Status:
TERMINATED
Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias
Lead Sponsor:
Nantes University Hospital
Conditions:
Occipital Neuralgia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Medically intractable pain caused by occipital neuralgia can be very difficult to control with traditional pain management. Peripheral nerve stimulation which is used in migraines and cluster headache...
Eligibility Criteria
Inclusion
- Patients between 18 and 85 years old
- Chronic occipital neuralgias as defined by International Headache Society (IHS) more than 6 months with permanent pain associated or not with paroxysm
- Secondary occipital neuralgias (post-traumatic, post-surgery, major arthrosis, compression or lesion of the occipital nerve …)
- Chronic neuropathic pain according to the Neuropathic Pain Diagnostic Questionnaire (DN4 ≥ 4)
- Maximum pain on VAS ≥ 50/100
- Failure of medical treatment (association of neuropathic medication like antiepileptic and/or antidepressant and/or antalgic treatment like paracetamol, tramadol or morphine) and pain management in a pain Unit including multidisciplinary approach, physiotherapy, block test in C1-C2, radiofrequency rhizolysis, and/or corticosteroid infiltration of C2 according to the criteria defined by Health Authorities for spinal cord stimulation.
- Reduction of pain with Transcutaneous Electrical Nerve Stimulation (TENS) in occipital area
- Neurological examen has to be completed and must be normal except for the occipital neuralgia territory
- A negative pregnancy test for women with childbearing potential
- Women of childbearing potential must use appropriate method(s) of contraception during the clinical trial
- Patients must be capable of giving informed consent and must have signed informed consent
- Affiliation to an appropriate health insurance
Exclusion
- Contraindication to the experimental medical devices
- Titanium related allergies
- Patients with contraindications to general anesthesia
- Complete anaesthesia in the C2/Great occipital nerve territory
- Drug or alcohol addiction
- Psychiatric disorders (psychiatric evaluation)
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol (e.g. cancer with a limited life expectancy)
- Need for intensive nursing care
- Difficulty in follow-up
- Pregnant or lactating women
- Women not using contraception
- Adults under a legal protection regime (guardianship, trusteeship, "sauvegarde de justice")
- Exclusion period for another study
- Simultaneous participation in another clinical trial except if that other trial does not affect the StimO study as approved and documented by the sponsor
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03475797
Start Date
April 20 2018
End Date
September 3 2021
Last Update
October 11 2021
Active Locations (10)
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1
CHU de Caen
Caen, France, 14009
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
3
Hôpitaux Civils de Colmar
Colmar, France, 68024
4
CHU Limoges
Limoges, France, 87000