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NCT Number: NCT06250491

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

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).

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Key information

Conditions

Neuropathic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inserm U987, Boulogne-Billancourt, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep active rTMS with Hesed coil

Device

This brain neurostimulation method targets the motor cortex bilaterally

Sham rTMS with Hesed coil

Device

This brain sham neurostimulation method targets the motor cortex bilaterally

Primary outcomes

  1. 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 %

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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 %)

  6. Blinding assessment

    Time frame: 13 weeks

    Blindinq questionnaire at 13 weeks(end of the study)

  7. Patient global impression of change

    Time frame: 13 weeks

    Patient global impression of change at 13 weeks (from much improved to much deteriorated)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nadine ATTAL

CONTACT

[email protected]

0033149095931

Sponsors and collaborators

Lead sponsor

Nadine ATTAL

Other

Registry information

Official study title

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

Acronym: H-FINEP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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