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Study of rTMS Analgesic Effect in Chronic Neuropathic Pain, (NEUROSTIM)

Primary Purpose

Chronic Neuropathic Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RepetitiveTranscranial Magnetic Stimulation (rTMS)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neuropathic Pain focused on measuring rTMS, Chronic neuropathic pain, Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient's written consent
  • Affiliated with social security system
  • Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain.
  • Patient whose analgesic treatment, is stable for at least 1 month.
  • Patient not responding to conventional treatments
  • Prescreening EVN >3

Exclusion Criteria:

  • History of drug addiction, epilepsy, cranial trauma
  • History of psychiatric disorder
  • Patients previously treated with rTMS
  • Patient with intracranial ferromagnetic material or implanted stimulator
  • New treatment for less than one month
  • Pregnant or Breastfeeding woman
  • Patient who does not understand the study protocol
  • Persons who are protected under the act.

Sites / Locations

  • Centre de la douleur, CHU Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Classic rTMS Stimulation using the B65 Coil

Deeper rTMS Stimulation using the B70 Coil

control group with a sham stimulation using a sham coil

Arm Description

Outcomes

Primary Outcome Measures

Evolution of Pain.
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).

Secondary Outcome Measures

Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS
Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Rate of Responding Patients.
Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS.
Assessment of Overall Patient Improvement.
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Quality of Life Improvement.
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Evolution of Anxiety and Depressive Traits.
Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.
Evolution of Symptomatological Profiles of Neuropathic Pain.
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Autonomous System Assessement.
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Evolution of the use of analgesic treatments.
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Analgesic Response Analysis
Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients
Improvement of pain triggered by a stimulus (allodynia).
Comparison between the 3 groups of allodynia improvement.

Full Information

First Posted
June 3, 2021
Last Updated
December 20, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT04936646
Brief Title
Study of rTMS Analgesic Effect in Chronic Neuropathic Pain,
Acronym
NEUROSTIM
Official Title
Randomized Double-blind Study of rTMS Analgesic Effect in Chronic Neuropathic Pain. Comparison Between Three Groups: Motor Cortex Stimulation by the Classic Coil B65, Deeper Stimulation by the Coil B70 and Placebo Stimulation. Analysis of Long-term rTMS-induced Brain Changes Using fMRI.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the analgesic effectiveness of three modes of repetitive Transcranial Magnetic Stimulation (rTMS) in chronic neuropathic pain: Classical rTMS stimulation Deeper rTMS stimulation Sham rTMS stimulation
Detailed Description
Conduct of study: Entry into the study: After informed consent, patients will be randomised. The physician responsible for conducting neurostimulation sessions will make the randomization via an interactive web response system (IWRS). Only this physician will have the knowledge of the group allocated to the patient. Baseline : Patients, will record on a diary form, a daily Visual Numeric Scale(VNS) of Pain Intensity for 1 week. Treatment sessions: after the baseline, sessions of neurostimulation will begin for seven weeks. After the end of neurostimulation sessions, patients will be followed for 2 weeks. Throughout their participation in the study, patients will plot on a diary form their daily VNS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain
Keywords
rTMS, Chronic neuropathic pain, Repetitive Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classic rTMS Stimulation using the B65 Coil
Arm Type
Experimental
Arm Title
Deeper rTMS Stimulation using the B70 Coil
Arm Type
Experimental
Arm Title
control group with a sham stimulation using a sham coil
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
RepetitiveTranscranial Magnetic Stimulation (rTMS)
Intervention Description
The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.
Primary Outcome Measure Information:
Title
Evolution of Pain.
Description
Comparison between the 3 groups of the evolution of the weekly value of the Visual Numeric Scale (VNS): The patient will raise his pain level on a follow-up diary each day. The VNS average will be calculated for each week. The NSV is a 10-point scale, ranging from 0 (worse) to 10 (better).
Time Frame
Pain progression will be assessed from week 1 (before treatment) to week 7 (end of treatment)
Secondary Outcome Measure Information:
Title
Assesment of Potential Changes in Sensory-motor Cortical Maps Induced by rTMS
Description
Comparison between the 3 groups of changes in sensory-motor cortical maps using Functional magnetic resonance imaging (FMRI).
Time Frame
Day 60 from the beginning of rTMS treatment compared to baseline.
Title
Rate of Responding Patients.
Description
Comparison between the 3 groups of the rate of responding patients. Responding patients is defined by a 30% reduction in pain intensity assessed with VNS.
Time Frame
week 7 compared with baseline
Title
Assessment of Overall Patient Improvement.
Description
Comparison between the 3 groups of the overall patient improvement using the Clinical Global Impression of Change scale (CGI).The CGI is a 7-point scale, ranging from 1 (better) to 7 (worse).
Time Frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Title
Quality of Life Improvement.
Description
Comparison between the 3 groups of the improvement of quality of life using the SF12 (Short Form 12) questionnaire.SF12 includes a mental and social score ranging from 5.89 to 71.97 and a physical score ranging from 9.95 to 70. a high score indicates a better quality of life.
Time Frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Title
Evolution of Anxiety and Depressive Traits.
Description
Comparison between the 3 groups of the improvement of anxiety and depressive traits using the HADS questionnaire (Hospital Anxiety and Depression Scale).the HADS score varies between 0 and 42. zero corresponding to the best score.
Time Frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline
Title
Evolution of Symptomatological Profiles of Neuropathic Pain.
Description
Comparison between the 3 groups of symptomatological profiles of neuropathic pain using NPSI questionnaire (Neuropathic Pain Symptom Inventory).
Time Frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.
Title
Sympathetic Autonomic System Injury and Small Fiber Neuropathy.
Description
Comparison between the 3 groups of sympathetic autonomic system injury and small fiber neuropathy using the Sudoscan® device.
Time Frame
Day 60 from the beginning of rTMS treatment compared to baseline.
Title
Autonomous System Assessement.
Description
Comparison between the 3 groups of changes in skin tension and conductance during fMRI examination.
Time Frame
Day 60 from the beginning of rTMS treatment compared to baseline.
Title
Evolution of the use of analgesic treatments.
Description
Comparison between the 3 groups of the evolution of the use of analgesic treatments reported on the diary.
Time Frame
From baseline to day 60.
Title
Analgesic Response Analysis
Description
Comparison between the 3 groups of the evolution of the weekly EVN average according to the clinical profile of patients
Time Frame
From baseline to day 60.
Title
Improvement of pain triggered by a stimulus (allodynia).
Description
Comparison between the 3 groups of allodynia improvement.
Time Frame
Day 30 and day 60 from the beginning of rTMS treatment compared to baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient's written consent Affiliated with social security system Male or female, suffering for more than a year from unilateral refractory neuropathic pain: hemi-body, upper limb, lower limb and facial chronic pain. Patient whose analgesic treatment, is stable for at least 1 month. Patient not responding to conventional treatments Prescreening EVN >3 Exclusion Criteria: History of drug addiction, epilepsy, cranial trauma History of psychiatric disorder Patients previously treated with rTMS Patient with intracranial ferromagnetic material or implanted stimulator New treatment for less than one month Pregnant or Breastfeeding woman Patient who does not understand the study protocol Persons who are protected under the act.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan HODAJ, MD
Phone
04-76-76-52-13
Ext
33
Email
HHodaj@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan HODAJ, MD
Organizational Affiliation
CHUGA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de la douleur, CHU Grenoble Alpes
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HODAj Hasan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of rTMS Analgesic Effect in Chronic Neuropathic Pain,

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