Personalized non-invasive brain stimulation for drug-resistant neuropathic pain
Non-invasive Analgesic Stimulation of the Patient's Motor Cortex With an Oscillating Electric Current at the Dominant Frequency Recorded by EEG
NA · Hospices Civils de Lyon · NCT06209645
This tests personalized non-invasive brain stimulation (tDCS or tACS) to try to reduce chronic drug-resistant neuropathic pain in adults.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT06209645 on ClinicalTrials.gov |
What this trial studies
The trial delivers personalized transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) targeting the motor cortex, with stimulation frequency matched to each patient’s intrinsic brain rhythms to engage pain-related networks. Eligible participants are adults with neuropathic pain for more than one year who have not responded to standard drug treatments. Treatments are non-invasive, given in repeated sessions at a specialized pain center, with daily and weekly pain ratings recorded. The study compares pain outcomes and side effects to determine whether frequency-matched stimulation improves relief compared with typical approaches.
Who should consider this trial
Good fit: Adults aged 18–80 with neuropathic pain for over one year who have failed standard therapies (including antidepressants, antiepileptics, and opioid-SNRI combinations) and can attend regular visits in Bron, France.
Not a fit: Patients with non-neuropathic or progressive pain, active epilepsy, unhealed scalp wounds, pregnancy or breastfeeding, or inability to complete study assessments are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer an effective, low-risk non-surgical option to reduce pain for patients who do not respond to medications.
How similar studies have performed: Previous non-invasive motor cortex stimulation studies (rTMS, tDCS) have produced pain relief in roughly half of drug-resistant patients, while the specific approach of individualized frequency matching is newer and less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 to 80 years * Neuropathic pain of more than one year's duration1 * Failed treatment with tricyclic or tetracyclic antidepressants, antiepileptics and a combination of morphine and a serotonin (5HT) norepinephrine (NA2) reuptake inhibitor, in the absence of contraindication. * Average pain intensity of at least 4/10 in the month preceding the inclusion visit. * Recipient or beneficiary of a social security scheme- Exclusion Criteria: * Chronic non-neuropathic pain or pain associated with progressive pathology, active epilepsy, unhealed scalp wound, impaired comprehension or communication that prevents subjective daily and weekly assessments. * Active epilepsy, treated or not * Unhealed scalp wound adjacent to EEG recording electrodes or transcranial stimulation application (contraindication to Medical Device (DM) use) * Pregnant or breast-feeding women * Inability to understand or follow the ins and outs of the study, in particular the need to assess pain intensity on a daily basis or to trace it, possibly with the help of a third party (comprehension or communication disorders). * People under guardianship, curatorship or legal protection * Persons deprived of their liberty, persons under psychiatric care and persons admitted to a health or social establishment for purposes other than clinical investigation * Participation in other research interfering with the present study.
Where this trial is running
Bron
- Centre d'Evaluation et de Traitement de la Douleur, Hôpital Neurologique Pierre Wertheimer — Bron, France (RECRUITING)
Study contacts
- Principal investigator: Charbel SALAMEH, MD — Central Integration of pain lab (NeuroPain); Lyon Neurocience research center
- Study coordinator: Charbel SALAMEH, MD
- Email: ext-charbel.salameh@chu-lyon.fr
- Phone: 00 33 4 72 35 78 29
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.
Conditions: Drug-resistant Neuropathic Pain