aiTBS and rTMS for Chronic Neuropathic Pain: see if brain stimulation helps

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 double-blind, sham-controlled trial compares accelerated intermittent theta burst stimulation (aiTBS) and conventional high-frequency rTMS against sham treatment in adults with chronic neuropathic pain for at least six months. Participants receive non-invasive brain stimulation sessions over motor cortex targets to see if they reduce pain intensity and improve function, with safety monitoring and neurophysiological assessments. The study also seeks predictors of response using clinical questionnaires and resting-state EEG data. Eligible participants are adults 18–79 with stable pain and treatment, and peripheral or central neuropathic pain fulfilling DN4 criteria. Outcomes include pain relief and safety, with randomization ensuring unbiased comparison.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age over 18 years and less than 80 years
2. Average pain intensity ≥ 4/10 on the numerical scale of the Brief Pain Inventory at screening and randomization
3. Pain present for at least 4 days per week
4. Persistent pain for at least 6 months
5. Stable pharmacological treatment for pain for at least 1 month prior to the study.
6. Peripheral or central neuropathic pain (postherpetic neuralgia, painful neuropathies, nerve lesions, radiculopathy, trigeminal neuralgia, stabilized multiple sclerosis, spinal cord lesion or stroke) fulfilling criteria for probable or definite neuropathic pain; and scoring ≥ 4 out of 10 on the DN4 questionnaire
7. Informed consent
8. Patients who can be followed for the whole duration of the study
9. Patients affiliated to social security in France

Exclusion Criteria:

1. Ongoing litigation
2. Contraindication to rTMS :

   * implanted electronic devices and/or conductive objects near the coil: patients with an active implanted device activated or controlled by physiological signals (e.g. pacemakers, implanted cardioverter defibrillators \[ICD\], vagus nerve stimulators \[VNS\] and portable cardioverter defibrillators \[WCD\], ocular implants, deep 16 brain stimulation, drug chambers/pumps, intracardiac leads) even if the device has been removed.
   * Non-removable metal objects near the coil: Patients with a conductive implant, ferromagnetic or made of any other metal sensitive to magnetic fields, in the head or at a distance of less than 30 cm from the coil (e.g. cochlear implant, implanted electrodes/pacemakers, aneurysm clips or coils, stents and bullet fragments).
3. Current drug or psychoactive substance abuse (DSM V)
4. Pregnancy or lactation
5. Epilepsia or past epilepsia
6. Progressive unsable pathology (eg cancer)
7. Current psychosis according to DSM V criteria
8. Presence of other pain more severe than that justifying inclusion
9. Lack of correct completion of pain self-assessment diaries between inclusion and randomisation (at least 4 weekly pain scores over 7 days),
10. Subject unable to understand informed consent, under guardianship or curatorship
11. Patients participating in another research protocol within 30 days prior to inclusion.
12. Patient who has already received a treatment with rTMS

Where it's running

• Hopital Ambroise-Paré INSERM U987, 9 Av. Charles de Gaulle
  Boulogne-Billancourt, Île-de-France Region, France Recruiting

Study contacts

• Study coordinator: Nadine ATTAL
• Email: nadine.attal@aphp.fr
• Phone: 0033149095931

Similar studies

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

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• Using low dose naltrexone to treat pain in HIV patients

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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.