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

NCT07685379 | Completed

• 1 other identifier: No 29/16 on 27.08.2021.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Transcranial Magnetic Stimulation; Prefrontal Cortex; Patient Reported Outcome Measures; Gait Analysis

Outcome Measures

Primary Outcomes (1)

• Change in dual-task gait parameters from baseline to post-treatment

  The primary outcome is the between-group difference between active repetitive transcranial magnetic stimulation and sham stimulation in pre-post change in dual-task gait parameters. Gait was assessed using the GAITRite electronic walkway during dual-task walking conditions, including motor, mental, and combined motor-cognitive tasks. Spatiotemporal gait parameters included cycle time, stride length, swing time, double support time, and the coefficients of variation of these parameters. Changes were expressed as absolute delta values and relative percentage delta values from baseline to post-treatment.

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

Secondary Outcomes (10)

• Change in pain intensity from baseline to post-treatment

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

• Change in pain severity and pain interference from baseline to post-treatment

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

• Change in depressive symptoms from baseline to post-treatment

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

• Change in anxiety symptoms from baseline to post-treatment

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

• Change in sleep quality and sleep-related problems from baseline to post-treatment

  Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.

Study Arms (2)

Active rTMS

EXPERIMENTAL

Participants assigned to this arm will receive active repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex. Stimulation will be delivered at 10 Hz and 130% of the individually determined motor threshold. Each session will include 2,000 pulses, delivered as 40 trains of 50 pulses, with 5-second stimulation trains and 20-second inter-train intervals. Treatment will consist of 10 daily sessions over two weeks, administered on working days.

Device: Active repetitive transcranial magnetic stimulation

Sham rTMS

SHAM COMPARATOR

Participants assigned to this arm will receive sham repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex using a dedicated sham coil. Sham stimulation will reproduce the acoustic characteristics of active rTMS while preventing effective cortical stimulation. The stimulation parameters, number of pulses, train duration, inter-train interval, number of sessions, and treatment schedule were identical to the active rTMS arm.

Device: Sham repetitive transcranial magnetic stimulation

Interventions

Active repetitive transcranial magnetic stimulation DEVICE

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.

Also known as: Active rTMS

Active rTMS

Sham repetitive transcranial magnetic stimulation DEVICE

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.

Sham rTMS

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of fibromyalgia based on the revised 2016 American College of Rheumatology criteria.
• Pain resistant to standard analgesics, including paracetamol, nonsteroidal anti-inflammatory drugs, and low-potency opioids, administered at full therapeutic doses.
• No previous treatment with repetitive transcranial magnetic stimulation.

You may not qualify if:

• Inability to provide informed consent.
• Other chronic conditions, diseases, or disorders that may cause diffuse pain, such as endocrine or metabolic diseases.
• Other degenerative, orthopedic, or surgical diseases of the musculoskeletal system that significantly affect gait, including the use of crutches or a walking cane.
• Presence of a chronic inflammatory rheumatic disease.
• Presence of a systemic autoimmune disease.
• Primary psychiatric diagnosis, including previously diagnosed severe depressive disorder, generalized anxiety disorder, or psychosis.
• Psychoactive substance abuse.
• Neurological diseases that have caused or may cause cognitive or motor deficits.
• Specific conditions such as active infections, malignancy, osteoporosis with high fracture risk, fractures, and similar conditions.
• Contraindications to repetitive transcranial magnetic stimulation, including epilepsy, central nervous system trauma, brain surgery, intracranial hemorrhage, implanted pacemaker or other metal implant, pregnancy, or breastfeeding.

Sponsors & Collaborators

• University of Belgrade: collaborator
• Institute of Rheumatology, Serbia: lead

Study Sites (1)

Institute of Rheumatology

Belgrade, 11000, Serbia

Location

Related Publications (5)

• Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

  PMID: 18058946 BACKGROUND

• Carrasco-Vega E, Ruiz-Munoz M, Cuesta-Vargas A, Romero-Galisteo RP, Gonzalez-Sanchez M. Individuals with fibromyalgia have a different gait pattern and a reduced walk functional capacity: a systematic review with meta-analysis. PeerJ. 2022 Mar 21;10:e12908. doi: 10.7717/peerj.12908. eCollection 2022.

  PMID: 35341042 BACKGROUND

• Ceron-Lorente L, Valenza MC, Perez-Marmol JM, Garcia-Rios MDC, Castro-Sanchez AM, Aguilar-Ferrandiz ME. The influence of balance, physical disability, strength, mechanosensitivity and spinal mobility on physical activity at home, work and leisure time in women with fibromyalgia. Clin Biomech (Bristol). 2018 Dec;60:157-163. doi: 10.1016/j.clinbiomech.2018.10.009. Epub 2018 Oct 10.

  PMID: 30366245 BACKGROUND

• Goes SM, Leite N, Shay BL, Homann D, Stefanello JM, Rodacki AL. Functional capacity, muscle strength and falls in women with fibromyalgia. Clin Biomech (Bristol). 2012 Jul;27(6):578-83. doi: 10.1016/j.clinbiomech.2011.12.009. Epub 2012 Jan 9.

  PMID: 22230426 BACKGROUND

• Radunovic G, Velickovic Z, Rasic M, Janjic S, Markovic V, Radovanovic S. Assessment of gait in patients with fibromyalgia during motor and cognitive dual task walking: a cross-sectional study. Adv Rheumatol. 2021 Aug 26;61(1):53. doi: 10.1186/s42358-021-00212-5.

  PMID: 34446109 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Goran L Radunović, MD, PhD

  Medical Faculty, University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Goran Radunovic

Model Details: This is a single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. Eligible adults with fibromyalgia were stratified according to baseline depressive status and then randomly assigned in a 1:1 ratio to receive either active repetitive transcranial magnetic stimulation or sham stimulation. Both groups followed the same treatment schedule, consisting of 10 daily sessions over two weeks. Participants and outcome assessors were blinded to treatment allocation. The primary comparison was the change in outcomes from baseline to post-treatment between the active and sham groups.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: September 15, 2021
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: July 6, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will become available after publication of the main study results. Data will be shared upon reasonable request to the corresponding author, after review and approval of the proposed research purpose.
• Access Criteria: De-identified individual participant data and supporting documents will be shared with qualified researchers upon reasonable request to the corresponding author. Requests should include a scientifically justified research proposal, planned analyses, and a data protection plan. Data may be used for research purposes related to fibromyalgia, repetitive transcranial magnetic stimulation, gait, pain, mood, sleep, cognition, quality of life, or related clinical outcomes. Requests will be reviewed by the study investigators, and access will be granted after approval of the proposal and, where appropriate, completion of a data sharing agreement.

Locations

SE (1)