Status:
NOT_YET_RECRUITING
Non-invasive Personalized Transcranial Cortical Neurostimulation for Pain Relief
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Drug-resistant Neuropathic Pain
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06209645
Start Date
September 1 2024
End Date
March 1 2029
Last Update
April 17 2024
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