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NCT06209645: PERSOSTIM

Non-invasive Personalized Transcranial Cortical Neurostimulation for Pain Relief

Not yet recruiting NA Last updated 17 April 2024
What this trial tests

NA trial testing tDCS (Transcranial Direct Current Stimulation) in Drug-resistant Neuropathic Pain in 50 participants. Not yet recruiting.

Timeline
1 September 2024
Primary endpoint
1 March 2029
1 March 2029

Quick facts

Lead sponsorHospices Civils de Lyon
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment50
Start date1 September 2024
Primary completion1 March 2029
Estimated completion1 March 2029

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 80, any sex, with Drug-resistant Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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Data sources for this page

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