Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias

NCT03475797 | Terminated DMC

• 1 other identifier: RC17_0013
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Efficacy of occipital nerve stimulation

  Compare the decrease of pain (evaluated by visual analogic scale) after 6 months of treatment between the 2 groups (ONS / OMM)

  6 months

Secondary Outcomes (10)

• Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months

  3 months

• Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months

  6 months

• Maximum pain (using Visual Analogic Scale)

  Up to 6 months

• Average pain (using Visual Analogic Scale)

  Up to 6 months

• Relative decrease of pain (using Visual Analogic Scale) at 3 months

  3 months

Study Arms (2)

Occipital Nerve Stimulation (ONS)

EXPERIMENTAL

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

Device: Occipital nerve stimulation; Other: Optimal Medical Management

Optimal Medical Management (OMM)

ACTIVE COMPARATOR

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

Other: Optimal Medical Management

Interventions

Occipital nerve stimulation DEVICE

Occipital nerve stimulation with percutaneous or surgical lead

Occipital Nerve Stimulation (ONS)

Optimal Medical Management OTHER

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

Occipital Nerve Stimulation (ONS); Optimal Medical Management (OMM)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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")
• Simultaneous participation in another clinical trial except if that other trial does not affect the StimO study as approved and documented by the sponsor

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (10)

CHU de Caen

Caen, 14009, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpitaux Civils de Colmar

Colmar, 68024, France

Location

CHU Limoges

Limoges, 87000, France

Location

Hôpital Pierre Wertheimer

Lyon, 69003, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06001, France

Location

Hôpital Lariboisière

Paris, 75475, France

Location

Hôpital Foch

Paris, 92151, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: March 23, 2018
• Study Start: April 20, 2018
• Primary Completion: June 26, 2021
• Study Completion: September 3, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)