Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06209645

Non-invasive Personalized Transcranial Cortical Neurostimulation for Pain Relief

Led by Hospices Civils de Lyon · Updated on 2026-05-08

50

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Neuropathic pain is a public health problem with less than 50% of patients being relieved by drug treatments. Surgically implanted motor cortex stimulation represents an invasive therapeutic solution capable of relieving a significant proportion of drug-resistant patients (1 in 2); it cannot, however, be offered to all patients, and is not morbidity-free. Non-invasive motor cortex stimulation techniques have been refined over the last decade, in particular transcranial repetitive magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), which provide pain relief among almost half of drug-resistant patients with few or no side effects. To be efficient, cortical stimulation requires the activation of multiple distant networks involved in the cognitive and motivational response to pain; stimulation frequency is a crucial parameter for activating these mechanisms. The match between cortical stimulation frequency and the intrinsic neuronal frequency of the stimulated cortex has recently been suggested as a key determinant of clinical effect. Indeed, the transmission efficiency of an oscillatory network increases when its intrinsic frequency matches that of the stimulus applied to it. Given that human sensorimotor networks spontaneously oscillate at frequencies around 10 and 20 Hertz (Hz), this match could underlie the superior efficacy of transcranial stimulation at these frequencies. The hypothesis of the study is that the analgesic effect of cortical stimulation will be enhanced if the stimulation frequency resonates with the spontaneous oscillations of the underlying cortex, thus facilitating its connectivity with the remote structures involved in pain control. The investigators propose to test this hypothesis in a population of patients with drug-resistant neuropathic pain, referred to the Pain Evaluation and Treatment Center (CETD) of the Neurological hospital, at the Hospices Civils de Lyon. The overall aim of the project is to compare the efficacy of stimulation at each individual's own rate of oscillation of the motor cortex, against a "classic" stimulation protocol, and against placebo stimulation.

CONDITIONS

Official Title

Non-invasive Personalized Transcranial Cortical Neurostimulation for Pain Relief

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 80 years
  • Neuropathic pain lasting more than one year
  • Previous unsuccessful treatment with tricyclic or tetracyclic antidepressants, antiepileptics, and a combination of morphine with serotonin-norepinephrine reuptake inhibitors, unless contraindicated
  • Average pain intensity of at least 4 out of 10 in the month before joining
  • Recipient or beneficiary of a social security scheme
Not Eligible

You will not qualify if you...

  • Chronic pain not caused by neuropathy or pain linked to progressive diseases
  • Active epilepsy, whether treated or untreated
  • Unhealed scalp wound near EEG or stimulation electrode sites
  • Pregnant or breastfeeding women
  • Difficulty understanding or communicating, preventing daily and weekly pain assessments
  • Under legal guardianship or protection
  • Deprived of liberty, under psychiatric care, or admitted to a health or social facility for reasons other than research
  • Participation in other studies that interfere with this one

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre d'Evaluation et de Traitement de la Douleur, Hôpital Neurologique Pierre Wertheimer

Bron, France, 69677

Actively Recruiting

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Research Team

C

Charbel SALAMEH, MD

CONTACT

G

GARCIA-LARREA Luis, MD., PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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