Neuropathic PainH-FINEPNCT06250491
Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia
A study testing Deep active rTMS with Hesed coil in people with Neuropathic Pain and Fibromyalgia, run by Nadine ATTAL at 2 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Fibromyalgia
- What is being tested?
- Deep active rTMS with Hesed coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Jan 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindications to rTMS
- Prior treatment with rTMS
- Progressive severe condition (eg cancer)
- Psychosis
- Psychoactive drug abuse
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Inserm U987
Boulogne-Billancourt, 92100
Nadine ATTAL, 0033149095931, nadine.attal@aphp.fr
Didier BOUHASSIRA
- Not yet recruiting
Centre d'Evaluation et de Traitement de la douleur
Paris, 75014
Serge PERROT, serge.perrot@aphp.fr
Anne-Priscille TROUVIN
About this study
Official title: 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).
Read the 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.
- Conditions
- Neuropathic Pain, Fibromyalgia
- Being tested
- Deep active rTMS with Hesed coil, Sham rTMS with Hesed coil
- Keywords
- Neuropathic pain - Fibromyalgia - deep rTMS
- Medical subject headings
- Neuralgia, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep active rTMS with Hesed coilDevice
This brain neurostimulation method targets the motor cortex bilaterally
Sham rTMS with Hesed coilDevice
This brain sham neurostimulation method targets the motor cortex bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Deep rTMS with H coil targeting the motor cortex bilaterally Receives: Device: Deep active rTMS with Hesed coil; Device: Sham rTMS with Hesed coil |
| Sham rTMS | Placebo comparator | Sham rTMS with H coil targeting the motor cortex bilaterally Receives: Device: Deep active rTMS with Hesed coil; Device: Sham rTMS with Hesed coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of rTMS versus sham rTMS on pain relief at 13 weeks
Pain relief scale from the Brief Pain Inventory rated from 0 to 100 %
Measured: 13 weeks
Secondary outcomes (14)
Effects of rTMS vs sham on average pain intensity
Average pain intensity from the Brief Pain Inventory rated from 0 to 10 on a 0-10 numerical pain scale
Measured: Each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on pain interference
pain interference from Brief Pain Inventory rated from 0 to 70 (total score)
Measured: Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on quality of life
Euroqol scale which includes 5 dimensions of quality of life and a 0-100 visual analog scale
Measured: Baseline then each follow up vist at the pain center for up to 13 weeks
Side effects of rTMS or sham
Any side effects reported by the patients assessed at each visit after each treatment session and rated as mild, moderate or severe
Measured: 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
Comparison of both populations on the pain relief scale from the Brief Pain Inventory (0-100 %)
Measured: Week 13
Blinding assessment
Blindinq questionnaire at 13 weeks(end of the study)
Measured: 13 weeks
Patient global impression of change
Patient global impression of change at 13 weeks (from much improved to much deteriorated)
Measured: 13 weeks
Self-reported pain intensity
Average pain intensity from past 24 hours based on 0-10 numerical pain scale
Measured: Baseline then every day at the same time of day (morning or evening)
Effects of rTMS versus sham on anxiety and depressive symptoms
Anxiety and depressive symptoms of the Hospital Anxiety and Depressive scale rated from 0 to 21 for anxiety and 0 to 21 for depression
Measured: Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on pain as its worst from Brief Pain Inventory
pain intensity on 0-10 numerical rating scale
Measured: 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
pain intensiy on 0-10 numerical rating scale
Measured: Baseline then each follow up visit at the pain center for up to 13 weeks
Effects of rTMS vs sham on sleep
Sleep assessed using the sleep scale from the Medical Outcome Survey
Measured: 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
pain intensiy on 0-10 numerical rating scale
Measured: 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
Clinician global impression of change (from much improved to much deteriorated)
Measured: 13 weeks (end of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start30 Jan 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadine ATTAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Nadine ATTAL, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250491
- Sponsor's protocol ID
- 2023-A00902-43
- Acronym
- H-FINEP
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
- ClinicalTrials.gov ID
- NCT06250491
- Acronym / sponsor ID
- H-FINEP / 2023-A00902-43
- Conditions
- Neuropathic Pain, Fibromyalgia
- Keywords
- Neuropathic pain - Fibromyalgia - deep rTMS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nadine ATTALUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Deep active rTMS with Hesed coil, Device: Sham rTMS with Hesed coilDeep rTMS with H coil targeting the motor cortex bilaterally |
| Sham rTMS | Placebo comparator | Device: Deep active rTMS with Hesed coil, Device: Sham rTMS with Hesed coilSham rTMS with H coil targeting the motor cortex bilaterally |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Contraindications to rTMS
- Prior treatment with rTMS
- Progressive severe condition (eg cancer)
- Psychosis
- Psychoactive drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep active rTMS with Hesed coilThis brain neurostimulation method targets the motor cortex bilaterally | Device | Active rTMS, Sham rTMS |
| Sham rTMS with Hesed coilThis brain sham neurostimulation method targets the motor cortex bilaterally | Device | Active rTMS, Sham rTMS |
Primary outcome
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 %
14 secondary outcomes
Effects of rTMS vs sham on average pain intensity
Time frame: 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
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
Side effects of rTMS or sham
Time frame: 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
Blinding assessment
Time frame: 13 weeks
Patient global impression of change
Time frame: 13 weeks
Self-reported pain intensity
Time frame: Baseline then every day at the same time of day (morning or evening)
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
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
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
Effects of rTMS vs sham on sleep
Time frame: 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
Effects on Global Impression of change assessed by the clinician
Time frame: 13 weeks (end of the treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine ATTAL study director
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep active rTMS with Hesed coil in people with Neuropathic Pain and Fibromyalgia, run by Nadine ATTAL at 2 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine ATTAL (0033149095931, nadine.attal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of rTMS versus sham rTMS on pain relief at 13 weeks (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.