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Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome

Key facts

Who runs it
Izmir Katip Celebi University
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
30 people, planned
Started
13 Mar 2025
Expected to end
1 Apr 2027
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Intermittent theta-burst stimulation
  • Sham Intermittent theta-burst stimulation
Record updated
18 March 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • Being between the ages of 18-65
  • Being diagnosed with fibromyalgia syndrome (according to 2016 criteria)
  • Average pain intensity of NRS ≥ 4/10
  • Fibromyalgia treatment was stable for the last 3 months and no treatment change was planned during the study

Who cannot take part

  • Serious neurological diseases (increased intracranial pressure, presence of space-occupying lesions in the brain, history of epilepsy, presence of cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, history of previous head trauma causing loss of consciousness)
  • Alcohol or drug addiction
  • Having received TMS treatment before
  • Taking benzodiazepine, gabapentin/pregabalin or anticonvulsant medications that have the potential to interfere with intermittent theta burst stimulation treatment or have taken them within the last 4 weeks
  • Having a clinical condition that would constitute a contraindication for TMS (metallic implant, cardiac pacing, pregnancy, epilepsy, head trauma, history of cranial operation...)
  • Presence of malignancy
  • Systemic rheumatologic diseases
  • History of major depression/personality disorder or psychosis
  • Major orthopedic problems limiting activities of daily living (gait disturbance or fracture sequelae limiting joint mobility, prostheses, nerve-tendon injuries)
  • Pregnant or planning pregnancy or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Research on repetitive transcranial magnetic stimulation therapy in fibromyalgia syndrome (FMS) is increasing rapidly. High-frequency rTMS administration to FMS patients is reported to restore intracortical facilitation and provide successful pain relief. This finding supports restoration of cortical stimulation as one of the possible mechanisms of action for rTMS. One treatment protocol is intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS). Although there are many treatment protocols, there are few widely accepted treatment schemes in the literature. In fibromyalgia syndrome, there is no study in the literature. It was planned to include at least 30 patients aged 18-65 years who were admitted to İzmir Katip Çelebi University Atatürk Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic or hospitalized in the ward and diagnosed with fibromyalgia syndrome according to the 2016 criteria. This study has a prospective, parallel group, randomized, sham-controlled study design. A total of 30 fibromyalgia patients will be randomized into 2 groups and will receive a total of 10 sessions of transcranial magnetic stimulation to the primary motor cortex with intermittent theta bust stimulation technique or sham application. Patients will continue their current fibromyalgia treatment.Numeric Rating Scale-pain intensity (NRS-pain), revised Fibromyalgia Impact Questionnaire (FIQR), Pain Catastrophizing Scale (PCS), Hospital Depression Anxiety Scale (HADS) will be used in the evaluation of the patients.

The 2 groups in the trial

  • Active stimulation groupTreatment being tested

    Patients will receive intermittent theta burst stimulation (iTBS) to the primary motor cortex, one session per day for a total of 10 sessions.

    Treatment: Intermittent theta-burst stimulation

  • Sham stimulation groupSham treatment, for comparison

    Patients will receive sham treatment for one session per day for a total of 10 sessions.

    Treatment: Sham Intermittent theta-burst stimulation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effect of Intermittent Theta Burst Stimulation to the Primary Motor Cortex on Pain Intensity, Pain Catastrophizing, Quality of Life and Mood in Fibromyalgia Patients
Fit questions
Built from NCT06746922, who can take part
Record updated
18 March 2025