Magnetic Brain Stimulation for Pain in Small Fiber Neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the use of repetitive transcranial magnetic stimulation to reduce neuropathic pain in adults with biopsy-confirmed idiopathic small fiber neuropathy. Participants will receive active rTMS or sham stimulation to the brain, with the aim of determining pain relief and changes in daily functioning. The study also looks at whether repeated maintenance sessions can sustain benefits and how rTMS affects pain qualities, overall quality of life, and safety. Eligibility requires adults 18 or older with stable, high-intensity pain for at least 12 weeks and no major nerve damage or other exclusionary conditions. The trial is led by Maastricht University Medical Center with collaboration from Princess Beatrix Muscle Foundation and will take place at Maastricht University Medical Centre in the Netherlands.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years of age or older.
* Skin-biopsy proven idiopathic SFN.
* Pain intensity (maximum pain) rated ≥5 on the PI-NRS, that must have existed for at least 12 weeks before the study.
* Written informed consent.

Exclusion Criteria:

* Signs of large nerve fiber dysfunction (i.e., weakness, loss of vibration sense, hyporeflexia or areflexia, abnormal nerve conduction studies).
* Identifiable underlying cause of SFN (diabetes, SCN9A/SCN10A/SCN11A mutations, hypothyroidism, vitamin B12 deficiency, monoclonal gammopathy, alcohol abuse (more than 5 IU/day), malignancies, or drugs that cause neuropathy).
* Implanted ferromagnetic devices or other magnetic-sensitive metal implants close to the magnetic coil.
* History of epilepsy.
* Using pain medication that has changed in the 30 days prior to randomization.
* Pregnancy.
* Mentally challenged subjects unable to give independent informed consent.
* Clinically significant or unstable psychiatric disorder including major depression, (history of) substance abuse and other major disorders in accordance with DSM-V,

Where it's running

• Maastricht University Medical Centre +
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Janneke G.J. Hoeijmakers, MD, PhD — Maastricht University Medical Centre +
• Study coordinator: Eva C.M. Gruintjes, MD
• Email: eva.gruintjes@mumc.nl
• Phone: +31 433876584

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.