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Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias (StimO)

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ClinicalTrials.gov Identifier: NCT03475797
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Occipital Neuralgia Device: Occipital nerve stimulation Other: Optimal Medical Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Occipital Nerve Stimulation (ONS)
Occipital nerve stimulation with percutaneous or surgical lead plus optimal medical management
Device: Occipital nerve stimulation
Occipital nerve stimulation with percutaneous or surgical lead

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

Active Comparator: Optimal Medical Management (OMM)
Optimal Medical Management according to what is done in routine clinical practice
Other: Optimal Medical Management
Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.




Primary Outcome Measures :
  1. Efficacy of occipital nerve stimulation [ Time Frame: 6 months ]
    Compare the decrease of pain (evaluated by visual analogic scale) after 6 months of treatment between the 2 groups (ONS / OMM)


Secondary Outcome Measures :
  1. Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months [ Time Frame: 3 months ]
    Evaluate the decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) after 3 months of occipital nerve stimulation in the ONS group

  2. Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months [ Time Frame: 6 months ]
    Evaluate the decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) after 6 months of occipital nerve stimulation in the ONS group

  3. Maximum pain (using Visual Analogic Scale) [ Time Frame: Up to 6 months ]
    Comparison of maximum pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)

  4. Average pain (using Visual Analogic Scale) [ Time Frame: Up to 6 months ]
    Comparison of average pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)

  5. Relative decrease of pain (using Visual Analogic Scale) at 3 months [ Time Frame: 3 months ]
    Comparison of the relative decrease of pain (using Visual Analogic Scale) at 3 months between the 2 groups (ONS/OMM)

  6. Relative decrease of pain (using Visual Analogic Scale) at 6 months [ Time Frame: 6 months ]
    Comparison of the relative decrease of pain (using Visual Analogic Scale) at 6 months between the 2 groups (ONS/OMM)

  7. Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months [ Time Frame: 3 months ]
    Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months between the 2 groups (ONS/OMM)

  8. Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months [ Time Frame: 6 months ]
    Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months between the 2 groups (ONS/OMM)

  9. Quality of life (using EQ-5D-5L questionnaire) [ Time Frame: Up to 6 months ]
    Comparison of the quality of life (using EQ-5D-5L questionnaire) between the 2 groups (ONS/OMM)

  10. Quality of life (using Hamilton Anxiety and Depression (HAD) scale) [ Time Frame: Up to 6 months ]
    Comparison of the quality of life (using Hamilton Anxiety and Depression (HAD) scale) between the 2 groups (ONS/OMM)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475797


Contacts
Contact: Sylvie RAOUL, MD, PhD (+33) (0)2 40 16 50 80 sylvie.raoul@chu-nantes.fr

Locations
France
CHU de Caen Not yet recruiting
Caen, France, 14009
Contact: Evelyne Emery, MD         
Contact: Marie-Françoise Amiel, MD         
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Jean-Jacques Lemaire, MD         
Contact: Xavier Moisset, MD         
Hôpitaux Civils de Colmar Not yet recruiting
Colmar, France, 68024
Contact: Jimmy Voirin, MD         
Contact: Richard Schalck, MD         
Hôpital Pierre Wertheimer Not yet recruiting
Lyon, France, 69003
Contact: Patrick Mertens, MD         
Contact: Jean-Bernard Caillet, MD         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Sylvie Raoul, MD         
Contact: Julien Nizard, MD         
CHU de Nice Not yet recruiting
Nice, France, 06001
Contact: Denys Fontaine, MD         
Contact: Michel Lantéri-Minet, MD         
Hôpital Lariboisière Not yet recruiting
Paris, France, 75475
Contact: Nouman Aldahak, MD         
Contact: Alain Serrie, MD         
Hôpital Foch Not yet recruiting
Paris, France, 92151
Contact: Béchir Jarraya, MD         
Contact: Marie-Christine Djian-Hallepee, MD         
CHU de Poitiers Not yet recruiting
Poitiers, France, 86021
Contact: Philippe Rigoard, MD         
Contact: Elodie Charrier, MD         
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03475797     History of Changes
Other Study ID Numbers: RC17_0013
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms