TerminatedNot Applicable

Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias

Stopped: Sponsor's decision to stop the study prematurely due to insufficient inclusion.

France22 participantsStarted 2018-04-20

Plain-language 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 can be an alternative for these patients with occipital neuralgias when medical treatment and traditional pain management have failed (drugs for neuropathic pain, infiltrations, psychobehavioral approaches and multidisciplinary approach in a pain center). Occipital nerve stimulation consists to put a lead subcutaneously in front of the occipital nerve and to connect the lead to a pulse generator. A retrospective study of 60 patients was conducted in Nantes University Hospital. The results were good with the Visual Analog Scale (VAS) decreased from 8.4 preoperatively to 2.85 postoperatively. The medical quantification scale (MQS) was reduced to about 50% (18 preoperatively versus 9.9 postoperatively). Stimulation was quiet stable over time with a mean follow-up of 24 months (range 6 to 72 months). The aim of StimO is to confirm this result through a national controlled randomized multicenter study where occipital nerve stimulation will be compared to the optimal medical management.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * Contraindication to the experimental medical devices …

What they're measuring

Efficacy of occipital nerve stimulation

Timeframe: 6 months

Trial details

NCT IDNCT03475797

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-26