NCT03658694: TMSFFI

Repetitive Transcranial Magnetic Stimulation of Relief of Fibromyalgia Pain

Completed NA Last updated 5 September 2024

What this trial tests

NA trial testing Conventional rTMS - study 1 in Fibromyalgia in 80 participants. Completed in 1 March 2023.

Timeline

1 April 2019

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 April 2019
Primary completion	1 March 2023
Estimated completion	1 March 2023
Sites	6 locations across France, Japan, Brazil

Drugs / interventions tested

• Conventional rTMS - study 1
• Sham rTMS - study 1
• Conventional rTMS - study 2
• Patterned rTMS - stage 2

Conditions studied

• Fibromyalgia — all drugs for Fibromyalgia →

Sponsor

University of Sao Paulo

Who can join

Adults 18 to 80, female only, with Fibromyalgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There are currently several points concerning rTMS for pain relief that have a huge impact in the practical application of rTMS in clinical practice, but which have not been approached by previous studies. Also, an even more important issue is the frequency of the sessions in each treatment protocol. The idea of performing stimulation in chronic pain patients on a consecutive daily basis for long-term treatments seem unrealistic and potentially costly. However, it has been reported in animals, healthy subjects and FM patients that the analgesic effects of rTMS can outlast the stimulation session for several minutes and even days. This has led to the proposal that pain treatment with rTMS could be performed in consecutive daily induction sessions, followed by spaced (weekly, fortnightly and even monthly) maintenance sessions. This approach is similar to what is performed routinely in patients with major depression treated by rTMS to the dorsolateral prefrontal cortex, and has successfully been tested in FM patients in a single- center study. Should this approach prove effective in larger prospective multicentric studies, rTMS could enter the armamentarium of non-invasive, non- pharmacological, low-adverse event therapeutic options to relieve fibromyalgia- related pain and associate symptoms. Hence, our aim is to conduct a multicentric international clinical trial on the influence of rTMS in the control of pain in a consecutive adaptive trial design where conventional rTMS (10Hz) and patterned rTMS (theta-burst) will be studied. Stimulations will be performed in a clinical practice-friendly approach, where daily maintenance sessions will be followed by weekly, and fortnightly stimulation sessions. There have been very scarce adaptive trials in the pain and non-invasive stimulation fields. This methodological approach allows for the use of lower number of patients in consecutive trials and, among other qualities, it allows for the imputation of data from the first trial into the second one, thus decreasing the duration of the studies and the number of participants.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motor cortex repetitive transcranial magnetic stimulation in fibromyalgia: a multicentre randomised controlled trial.
   Silva VA, Baptista AF, Fonseca AS, Carneiro AM, et al · · 2025 · cited 13× · PMID 40087077 · DOI 10.1016/j.bja.2024.12.045
2. Chronic Pain: Epidemiology, Pathophysiology, and Clinical Management.
   Shang Z, Tian Z, Wang Z, Yang Z, et al · · 2026 · PMID 42100792 · DOI 10.1002/mco2.70756
3. Investigation of predictors of pain relief with high-frequency repetitive motor cortex transcranial magnetic stimulation among people with fibromyalgia.
   Lins CC, Fonseca AS, Martins PN, Oliveira JCB, et al · · 2025 · PMID 41046849 · DOI 10.1016/j.neucli.2025.103109