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Neuropathic PainTRANSNEPNCT02010281

Analgesic Effects of rTMS in Peripheral Neuropathic Pain

A study testing rTMS of prefrontal or motor cortex in people with Neuropathic Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuropathic Pain
What is being tested?
rTMS of prefrontal or motor cortex
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteFrance
Study dates
Mar 2014to 11 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pain evaluation and treatement center, CHU Ambroise Paré

    Boulogne-Billancourt, Hauts-de-Seine, 92106

Other trials in France

About this study

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

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).

Read the 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.

Being tested
rTMS of prefrontal or motor cortex
Keywords
rTMS, peripheral neuropathic pain, randomized controlled trial
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rTMS of prefrontal or motor cortexDevice

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

Study groups in NCT02010281
Study groupRoleWhat they receive
rTMS of the motor cortex (Magventure)Experimentalexperimental : rTMS of the motor cortex : repetitive magnetic stimulation targeting the motor cortex assisted by neuronavigation
Receives: Device: rTMS of prefrontal or motor cortex
rTMS placebo (magventure)Placebo comparatorsham stimulation of the motor or prefrontal cortex with the placebo face of the device
Receives: Device: rTMS of prefrontal or motor cortex
rTMS prefrontal cortex (magventure)ExperimentalExperimental : repetitive transcranial stimulation targeting the prefrontal cortex as indicated by neuronavigation
Receives: Device: rTMS of prefrontal or motor cortex

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: each visit for up to 25 weeks

Secondary outcomes (11)

  1. 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

    Measured: each visit for up 25 weeks

  2. quality of life assessment

    quality of life on the Eurogol questionnaire

    Measured: each visit up to 25 weeks

  3. 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

    Measured: at the end of treatment (25 weeks)

  4. 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)

    Measured: Baseline

  5. Safety evaluation

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

    Measured: each follow up visit for up to 25 weeks

  6. Onset of the analgesic effect of rTMS

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

    Measured: one mont afer the beginning of rTMS

  7. Return to work

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

    Measured: 25 weeks

  8. Maximal pain

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

    Measured: each visit up to 25 weeks

  9. Pain right now

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

    Measured: each visit up to 25 weeks

  10. Sleep

    sleep quality and quantity on MOS sleep

    Measured: each visit up to 25 weeks

  11. Neuropathic symptoms

    Neuropathic symptoms on the Neuropathic Pain Symptom Inventory

    Measured: each visit up to 25 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2013 (estimated)
  2. Study startMar 2014
  3. Primary completion11 Aug 2018
  4. Study completion11 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02010281
Sponsor's protocol ID
P120126
Other IDs
AOM 120141
Acronym
TRANSNEP
Status last verified
Jun 2019
First submitted
7 Nov 2013
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38875120

  • 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.

    PubMed 34196698

Questions about this trial

What is this clinical trial studying?

A study testing rTMS of prefrontal or motor cortex in people with Neuropathic Pain, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average pain intensity from baseline to week 25 (time frame: each visit for up to 25 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02010281, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.

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