Analgesic Effects of rTMS in Peripheral Neuropathic Pain

NCT02010281 | Completed DMC

• 2 other identifiers: P120126AOM 120141
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuropathic Pain

Keywords

rTMS; peripheral neuropathic pain; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

  each visit for up to 25 weeks

Secondary Outcomes (11)

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

  each visit for up 25 weeks

• quality of life assessment

  each visit up to 25 weeks

• Proportion of responders to rTMS

  at the end of treatment (25 weeks)

• Predictors of the response

  Baseline

• Safety evaluation

  each follow up visit for up to 25 weeks

Study Arms (3)

rTMS of the motor cortex (Magventure)

EXPERIMENTAL

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

Device: rTMS of prefrontal or motor cortex

rTMS placebo (magventure)

PLACEBO COMPARATOR

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

Device: rTMS of prefrontal or motor cortex

rTMS prefrontal cortex (magventure)

EXPERIMENTAL

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

Device: rTMS of prefrontal or motor cortex

Interventions

rTMS of prefrontal or motor cortex DEVICE

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

rTMS of the motor cortex (Magventure); rTMS placebo (magventure); rTMS prefrontal cortex (magventure)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 who can be monitored during the study period (30 weeks)
• Patients insured by a health insurance plan or entitled.

You may not qualify if:

• 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,
• Lack of proper filling of self-assessment of pain from baseline and randomization (at least 4 weekly pain scores 7 days) notebooks
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pain evaluation and treatement center, CHU Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, 92106, France

Location

Related Publications (2)

• Attal N, Branders S, Pereira A, Bouhassira D. Prediction of the response to repetitive transcranial magnetic stimulation of the motor cortex in peripheral neuropathic pain and validation of a new algorithm. Pain. 2025 Jan 1;166(1):34-41. doi: 10.1097/j.pain.0000000000003297. Epub 2024 Jun 14.

  PMID: 38875120 DERIVED

• 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.

  PMID: 34196698 DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• NADINE ATTAL, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: December 12, 2013
• Study Start: March 1, 2014
• Primary Completion: August 11, 2018
• Study Completion: May 11, 2019
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

FR (1)