A Study Comparing Real and Sham Repetitive Transcranial Magnetic Stimulation in Adults With Fibromyalgia, Assessing Effects on Pain, Fatigue, Sleep, Mood, Quality of Life, Cognition, and Walking Under Usual and Dual-task Conditions

Summary

Fibromyalgia is a chronic condition that causes widespread pain and is often accompanied by fatigue, poor sleep, mood symptoms, memory and concentration difficulties, and reduced quality of life. Many adults with fibromyalgia also experience limitations in daily physical functioning. These limitations may include slower or less stable walking, reduced walking endurance, and greater difficulty walking while performing another task at the same time, such as counting or carrying out a mental task.

This clinical study is designed to evaluate the effects of repetitive transcranial magnetic stimulation, also called rTMS, in adults with fibromyalgia. rTMS is a non-invasive brain stimulation technique that delivers magnetic pulses through the scalp to influence activity in specific brain areas involved in pain processing, mood regulation, and physical function. The procedure does not require surgery or anesthesia.

Participants in this study are randomly assigned to receive either real rTMS or sham rTMS. Sham rTMS is designed to look and feel similar to the real procedure but does not deliver active therapeutic brain stimulation. Comparing real and sham rTMS allows researchers to assess whether any observed improvements are related to the active treatment rather than to expectation or participation in the study.

The study evaluates whether real rTMS can improve symptoms and function in adults with fibromyalgia. Outcomes include pain, fatigue, mood, sleep, quality of life, cognition, and walking performance. Walking is assessed during usual walking and during dual-task walking, when participants walk while also performing another task. These assessments are used to better understand how fibromyalgia affects everyday functioning and whether rTMS may help improve both symptoms and objective physical performance.

The main hypothesis is that participants who receive real rTMS will show greater improvement than those who receive sham rTMS. It is expected that real rTMS may reduce pain and related symptoms, improve quality of life and cognitive or emotional functioning, and have a favorable effect on walking performance, especially under more demanding dual-task conditions.

Conditions

• Fibromyalgia Syndrome

Interventions

DEVICE

Active repetitive transcranial magnetic stimulation

Active high-frequency repetitive transcranial magnetic stimulation delivered over the left dorsolateral prefrontal cortex using a figure-of-eight coil. Stimulation was delivered at 10 Hz and 130% of the individually determined motor threshold, with 2,000 pulses per session over 10 daily sessions during two weeks.

DEVICE

Sham repetitive transcranial magnetic stimulation

Sham repetitive transcranial magnetic stimulation delivered over the left dorsolateral prefrontal cortex using a dedicated sham coil. The sham coil reproduced the acoustic characteristics of active stimulation while preventing effective cortical stimulation. The session schedule and stimulation structure were identical to the active rTMS arm.

Sponsors & Collaborators

• University of Belgrade

  collaborator OTHER

• Institute of Rheumatology, Serbia

  lead OTHER

Principal Investigators

• Goran L Radunović, MD, PhD · Medical Faculty, University of Belgrade

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2025-03-30

Completion

2025-03-30

Countries

• Serbia

Study Locations