Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias

NCT ID: NCT03475797

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2021-09-03

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.

Conditions

Occipital Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Occipital Nerve Stimulation (ONS)

Occipital nerve stimulation with percutaneous or surgical lead plus optimal medical management

Group Type: EXPERIMENTAL

Occipital nerve stimulation

Intervention Type: DEVICE

Occipital nerve stimulation with percutaneous or surgical lead

Optimal Medical Management

Intervention Type: OTHER

Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.

Optimal Medical Management (OMM)

Optimal Medical Management according to what is done in routine clinical practice

Group Type: ACTIVE_COMPARATOR

Optimal Medical Management

Intervention Type: OTHER

Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.

Interventions

Occipital nerve stimulation

Occipital nerve stimulation with percutaneous or surgical lead

Intervention Type: DEVICE

Optimal Medical Management

Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Caen

Caen, , France

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Hôpitaux Civils de Colmar

Colmar, , France

CHU Limoges

Limoges, , France

Hôpital Pierre Wertheimer

Lyon, , France

CHU de Nantes

Nantes, , France

CHU de Nice

Nice, , France

Hôpital Lariboisière

Paris, , France

Hôpital Foch

Paris, , France

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

RC17_0013

Identifier Type: -

Identifier Source: org_study_id