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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250491
Other study ID # 2023-A00902-43
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2024
Est. completion date April 30, 2027

Study information

Verified date February 2024
Source Hospital Ambroise Paré Paris
Contact Nadine ATTAL
Phone 0033149095931
Email nadine.attal@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 then every 2 to 3 weeks for up to 10 weeks).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 30, 2027
Est. primary completion date January 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Device:
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

Locations

Country Name City State
France Inserm U987 Boulogne-Billancourt
France Centre d'Evaluation et de Traitement de la douleur Paris

Sponsors (1)

Lead Sponsor Collaborator
Nadine ATTAL

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Blinding assessment Blindinq questionnaire at 13 weeks(end of the study) 13 weeks
Secondary Patient global impression of change Patient global impression of change at 13 weeks (from much improved to much deteriorated) 13 weeks
Secondary 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)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
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