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

Primary Purpose

Occipital Neuralgia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Occipital nerve stimulation
Optimal Medical Management
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Occipital Neuralgia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Caen
  • CHU de Clermont-Ferrand
  • Hôpitaux Civils de Colmar
  • CHU Limoges
  • Hôpital Pierre Wertheimer
  • CHU de Nantes
  • CHU de Nice
  • Hôpital Lariboisière
  • Hôpital Foch
  • CHU de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Occipital Nerve Stimulation (ONS)

Optimal Medical Management (OMM)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 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
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)
Comparison of maximum pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Average pain (using Visual Analogic Scale)
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
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
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
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
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)
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)
Comparison of the quality of life (using Hamilton Anxiety and Depression (HAD) scale) between the 2 groups (ONS/OMM)

Full Information

First Posted
March 16, 2018
Last Updated
October 4, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03475797
Brief Title
Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias
Acronym
StimO
Official Title
Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision to stop the study prematurely due to insufficient inclusion.
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
June 26, 2021 (Actual)
Study Completion Date
September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occipital Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Occipital Nerve Stimulation (ONS)
Arm Type
Experimental
Arm Description
Occipital nerve stimulation with percutaneous or surgical lead plus optimal medical management
Arm Title
Optimal Medical Management (OMM)
Arm Type
Active Comparator
Arm Description
Optimal Medical Management according to what is done in routine clinical practice
Intervention Type
Device
Intervention Name(s)
Occipital nerve stimulation
Intervention Description
Occipital nerve stimulation with percutaneous or surgical lead
Intervention Type
Other
Intervention Name(s)
Optimal Medical Management
Intervention Description
Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.
Primary Outcome Measure Information:
Title
Efficacy of occipital nerve stimulation
Description
Compare the decrease of pain (evaluated by visual analogic scale) after 6 months of treatment between the 2 groups (ONS / OMM)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months
Description
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
Time Frame
3 months
Title
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months
Description
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
Time Frame
6 months
Title
Maximum pain (using Visual Analogic Scale)
Description
Comparison of maximum pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Time Frame
Up to 6 months
Title
Average pain (using Visual Analogic Scale)
Description
Comparison of average pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Time Frame
Up to 6 months
Title
Relative decrease of pain (using Visual Analogic Scale) at 3 months
Description
Comparison of the relative decrease of pain (using Visual Analogic Scale) at 3 months between the 2 groups (ONS/OMM)
Time Frame
3 months
Title
Relative decrease of pain (using Visual Analogic Scale) at 6 months
Description
Comparison of the relative decrease of pain (using Visual Analogic Scale) at 6 months between the 2 groups (ONS/OMM)
Time Frame
6 months
Title
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months
Description
Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months between the 2 groups (ONS/OMM)
Time Frame
3 months
Title
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months
Description
Comparison of the efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months between the 2 groups (ONS/OMM)
Time Frame
6 months
Title
Quality of life (using EQ-5D-5L questionnaire)
Description
Comparison of the quality of life (using EQ-5D-5L questionnaire) between the 2 groups (ONS/OMM)
Time Frame
Up to 6 months
Title
Quality of life (using Hamilton Anxiety and Depression (HAD) scale)
Description
Comparison of the quality of life (using Hamilton Anxiety and Depression (HAD) scale) between the 2 groups (ONS/OMM)
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14009
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpitaux Civils de Colmar
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06001
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hôpital Foch
City
Paris
ZIP/Postal Code
92151
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias

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