated on 33) measured with Short form of the McGill Pain questionnaire (SF-MPQ) .
Time Frame
through study completion, an average of 8 months
Title
The affective dimension of pain
Description
The affective dimension of pain measured with Short form of the McGill Pain questionnaire (SF-MPQ) .
Time Frame
through study completion, an average of 8 months
Title
Pain interference scale
Description
7 items rated from 0= does not interfere to 10= complete interference, total score 70 from the Brief Pain Inventory.
Time Frame
through study completion, an average of 8 months
Title
Patients global impression of change
Description
the 7 items Patients global impression of change (PGIC) (from very much worse to very much improved)
Time Frame
through study completion, an average of 8 months
Title
The depression score
Description
ranging from 0 to 13 with higher scores indicating more severe depression from the 13 items Beck Depression Inventory (BDI)
Time Frame
through study completion, an average of 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min yan, prof
Organizational Affiliation
The second affiliated hospital of Zhejiang University hangzhou
Official's Role
Study Chair
Facility Information:
Facility Name
The second affliated hospital of zhejiang university
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
investigators do not plan to make individual participant data (IPD) available to other researchers.
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Optimize the Effects of Repetitive Transcranial Magnetic Stimulation on Neuropathic Pain
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