Neuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome
Key facts
- Who runs it
- Istituto Giannina Gaslini
- Where
- Genova, ItalySee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 46 people, planned
- Started
- 31 Mar 2025
- Expected to end
- Mar 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)
- Record updated
- 25 August 2026
Who can take part
- Age
- 10 years to 21 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Subjects aged between 10 and 21 years.Patients with fibromyalgia according to the 1990 criteria of the American College of Rheumatology or Patients with other types of non-inflammatory musculoskeletal pain syndromes.Patients who reported a mean pain score > 4 on a 10-point visual analog scale (VAS) during the two weeks preceding the clinical trial.Disease duration for more than 6 months, no change in drug treatments during the last month, and lack of response to conventional treatments
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 10 and 21 years old?
Where in Italy
- Ronchetti Anna BrunaGenova, ItalyNo longer taking part
About the trial
What the trial wants to find out
The aim of this clinical trial is to see if transcranial electrical stimulation (tES) can help reduce pain and improve quality of life in children and adolescents (ages 10-21, both sexes) with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The main questions are whether active tES works better than sham (placebo) stimulation for pain relief and whether it leads to measurable changes in brain activity.Participants will be randomly assigned to receive either active or sham tES for 20 minutes a day over two weeks. They'll complete questionnaires about their pain and quality of life, do some simple physical and motor tests, and undergo non-invasive brain measurements before and after the intervention. The results will help understand if tES is a safe and effective option for managing chronic pain in young people.
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Specific Aims:
Aim 1a. transcranial stimulation will be associated with significant improvements in pain and functioning (e.g., 30% or greater symptom relief or 20% or greater improvement in QoL) Aim 1b. For each tES condition, estimate mean changes in motor evoked potential (MEP) amplitudes induced by TMS stimulation.
Aim 2. Compare the tES conditions (Active, Sham) in terms of the mean changes in MEP amplitude.
Aim 3. Obtain statistical estimates of variance components needed for the planning of a future study. Therefore, we hypothesize that anodal tES stimulation decreases MEP amplitudes compared to sham tES condition. We further hypothesize that MEP amplitudes are positively correlated. This study will be the first randomized, double-blind, controlled study of tES technology in children as an adjunctive pain management strategy for MPS.
Data from this trial will likely yield information regarding the feasibility and efficacy of tES as a chronic pain-management approach.
The 2 groups in the trial
- Active tESExisting treatment, for comparison
Active tES (transcranial electrical stimulation) is a non-invasive brain stimulation technique that involves applying a low-intensity electrical current (up to 2 mA) to specific areas of the cerebral cortex through electrodes placed on the scalp. In this study, the active tES protocol delivers current for 20 minutes per session, over 10 consecutive days (2 weeks), with the anodal electrode placed over the left primary motor cortex (C3 position, according to the 10-20 EEG system) and the reference electrode over the contralateral supraorbital region. The goal is to modulate cortical excitability and reduce pain in patients with juvenile fibromyalgia or other non-inflammatory musculoskeletal pain syndromes. The procedure is safe, well-tolerated, and monitored for adverse effects
Treatment: Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)
- Sham tESSham treatment, for comparison
Sham tES (transcranial electrical stimulation) is a placebo-controlled procedure designed to mimic the experience of active tES without delivering a sustained electrical current. In this study, for the sham protocol, electrodes are placed in the same positions as for active stimulation. After an initial ramp-up period of 30 seconds, the stimulation fades out over the next 30 seconds, so participants feel the initial tingling sensation but receive no active current for the remainder of the session. At the end of the sham session, stimulation fades in again for 30 seconds and then ends with a final 30-second ramp-down. This method reliably simulates the sensations of active tES and helps reduce expectation bias, while ensuring that no actual neuromodulatory effect is delivered
Treatment: Neuro-modulation of central pain pathways in non inflammatory musculoskeletal pain syndrome (NMJFP)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07785362, who can take part
- Record updated
- 25 August 2026