NCT06250491

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2024Apr 2027

First Submitted

Initial submission to the registry

January 23, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 27, 2026

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

January 23, 2024

Last Update Submit

March 25, 2026

Conditions

Neuropathic PainFibromyalgia

Keywords

Neuropathic pain - Fibromyalgia - deep rTMS

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • Effects of rTMS vs sham on average pain intensity

    Each follow up visit at the pain center for up to 13 weeks

  • Effects of rTMS vs sham on pain interference

    Baseline then each follow up visit at the pain center for up to 13 weeks

  • Effects of rTMS vs sham on quality of life

    Baseline then each follow up vist at the pain center for up to 13 weeks

  • Side effects of rTMS or sham

    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

    Week 13

  • +9 more secondary outcomes

Study Arms (2)

Active rTMS

EXPERIMENTAL

Deep rTMS with H coil targeting the motor cortex bilaterally

Device: Deep active rTMS with Hesed coilDevice: Sham rTMS with Hesed coil

Sham rTMS

PLACEBO COMPARATOR

Sham rTMS with H coil targeting the motor cortex bilaterally

Device: Deep active rTMS with Hesed coilDevice: Sham rTMS with Hesed coil

Interventions

Deep active rTMS with Hesed coilDEVICE

This brain neurostimulation method targets the motor cortex bilaterally

Active rTMSSham rTMS
Sham rTMS with Hesed coilDEVICE

This brain sham neurostimulation method targets the motor cortex bilaterally

Active rTMSSham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inserm U987

Boulogne-Billancourt, 92100, France

RECRUITING

Centre d'Evaluation et de Traitement de la douleur

Paris, 75014, France

NOT YET RECRUITING

MeSH Terms

Conditions

NeuralgiaFibromyalgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Nadine ATTAL

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Nadine ATTAL

CONTACT

0033149095931nadine.attal@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 9, 2024

Study Start

January 30, 2024

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

March 27, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)