Repetitive Transcranial Magnetic Stimulation of Relief of Fibromyalgia Pain

Summary

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.

Conditions

• Fibromyalgia

Interventions

PROCEDURE

Conventional rTMS - study 1

Patients will be undergoing to 10Hz transcranial magnetic stimulation session

PROCEDURE

Sham rTMS - study 1

Patients will be undergoing to sham transcranial magnetic stimulation session

PROCEDURE

Conventional rTMS - study 2

Patients will be undergoing to 10Hz transcranial magnetic stimulation session

PROCEDURE

Patterned rTMS - stage 2

Patients will be undergoing to theta-burst transcranial magnetic stimulation session

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Daniel Ciampi de Andrade, MD, PhD · Pain Center, Department of Neurology, University of Sao Paulo, Sao Paulo, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2023-03-01

Completion

2023-03-01

Countries

• Brazil
• France
• Japan

Study Locations