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Analgesic Effects of rTMS in Peripheral Neuropathic Pain (TRANSNEP)

Primary Purpose

Neuropathic Pain

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

rTMS of prefrontal or motor cortex

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring rTMS, peripheral neuropathic pain, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Peripheral neuropathic pain (unilateral or bilateral) probable or defined according to the criteria proposed in 2008 (Treede et al 2008),
Diagnostic DN4 questionnaire score greater than or equal to 4/10 (Bouhassira et al 2005),
chronic pain, the average intensity is greater than or equal to 40/100
Daily or almost daily pain (at least 4 days out of 7)
This pain is present for more than 6 months
Patients over 18 and under 75 years old
Patients who signed informed consent,
Patients whose pain medication is stable for 15 days before inclusion, and will not need to be changed during the study period,
Patients who can be monitored during the study period (30 weeks)
Patients insured by a health insurance plan or entitled.

Exclusion Criteria:

Previous treatment using rTMS,
Work Accident or dispute
rTMS Cons-indications (ECT treatment during the previous month, epilepsy and / or a history of epilepsy; history of head trauma, neurosurgical lesion, intracranial hypertension, metal clip, pacemaker, pregnant or lactating women)
Abuse of drugs or psychoactive substances (DSM IV)
Central neuropathic pain,
Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
Neuropathic pain very limited extent, of neuroma type
Current major depression or psychosis according to DSM IV criteria,
Intermittent pain,
Pain for less than six months,
Presence of another pain more severe than the one justifying the inclusion
Lack of proper filling of self-assessment of pain from baseline and randomization (at least 4 weekly pain scores 7 days) notebooks
Lack of stability of pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain on the short questionnaire about pain between the first two visits inclusion
Subject unable to understand informed consent, under guardianship,
Subject who refuses to stop or can not stop prohibited treatment during the study,
Patients participating in another research protocol involving a drug within 30 days before enrollment.

Sites / Locations

Pain evaluation and treatement center, CHU Ambroise Paré

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

rTMS of the motor cortex (Magventure)

rTMS placebo (magventure)

rTMS prefrontal cortex (magventure)

Arm Description

experimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation

sham stimulation of the motor or prefrontal cortex with the placebo face of the device

Experimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation

Outcomes

Primary Outcome Measures

Change in average pain intensity from baseline to week 25

Change in average pain intensity from baseline to week 25, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory

Secondary Outcome Measures

change in minimal pain intensity over the last 24 hours from baseline to week 25

change in minimal pain over the last 24 hours on the Brief Pain inventory

quality of life assessment

quality of life on the Eurogol questionnaire

Proportion of responders to rTMS

Proportion of responders (patients whose pain is improved by at least 30% and 50% compared to their pain before treatment

Predictors of the response

Evaluation of predictors of response (nature of neuropathic symptoms, severity of anxiety or depressive symptoms, presence or absence of mechanical allodynia, or dramatization importance of catastrophism related to pain)

Safety evaluation

Collection of side effects at each session and between sessions of rTMS

Onset of the analgesic effect of rTMS

Determine the onset of the analgesic effect based on patient pain diaries for up to 1 month

Return to work

Return to work on a specific questionnaire at the end of the study

Maximal pain

Maximal pain over the past 24 hours on the Brief Pain Inventory

Pain right now

Pain right now immediately after each rtMS session and between sessions for up to 25 weeks

Sleep

sleep quality and quantity on MOS sleep

Neuropathic symptoms

Neuropathic symptoms on the Neuropathic Pain Symptom Inventory

Full Information

NCT ID

NCT02010281

First Posted

November 7, 2013

Last Updated

June 18, 2019

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02010281

Brief Title

Analgesic Effects of rTMS in Peripheral Neuropathic Pain

Acronym

TRANSNEP

Official Title

Long-term Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) of the Motor or Prefrontal Cortex in Peripheral Neuropathic Pain: a Multicenter Randomized Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

August 11, 2018 (Actual)

Study Completion Date

May 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity, quality of life, sleep, neuropathic symptoms, return to work, in patients with peripheral neuropathic pain. The medical device of study: transcranial magnetic stimulator (TMS).

Detailed Description

The present multicenter parallel session randomized placebo controlled study (4 French centers) aims to evaluate the long term efficacy over 25 weeks of repeated sessions of magnetic transcranial stimulation of the motor cortex or prefrontal cortex on average pain intensity (primary outcome) and several secondary outcome measures (e.g. quality of life, sleep, neuropathic symptoms, return to work), in patients with peripheral neuropathic pain. The patients will be randomized to receive one of 3 treatment arms : rTMS of the motor cortex, rTMS of the prefrontal cortex, or placebo (sham stimulation) of the motor or prefrontal cortex. The study will be double blind, eg the patient and the investigator will not know the nature of treatment. the stimulation protocol will consist of an induction phasse of 5 daily sessions then a maintenance phase of several sessions : 3 sessions a week apart, 3 sessions a fortnight apart, and 3 sessions 3 weeks apart. The statistical analysis will be conducted in the intent to treat population and using a modified ITT analysis excluding all the patients with protocol violation (primary outcome). The per protocol population will also be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain

Keywords

rTMS, peripheral neuropathic pain, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rTMS of the motor cortex (Magventure)

Arm Type

Experimental

Arm Description

experimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation

Arm Title

rTMS placebo (magventure)

Arm Type

Placebo Comparator

Arm Description

sham stimulation of the motor or prefrontal cortex with the placebo face of the device

Arm Title

rTMS prefrontal cortex (magventure)

Arm Type

Experimental

Arm Description

Experimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation

Intervention Type

Device

Intervention Name(s)

rTMS of prefrontal or motor cortex

Intervention Description

description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation

Primary Outcome Measure Information:

Title

Change in average pain intensity from baseline to week 25

Description

Change in average pain intensity from baseline to week 25, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory

Time Frame

each visit for up to 25 weeks

Secondary Outcome Measure Information:

Title

change in minimal pain intensity over the last 24 hours from baseline to week 25

Description

change in minimal pain over the last 24 hours on the Brief Pain inventory

Time Frame

each visit for up 25 weeks

Title

quality of life assessment

Description

quality of life on the Eurogol questionnaire

Time Frame

each visit up to 25 weeks

Title

Proportion of responders to rTMS

Description

Proportion of responders (patients whose pain is improved by at least 30% and 50% compared to their pain before treatment

Time Frame

at the end of treatment (25 weeks)

Title

Predictors of the response

Description

Time Frame

Baseline

Title

Safety evaluation

Description

Collection of side effects at each session and between sessions of rTMS

Time Frame

each follow up visit for up to 25 weeks

Title

Onset of the analgesic effect of rTMS

Description

Determine the onset of the analgesic effect based on patient pain diaries for up to 1 month

Time Frame

one mont afer the beginning of rTMS

Title

Return to work

Description

Return to work on a specific questionnaire at the end of the study

Time Frame

25 weeks

Title

Maximal pain

Description

Maximal pain over the past 24 hours on the Brief Pain Inventory

Time Frame

each visit up to 25 weeks

Title

Pain right now

Description

Pain right now immediately after each rtMS session and between sessions for up to 25 weeks

Time Frame

each visit up to 25 weeks

Title

Sleep

Description

sleep quality and quantity on MOS sleep

Time Frame

each visit up to 25 weeks

Title

Neuropathic symptoms

Description

Neuropathic symptoms on the Neuropathic Pain Symptom Inventory

Time Frame

each visit up to 25 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Peripheral neuropathic pain (unilateral or bilateral) probable or defined according to the criteria proposed in 2008 (Treede et al 2008), Diagnostic DN4 questionnaire score greater than or equal to 4/10 (Bouhassira et al 2005), chronic pain, the average intensity is greater than or equal to 40/100 Daily or almost daily pain (at least 4 days out of 7) This pain is present for more than 6 months Patients over 18 and under 75 years old Patients who signed informed consent, Patients whose pain medication is stable for 15 days before inclusion, and will not need to be changed during the study period, Patients who can be monitored during the study period (30 weeks) Patients insured by a health insurance plan or entitled. Exclusion Criteria: Previous treatment using rTMS, Work Accident or dispute rTMS Cons-indications (ECT treatment during the previous month, epilepsy and / or a history of epilepsy; history of head trauma, neurosurgical lesion, intracranial hypertension, metal clip, pacemaker, pregnant or lactating women) Abuse of drugs or psychoactive substances (DSM IV) Central neuropathic pain, Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease) Neuropathic pain very limited extent, of neuroma type Current major depression or psychosis according to DSM IV criteria, Intermittent pain, Pain for less than six months, Presence of another pain more severe than the one justifying the inclusion Lack of proper filling of self-assessment of pain from baseline and randomization (at least 4 weekly pain scores 7 days) notebooks Lack of stability of pain scores on two successive evaluations, defined as a change of more than 30% between the two assessments of the average pain on the short questionnaire about pain between the first two visits inclusion Subject unable to understand informed consent, under guardianship, Subject who refuses to stop or can not stop prohibited treatment during the study, Patients participating in another research protocol involving a drug within 30 days before enrollment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

NADINE ATTAL, MD, PhD

Organizational Affiliation

Pain evaluation and treatment center, CHU A Paré, 92104 Boulogne Billancourt, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pain evaluation and treatement center, CHU Ambroise Paré

City

Boulogne Billancourt

State/Province

Hauts-de-Seine

ZIP/Postal Code

92106

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

34196698

Citation

Attal N, Poindessous-Jazat F, De Chauvigny E, Quesada C, Mhalla A, Ayache SS, Fermanian C, Nizard J, Peyron R, Lefaucheur JP, Bouhassira D. Repetitive transcranial magnetic stimulation for neuropathic pain: a randomized multicentre sham-controlled trial. Brain. 2021 Dec 16;144(11):3328-3339. doi: 10.1093/brain/awab208.

Results Reference

derived

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Analgesic Effects of rTMS in Peripheral Neuropathic Pain

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