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Clinical Trial NCT06250491 (H-FINEP) for Neuropathic Pain, Fibromyalgia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia (H-FINEP) 100 Randomized
Clinical Trial NCT06250491 (H-FINEP) is an interventional study for Neuropathic Pain, Fibromyalgia that is recruiting. It started on 30 January 2024 with plans to enroll 100 participants. Led by Nadine ATTAL, it is expected to complete by 30 April 2027. The latest data from ClinicalTrials.gov was last updated on 10 September 2025.
Brief 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 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.
Official Title
Effects of Deep rTMS in Neuropathic Pain or Fibromyalgia : a Bicenter Randomized Sham Controlled Study
Conditions
Neuropathic PainFibromyalgiaOther Study IDs
- H-FINEP
- 2023-A00902-43
NCT ID Number
Start Date (Actual)
2024-01-30
Last Update Posted
2025-09-10
Completion Date (Estimated)
2027-04-30
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalActive rTMS Deep rTMS with H coil targeting the motor cortex bilaterally | Deep active rTMS with Hesed coil This brain neurostimulation method targets the motor cortex bilaterally Sham rTMS with Hesed coil This brain sham neurostimulation method targets the motor cortex bilaterally |
Placebo ComparatorSham rTMS Sham rTMS with H coil targeting the motor cortex bilaterally | Deep active rTMS with Hesed coil This brain neurostimulation method targets the motor cortex bilaterally Sham rTMS with Hesed coil This brain sham neurostimulation method targets the motor cortex bilaterally |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 % | 13 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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) | 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 | 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 | 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 %) | Week 13 |
Blinding assessment | Blindinq questionnaire at 13 weeks(end of the study) | 13 weeks |
Patient global impression of change | Patient global impression of change at 13 weeks (from much improved to much deteriorated) | 13 weeks |
Self-reported pain intensity | 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 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 | 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 | 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 | 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 | 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 | 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) | 13 weeks (end of the treatment) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Contraindications to rTMS
- Prior treatment with rTMS
- Progressive severe condition (eg cancer)
- Psychosis
- Psychoactive drug abuse
Nadine ATTALStudy Responsible Party
Nadine ATTAL, Sponsor-Investigator, Clinical Professor, Hospital Ambroise Paré Paris
Study Central Contact
Contact: Nadine ATTAL, 0033149095931, [email protected]
2 Study Locations in 1 Countries
Inserm U987, Boulogne-Billancourt, 92100, France
Nadine ATTAL, Contact, 0033149095931, [email protected]
Didier BOUHASSIRA, Sub-Investigator
Serge PERROT, Principal Investigator
Recruiting
Centre d'Evaluation et de Traitement de la douleur, Paris, 75014, France
Serge PERROT, Contact, [email protected]
Anne-Priscille TROUVIN, Sub-Investigator
Not yet recruiting