Assessing different rTMS protocols for treating neuropathic pain
Classical, Spaced, or Accelerated Transcranial Magnetic Stimulation of Motor Cortex for Treating Neuropathic Pain: a 3-arm Parallel Non-inferiority Study
This study is testing three different types of brain stimulation to see which one helps people with chronic nerve pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Institut pour la Pratique et l'Innovation en PSYchologie appliquée (Institut Pi-Psy) Academic / other |
| Locations | 1 site (Créteil, Île-de-France Region) |
| Trial ID | NCT06964243 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of three different repetitive transcranial magnetic stimulation (rTMS) protocols in treating patients with chronic peripheral neuropathic pain. A total of 36 patients aged 18 to 80 will be randomly assigned to receive either classical high-frequency rTMS (CHF-rTMS), spaced high-frequency rTMS (SHF-rTMS), or accelerated intermittent theta burst stimulation (ACC-iTBS). The study aims to compare the analgesic efficacy of these protocols to determine the most effective treatment approach for neuropathic pain. Participants will be recruited from the Clinical Neurophysiology department at Henri Mondor University Hospital in France.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with chronic peripheral neuropathy and a pain score of 4 or higher on a numerical rating scale.
Not a fit: Patients with neurological disorders, psychiatric illnesses, or contraindications to TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective non-drug treatment option for patients suffering from neuropathic pain.
How similar studies have performed: Previous studies have shown that rTMS can be effective for neuropathic pain, but this specific comparison of protocols is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) existence of a definite peripheral neuropathy on both clinical and neurophysiological grounds, present for at least 6 months; * (2) neuropathic pain clearly related to the neuropathy, as defined by a score ≥ 4/10 on the questionnaire "Douleur Neuropathique en 4 Questions" (DN4) ; * (3) a score ≥ 4/10 on a 0-10 numerical rating scale (NRS) concerning the average intensity of daily ongoing pain; * (4) age between 18 and 80 years; * (5) affiliation with the social security system; * (6) ability to provide signed informed consent. Exclusion Criteria: * (1) concomitant neurological (neurodegenerative disorders, migraine, epilepsy, stroke, tumor) or psychiatric illness; * (2) contraindications related to TMS (intracranial ferromagnetic material); * (3) drug-resistant or active epilepsy.
Where this trial is running
Créteil, Île-de-France Region
- Henri Mondor University Hospital — Créteil, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Jean-Pascal Lefaucheur, MD, PhD
- Email: Jean-pascal.lefaucheur@aphp.fr
- Phone: 800-555-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.