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Trial record 3 of 15 for:    Occipital Neuralgia

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 : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE April 20, 2018
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias
Official Title  ICMJE Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Occipital Neuralgia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Occipital Nerve Stimulation (ONS)
    Occipital nerve stimulation with percutaneous or surgical lead plus optimal medical management
    Interventions:
    • Device: Occipital nerve stimulation
    • Other: Optimal Medical Management
  • Active Comparator: Optimal Medical Management (OMM)
    Optimal Medical Management according to what is done in routine clinical practice
    Intervention: Other: Optimal Medical Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sylvie RAOUL, MD, PhD (+33) (0)2 40 16 50 80 sylvie.raoul@chu-nantes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475797
Other Study ID Numbers  ICMJE RC17_0013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nantes University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP