Fibromyalgia SyndromeFMS-TMS-GAITNCT07685379
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
A study testing Active repetitive transcranial magnetic stimulation in people with Fibromyalgia Syndrome, run by Institute of Rheumatology, Serbia at 1 site in Serbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Active repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 15 Sep 2021to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of fibromyalgia based on the revised 2016 American College of Rheumatology criteria.
- A Visual Analogue Scale pain score of at least 4, with pain present for more than 3 months before inclusion in the study.
- Pain resistant to standard analgesics, including paracetamol, nonsteroidal anti-inflammatory drugs, and low-potency opioids, administered at full therapeutic doses.
- If receiving treatment for fibromyalgia, participants had to be on a stable dose for more than 1 month before inclusion in the study.
- No previous treatment with repetitive transcranial magnetic stimulation.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms and Gait in Patients With Primary Fibromyalgia
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.
Read more
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.
Read the detailed description
Fibromyalgia is a chronic pain condition characterized by widespread pain, fatigue, sleep problems, difficulties with memory and concentration, mood symptoms, and reduced quality of life. In addition to these symptoms, many adults with fibromyalgia also experience problems with physical functioning, balance, and walking. Walking is not only a physical activity but also requires attention, planning, and coordination between the brain and body. These demands become even greater when a person walks while performing another task at the same time, such as counting, thinking, or carrying an object. This is called dual-task walking and may reflect challenges that occur in everyday life.
Current drug treatments for fibromyalgia often provide only limited symptom relief and may sometimes affect cognition, balance, or physical functioning. For this reason, non-drug approaches are important in the management of fibromyalgia. Repetitive transcranial magnetic stimulation, or rTMS, is a non-invasive brain stimulation technique that uses magnetic pulses delivered through a coil placed on the scalp. These pulses can influence the activity of brain areas involved in pain processing, mood, attention, cognition, and movement control. The procedure does not require surgery or anesthesia.
This study will investigate the effects of rTMS applied over the left dorsolateral prefrontal cortex, a brain region involved in pain modulation, mood regulation, executive function, attention, and cognitive control of walking. The study is designed to evaluate whether real rTMS can improve walking performance and clinical symptoms in adults with fibromyalgia when compared with sham rTMS.
This will be a single-center, randomized, double-blind, sham-controlled clinical study conducted in adults with primary fibromyalgia. Participants will be adults with fibromyalgia whose diagnosis is confirmed according to established classification criteria. Eligible participants have chronic pain lasting more than three months, pain of at least moderate intensity, and persistent symptoms despite conventional pharmacological treatment. Participants are required to be right-handed and able to understand and sign the informed consent form.
People with other conditions that could explain widespread pain or significantly affect walking, balance, cognition, or safety are not included. These include unstable chronic diseases, inflammatory or autoimmune rheumatic diseases, significant degenerative musculoskeletal conditions affecting gait or balance, major psychiatric disorders, neurological disorders causing motor or cognitive deficits, pregnancy or breastfeeding, active infection, malignancy, high fracture risk, and standard safety contraindications to rTMS such as epilepsy, pacemakers, certain implants, metal in the head, or medicines that substantially lower the seizure threshold.
Participants will be randomly assigned to receive either real rTMS or sham rTMS. Randomization will be performed using a computer-generated allocation sequence, and treatment allocation is concealed. Participants and outcome assessors will be blinded to the assigned treatment. Before randomization, participants will be stratified according to the presence or absence of depressive symptoms, because depression may influence both walking performance and response to rTMS.
In the real rTMS group, stimulation will be applied over the left dorsolateral prefrontal cortex. Before treatment, each participant's individual motor threshold will be determined using stimulation of the left primary motor cortex and recording responses from the contralateral hand muscle. The stimulation target will be then identified using a standard 5-cm method from the motor hotspot. The real rTMS protocol uses high-frequency stimulation at 10 Hz and an intensity based on the individual motor threshold. Each treatment session includes repeated stimulation trains and a total of 2,000 magnetic pulses per day. Participants will receive 10 daily sessions over two weeks, on working days, with a weekend break.
In the sham rTMS group, stimulation will be delivered using a sham coil placed over the same scalp region. Sham stimulation will be designed to look and sound similar to real rTMS but does not provide effective therapeutic brain stimulation. The number of sessions, session structure, stimulation schedule, and overall procedure are otherwise the same as in the real rTMS group. This comparison allows the study to evaluate whether any observed effects are due to active brain stimulation rather than expectation, attention from healthcare staff, or participation in the study.
The main outcome of the study will be the change in walking performance from before to after treatment, especially during dual-task walking. Walking will be measured using an electronic walkway system. Participants walk at their usual comfortable speed during simple walking and during different dual-task conditions. These include walking while carrying a glass of water, walking while performing a mental task, and walking while performing both the motor and mental tasks together. The walking assessment measures spatiotemporal gait parameters such as cycle time, stride length, swing time, double support time, and variability of these measures.
The study will also evaluate several clinical outcomes that are important to people with fibromyalgia. These include pain intensity, pain severity and pain interference with daily activities, depressive symptoms, anxiety symptoms, sleep quality and sleep-related problems, fatigue, health-related quality of life, cognitive function, and overall fibromyalgia impact. These outcomes will be assessed using validated questionnaires and clinical instruments before and after the treatment period.
The main hypothesis is that adults with fibromyalgia who receive real rTMS will show greater improvement than those who receive sham rTMS. The study expects that real rTMS may improve walking performance, particularly during more demanding dual-task walking, and may also reduce pain, fatigue, mood symptoms, sleep problems, cognitive difficulties, and overall fibromyalgia-related burden.
Safety will be monitored throughout the treatment period. Participants will be asked about possible adverse effects, including scalp or site discomfort, headache, neck pain, nausea, dizziness, or other symptoms. Serious adverse events will be also monitored, although serious complications from rTMS are rare when standard safety procedures are followed.
By combining objective walking assessment with patient-reported outcomes, this study aims to provide a more complete understanding of how rTMS may affect both symptoms and daily functioning in fibromyalgia. The findings may help clarify whether stimulation of the left dorsolateral prefrontal cortex could be a useful additional non-drug treatment approach for adults with fibromyalgia, particularly for symptoms and functional limitations that affect everyday life.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Active repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
- Keywords
- Fibromyalgia, Transcranial Magnetic Stimulation, Prefrontal Cortex, Patient Reported Outcome Measures, Gait Analysis
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive transcranial magnetic stimulationDevice
Also called Active rTMS
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.
Sham repetitive transcranial magnetic stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Pain intensity was assessed using the Visual Analogue Scale for pain. Scores are recorded on a 100-mm line, with higher scores indicating greater pain intensity. The outcome was evaluated as the change from baseline to post-treatment.
Measured: 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
Pain severity and pain interference with daily activities were assessed using the Brief Pain Inventory-Short Form. Higher scores indicate greater pain burden. The outcome was evaluated as the change from baseline to post-treatment.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in depressive symptoms from baseline to post-treatment
Depressive symptoms were assessed using the Beck Depression Inventory, a 21-item self-report questionnaire. Higher scores indicate greater depression severity. The outcome was evaluated as the change from baseline to post-treatment.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in anxiety symptoms from baseline to post-treatment
Anxiety symptoms were assessed using the Beck Anxiety Inventory. Higher scores indicate greater anxiety severity. The outcome was evaluated as the change from baseline to post-treatment.
Measured: 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
Sleep quality and sleep-related problems were assessed using the Medical Outcomes Study Sleep Scale. The scale evaluates sleep disturbance, snoring, awakening with shortness of breath or headache, sleep adequacy, sleep quantity, daytime sleepiness, Sleep Problems Index I, and Sleep Problems Index II. Higher scores on sleep disturbance, daytime sleepiness, and sleep problem indices indicate greater sleep impairment, whereas higher sleep adequacy scores indicate better perceived sleep adequacy.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in fatigue from baseline to post-treatment
Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Lower scores indicate greater fatigue severity. The outcome was evaluated as the change from baseline to post-treatment.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in health-related quality of life from baseline to post-treatment
Health-related quality of life was assessed using the 36-Item Short Form Health Survey. The questionnaire evaluates physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Physical Component Summary and Mental Component Summary scores were also calculated. Higher scores indicate better perceived health status and quality of life.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in cognitive function from baseline to post-treatment
Cognitive function was assessed using the Montreal Cognitive Assessment. Lower scores indicate poorer cognitive performance. The outcome was evaluated as the change from baseline to post-treatment.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in fibromyalgia impact from baseline to post-treatment
Fibromyalgia-related disease impact and functional impairment were assessed using the Revised Fibromyalgia Impact Questionnaire. Higher scores indicate greater fibromyalgia severity and poorer quality of life. The outcome was evaluated as the change from baseline to post-treatment.
Measured: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Incidence of adverse events during treatment
Safety was assessed by recording adverse events during the treatment period. Reported adverse events were grouped into predefined categories, including site discomfort, headache, neck pain, nausea, dizziness, and other adverse events.
Measured: During the 10-session treatment protocol, approximately 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Sep 2021
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Rheumatology, Serbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Principal investigator, Goran Radunovic, Institute of Rheumatology, Serbia
- Investigators
- Goran L Radunović, MD, PhD, Principal investigator, Medical Faculty, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685379
- Sponsor's protocol ID
- No 29/16 on 27.08.2021.
- Acronym
- FMS-TMS-GAIT
- Status last verified
- Mar 2025
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results of this study will be made available upon reasonable request from the corresponding author. Data will be shared for scientifically justified research purposes after review and approval of the request.
Publications
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.
PubMed 18058946Carrasco-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.
PubMed 35341042Ceron-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.
PubMed 30366245Goes 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.
PubMed 22230426Radunovic 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.
PubMed 34446109
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms and Gait in Patients With Primary Fibromyalgia
- ClinicalTrials.gov ID
- NCT07685379
- Acronym / sponsor ID
- FMS-TMS-GAIT / No 29/16 on 27.08.2021.
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia, Transcranial Magnetic Stimulation, Prefrontal Cortex, Patient Reported Outcome Measures, Gait Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute of Rheumatology, SerbiaUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibromyalgia is a chronic pain condition characterized by widespread pain, fatigue, sleep problems, difficulties with memory and concentration, mood symptoms, and reduced quality of life. In addition to these symptoms, many adults with fibromyalgia also experience problems with physical functioning, balance, and walking. Walking is not only a physical activity but also requires attention, planning, and coordination between the brain and body. These demands become even greater when a person walks while performing another task at the same time, such as counting, thinking, or carrying an object. This is called dual-task walking and may reflect challenges that occur in everyday life.
Current drug treatments for fibromyalgia often provide only limited symptom relief and may sometimes affect cognition, balance, or physical functioning. For this reason, non-drug approaches are important in the management of fibromyalgia. Repetitive transcranial magnetic stimulation, or rTMS, is a non-invasive brain stimulation technique that uses magnetic pulses delivered through a coil placed on the scalp. These pulses can influence the activity of brain areas involved in pain processing, mood, attention, cognition, and movement control. The procedure does not require surgery or anesthesia.
This study will investigate the effects of rTMS applied over the left dorsolateral prefrontal cortex, a brain region involved in pain modulation, mood regulation, executive function, attention, and cognitive control of walking. The study is designed to evaluate whether real rTMS can improve walking performance and clinical symptoms in adults with fibromyalgia when compared with sham rTMS.
This will be a single-center, randomized, double-blind, sham-controlled clinical study conducted in adults with primary fibromyalgia. Participants will be adults with fibromyalgia whose diagnosis is confirmed according to established classification criteria. Eligible participants have chronic pain lasting more than three months, pain of at least moderate intensity, and persistent symptoms despite conventional pharmacological treatment. Participants are required to be right-handed and able to understand and sign the informed consent form.
People with other conditions that could explain widespread pain or significantly affect walking, balance, cognition, or safety are not included. These include unstable chronic diseases, inflammatory or autoimmune rheumatic diseases, significant degenerative musculoskeletal conditions affecting gait or balance, major psychiatric disorders, neurological disorders causing motor or cognitive deficits, pregnancy or breastfeeding, active infection, malignancy, high fracture risk, and standard safety contraindications to rTMS such as epilepsy, pacemakers, certain implants, metal in the head, or medicines that substantially lower the seizure threshold.
Participants will be randomly assigned to receive either real rTMS or sham rTMS. Randomization will be performed using a computer-generated allocation sequence, and treatment allocation is concealed. Participants and outcome assessors will be blinded to the assigned treatment. Before randomization, participants will be stratified according to the presence or absence of depressive symptoms, because depression may influence both walking performance and response to rTMS.
In the real rTMS group, stimulation will be applied over the left dorsolateral prefrontal cortex. Before treatment, each participant's individual motor threshold will be determined using stimulation of the left primary motor cortex and recording responses from the contralateral hand muscle. The stimulation target will be then identified using a standard 5-cm method from the motor hotspot. The real rTMS protocol uses high-frequency stimulation at 10 Hz and an intensity based on the individual motor threshold. Each treatment session includes repeated stimulation trains and a total of 2,000 magnetic pulses per day. Participants will receive 10 daily sessions over two weeks, on working days, with a weekend break.
In the sham rTMS group, stimulation will be delivered using a sham coil placed over the same scalp region. Sham stimulation will be designed to look and sound similar to real rTMS but does not provide effective therapeutic brain stimulation. The number of sessions, session structure, stimulation schedule, and overall procedure are otherwise the same as in the real rTMS group. This comparison allows the study to evaluate whether any observed effects are due to active brain stimulation rather than expectation, attention from healthcare staff, or participation in the study.
The main outcome of the study will be the change in walking performance from before to after treatment, especially during dual-task walking. Walking will be measured using an electronic walkway system. Participants walk at their usual comfortable speed during simple walking and during different dual-task conditions. These include walking while carrying a glass of water, walking while performing a mental task, and walking while performing both the motor and mental tasks together. The walking assessment measures spatiotemporal gait parameters such as cycle time, stride length, swing time, double support time, and variability of these measures.
The study will also evaluate several clinical outcomes that are important to people with fibromyalgia. These include pain intensity, pain severity and pain interference with daily activities, depressive symptoms, anxiety symptoms, sleep quality and sleep-related problems, fatigue, health-related quality of life, cognitive function, and overall fibromyalgia impact. These outcomes will be assessed using validated questionnaires and clinical instruments before and after the treatment period.
The main hypothesis is that adults with fibromyalgia who receive real rTMS will show greater improvement than those who receive sham rTMS. The study expects that real rTMS may improve walking performance, particularly during more demanding dual-task walking, and may also reduce pain, fatigue, mood symptoms, sleep problems, cognitive difficulties, and overall fibromyalgia-related burden.
Safety will be monitored throughout the treatment period. Participants will be asked about possible adverse effects, including scalp or site discomfort, headache, neck pain, nausea, dizziness, or other symptoms. Serious adverse events will be also monitored, although serious complications from rTMS are rare when standard safety procedures are followed.
By combining objective walking assessment with patient-reported outcomes, this study aims to provide a more complete understanding of how rTMS may affect both symptoms and daily functioning in fibromyalgia. The findings may help clarify whether stimulation of the left dorsolateral prefrontal cortex could be a useful additional non-drug treatment approach for adults with fibromyalgia, particularly for symptoms and functional limitations that affect everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Active repetitive transcranial magnetic stimulationParticipants 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. |
| Sham rTMS | Sham comparator | Device: Sham repetitive transcranial magnetic stimulationParticipants 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of fibromyalgia based on the revised 2016 American College of Rheumatology criteria.
- A Visual Analogue Scale pain score of at least 4, with pain present for more than 3 months before inclusion in the study.
- Pain resistant to standard analgesics, including paracetamol, nonsteroidal anti-inflammatory drugs, and low-potency opioids, administered at full therapeutic doses.
- If receiving treatment for fibromyalgia, participants had to be on a stable dose for more than 1 month before inclusion in the study.
- No previous treatment with repetitive transcranial magnetic stimulation.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active repetitive transcranial magnetic stimulationAlso: Active rTMSActive 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 | Active rTMS |
| Sham repetitive transcranial magnetic stimulationSham 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. | Device | Sham rTMS |
Primary outcome
Change in dual-task gait parameters from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
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.
10 secondary outcomes
Change in pain intensity from baseline to post-treatment
Time frame: 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
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in depressive symptoms from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in anxiety symptoms from baseline to post-treatment
Time frame: 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
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in fatigue from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in health-related quality of life from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in cognitive function from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Change in fibromyalgia impact from baseline to post-treatment
Time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.
Incidence of adverse events during treatment
Time frame: During the 10-session treatment protocol, approximately 2 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 18058946Yogev-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.
- Background: PubMed 35341042Carrasco-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.
- Background: PubMed 30366245Ceron-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.
- Background: PubMed 22230426Goes 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.
- Background: PubMed 34446109Radunovic 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results of this study will be made available upon reasonable request from the corresponding author. Data will be shared for scientifically justified research purposes after review and approval of the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran L Radunović, MD, PhD principal investigator
Medical Faculty, University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive transcranial magnetic stimulation in people with Fibromyalgia Syndrome, run by Institute of Rheumatology, Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dual-task gait parameters from baseline to post-treatment (time frame: Baseline and immediately after completion of the 10-session treatment protocol, approximately 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685379, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.