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Analgesic Effects of rTMS in Peripheral Neuropathic Pain (TRANSNEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02010281
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).


Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: rTMS of prefrontal or motor cortex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2014
Actual Primary Completion Date : August 11, 2018
Actual Study Completion Date : May 11, 2019

Arm Intervention/treatment
Experimental: rTMS of the motor cortex (Magventure)
experimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation
Device: rTMS of prefrontal or motor cortex
description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation

Placebo Comparator: rTMS placebo (magventure)
sham stimulation of the motor or prefrontal cortex with the placebo face of the device
Device: rTMS of prefrontal or motor cortex
description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation

Experimental: rTMS prefrontal cortex (magventure)
Experimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation
Device: rTMS of prefrontal or motor cortex
description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation




Primary Outcome Measures :
  1. Change in average pain intensity from baseline to week 25 [ Time Frame: each visit for up to 25 weeks ]
    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 :
  1. change in minimal pain intensity over the last 24 hours from baseline to week 25 [ Time Frame: each visit for up 25 weeks ]
    change in minimal pain over the last 24 hours on the Brief Pain inventory

  2. quality of life assessment [ Time Frame: each visit up to 25 weeks ]
    quality of life on the Eurogol questionnaire

  3. Proportion of responders to rTMS [ Time Frame: at the end of treatment (25 weeks) ]
    Proportion of responders (patients whose pain is improved by at least 30% and 50% compared to their pain before treatment

  4. Predictors of the response [ Time Frame: Baseline ]
    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)

  5. Safety evaluation [ Time Frame: each follow up visit for up to 25 weeks ]
    Collection of side effects at each session and between sessions of rTMS

  6. Onset of the analgesic effect of rTMS [ Time Frame: one mont afer the beginning of rTMS ]
    Determine the onset of the analgesic effect based on patient pain diaries for up to 1 month

  7. Return to work [ Time Frame: 25 weeks ]
    Return to work on a specific questionnaire at the end of the study

  8. Maximal pain [ Time Frame: each visit up to 25 weeks ]
    Maximal pain over the past 24 hours on the Brief Pain Inventory

  9. Pain right now [ Time Frame: each visit up to 25 weeks ]
    Pain right now immediately after each rtMS session and between sessions for up to 25 weeks

  10. Sleep [ Time Frame: each visit up to 25 weeks ]
    sleep quality and quantity on MOS sleep

  11. Neuropathic symptoms [ Time Frame: each visit up to 25 weeks ]
    Neuropathic symptoms on the Neuropathic Pain Symptom Inventory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Previous treatment using rTMS,
  2. Work Accident or dispute
  3. 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)
  4. Abuse of drugs or psychoactive substances (DSM IV)
  5. Central neuropathic pain,
  6. Neuropathic pain within the framework of a progressive disease (HIV, cancer, non-stabilized system disease)
  7. Neuropathic pain very limited extent, of neuroma type
  8. Current major depression or psychosis according to DSM IV criteria,
  9. Intermittent pain,
  10. Pain for less than six months,
  11. Presence of another pain more severe than the one justifying the inclusion
  12. Lack of proper filling of self-assessment of pain from baseline and randomization (at least 4 weekly pain scores 7 days) notebooks
  13. 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
  14. Subject unable to understand informed consent, under guardianship,
  15. Subject who refuses to stop or can not stop prohibited treatment during the study,
  16. Patients participating in another research protocol involving a drug within 30 days before enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010281


Locations
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France
Pain evaluation and treatement center, CHU Ambroise Paré
Boulogne Billancourt, Hauts-de-Seine, France, 92106
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: NADINE ATTAL, MD, PhD Pain evaluation and treatment center, CHU A Paré, 92104 Boulogne Billancourt, France
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02010281    
Other Study ID Numbers: P120126
AOM 120141 ( Other Identifier: APHP )
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Keywords provided by Assistance Publique - Hôpitaux de Paris:
rTMS
peripheral neuropathic pain
randomized controlled trial
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms