Clinical trial NCT03475797: Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias
Official title: Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Occipital Neuralgia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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
* 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

Primary outcomes:
measure: Efficacy of occipital nerve stimulation
timeFrame: 6 months
Secondary outcomes:
measure: Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months
timeFrame: 3 months
measure: Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months
timeFrame: 6 months
measure: Maximum pain (using Visual Analogic Scale)
timeFrame: Up to 6 months
measure: Average pain (using Visual Analogic Scale)
timeFrame: Up to 6 months
measure: Relative decrease of pain (using Visual Analogic Scale) at 3 months
timeFrame: 3 months
measure: Relative decrease of pain (using Visual Analogic Scale) at 6 months
timeFrame: 6 months
measure: Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months
timeFrame: 3 months
measure: Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months
timeFrame: 6 months
measure: Quality of life (using EQ-5D-5L questionnaire)
timeFrame: Up to 6 months
measure: Quality of life (using Hamilton Anxiety and Depression (HAD) scale)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: Hôpital Pierre Wertheimer
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Foch
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: