Investigating the Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Brain in People With Fibromyalgia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Rochester

About this trial

The first goal of this study is to see how brain activity changes in people with fibromyalgia after they get a treatment called rTMS (repetitive transcranial magnetic stimulation). Researchers are looking at how the parts of the brain that control movement (called motor cortices) respond to this treatment.

The second goal is to find out if the changes in brain activity are different between the right and left sides of the brain, depending on which side gets the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female aged 18 to 65, right-handed, with no racial/ethnic restrictions.

A diagnosis of fibromyalgia by a qualified physician according to the American College of Rheumatology 2016 criteria

Must have a history of fibromyalgia pain for a duration ≥ 3 months, as it is included in the diagnostic criteria.

Must have pain intensity equal or greater than 4/10 on the numerical rating scale (NRS) at enrollment.

Disqualifiers

Inability to provide informed consent.

Age outside the studied range (i.e., < 18, > 65).

Patients planning to change their medications during trial.

Participants who are currently receiving other alternative therapies during trial (e.g., physiotherapy, acupuncture).

Trial design

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Other intervention

    Using rTMS, which is a procedure that uses magnetic fields to stimulate nerve cells in the brain, to investigate its potential analgesic effects in fibromyalgia.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: right M1 rTMSActive comparator 1 intervention
Group B: Left M1 rTMSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in Primary Motor Cortex (M1) Connectopy Profile

Resting-state fMRI will be used to derive connectopy embeddings of the primary motor cortex (M1). Connectopy embeddings from the stimulated side will be extracted from significant baseline-defined clusters. A single value per participant is derived by averaging the embedding values within this cluster. Higher scores indicate increased similarity to healthy reference profiles (improved functional connectivity), while lower scores indicate deviation from healthy reference patterns (reduced functional connectivity).

Time frame
Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).

Secondary outcomes

1

Mean Change in Pain Intensity (Numeric Rating Scale, NRS)

Self-reported average pain over 7 days using the Numeric Rating Scale (0 = "no pain at all" to 10 = "worst pain possible"). A single number is derived as the mean of daily ratings over 7 days. Lower scores indicate reduced pain intensity, while higher scores indicate worse pain intensity.

Time frame
Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).
2

Mean Change in Pressure Pain Threshold (PPT)

Pressure pain threshold (PPT) will be measured using a pressure algometer (Wagner Inc.). Pressure will be applied at a constant rate until participants indicate pain perception. The threshold (kg/cm²) will be recorded. A single value is derived by averaging three threshold readings from the target site. Higher thresholds indicate reduced pain sensitivity (improvement), while lower thresholds indicate increased pain sensitivity (worsening).

Time frame
Baseline and post-treatment (within 7 days of completing rTMS sessions )
3

Mean Change in Fatigue (Patient-Reported Outcomes Measurement Information System-PROMIS Fatigue 13a Subscale)

Fatigue will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 13a subscale, which ranges from 13 to 65. Higher scores indicate greater fatigue severity (worsening), whereas lower scores indicate less fatigue (improvement).

Time frame
Baseline and post-treatment (within 7 days of completing rTMS sessions).
4

Mean Change in Sleep Disturbance (Patient-Reported Outcomes Measurement Information System - PROMIS Sleep Disturbance 8a Subscale)

Sleep disturbance will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 8a subscale, which ranges from 8 to 40. Higher scores indicate greater sleep disturbance (worsening), whereas lower scores indicate improved sleep.

Time frame
Baseline and post-treatment (within 7 days of completing rTMS sessions).

Other outcomes

Sponsors and contacts

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