Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia (H-FINEP)

March 25, 2026 updated by: Nadine ATTAL

Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study

This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Inserm U987
        • Principal Investigator:
          • Serge PERROT
        • Contact:
        • Sub-Investigator:
          • Didier BOUHASSIRA
      • Paris, France, 75014
        • Not yet recruiting
        • Centre d'Evaluation et de Traitement de la douleur
        • Contact:
        • Sub-Investigator:
          • Anne-Priscille TROUVIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearly every day
  • Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions and international criteria from NeuPSIG) or fibromyalgia (revised ACR criteria)
  • Stable concomitant medications for pain for at least one month
  • Able to fill out questionnaires and understand and speak French

Exclusion Criteria:

  • Contraindications to rTMS
  • Prior treatment with rTMS
  • Progressive severe condition (eg cancer)
  • Psychosis
  • Psychoactive drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active rTMS
Deep rTMS with H coil targeting the motor cortex bilaterally
Device: Deep active rTMS with Hesed coil
This brain neurostimulation method targets the motor cortex bilaterally
Device: Sham rTMS with Hesed coil
This brain sham neurostimulation method targets the motor cortex bilaterally
Placebo Comparator: Sham rTMS
Sham rTMS with H coil targeting the motor cortex bilaterally
Device: Deep active rTMS with Hesed coil
This brain neurostimulation method targets the motor cortex bilaterally
Device: Sham rTMS with Hesed coil
This brain sham neurostimulation method targets the motor cortex bilaterally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effects of rTMS versus sham rTMS on pain relief at 13 weeks
Time Frame: 13 weeks
Pain relief scale from the Brief Pain Inventory rated from 0 to 100 %
13 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effects of rTMS vs sham on average pain intensity
Time Frame: Each follow up visit at the pain center for up to 13 weeks
Average pain intensity from the Brief Pain Inventory rated from 0 to 10 on a 0-10 numerical pain scale
Each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on pain interference
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
pain interference from Brief Pain Inventory rated from 0 to 70 (total score)
Baseline then each follow up visit at the pain center for up to 13 weeks
Side effects of rTMS or sham
Time Frame: Each follow up visit at the pain center for up to 13 weeks
Any side effects reported by the patients assessed at each visit after each treatment session and rated as mild, moderate or severe
Each follow up visit at the pain center for up to 13 weeks
Comparison of the efficacy of rTMS on the primary outcome between patients with neuropathic pain and fibromyalgia
Time Frame: Week 13
Comparison of both populations on the pain relief scale from the Brief Pain Inventory (0-100 %)
Week 13
Blinding assessment
Time Frame: 13 weeks
Blindinq questionnaire at 13 weeks(end of the study)
13 weeks
Patient global impression of change
Time Frame: 13 weeks
Patient global impression of change at 13 weeks (from much improved to much deteriorated)
13 weeks
Self-reported pain intensity
Time Frame: Baseline then every day at the same time of day (morning or evening)
Average pain intensity from past 24 hours based on 0-10 numerical pain scale
Baseline then every day at the same time of day (morning or evening)
Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
pain intensity on 0-10 numerical rating scale
Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on pain as its least from Brief Pain Inventory
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
pain intensiy on 0-10 numerical rating scale
Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on pain right now from Brief Pain Inventory
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
pain intensiy on 0-10 numerical rating scale
Baseline then each follow up visit at the pain center for up to 13 weeks
Effects on Global Impression of change assessed by the clinician
Time Frame: 13 weeks (end of the treatment)
Clinician global impression of change (from much improved to much deteriorated)
13 weeks (end of the treatment)
Effects of rTMS vs sham on quality of life
Time Frame: Baseline then each follow up vist at the pain center for up to 13 weeks
Euroqol scale which includes 5 dimensions of quality of life and a 0-100 visual analog scale
Baseline then each follow up vist at the pain center for up to 13 weeks
Effects of rTMS versus sham on anxiety and depressive symptoms
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
Anxiety and depressive symptoms of the Hospital Anxiety and Depressive scale rated from 0 to 21 for anxiety and 0 to 21 for depression
Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on sleep
Time Frame: Baseline then each follow up visit at the pain center for up to 13 weeks
Sleep assessed using the sleep scale from the Medical Outcome Survey
Baseline then each follow up visit at the pain center for up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nadine ATTAL

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nadine ATTAL, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-A00902-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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