Occipital NeuralgiaStimONCT03475797
Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias
A study testing Occipital nerve stimulation and Optimal Medical Management in people with Occipital Neuralgia, run by Nantes University Hospital at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Occipital Neuralgia
- What is being tested?
- Occipital nerve stimulation and Optimal Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 10 sitesFrance
- Study dates
- 20 Apr 2018to 3 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Caen
Caen, 14009
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Hôpitaux Civils de Colmar
Colmar, 68024
CHU Limoges
Limoges, 87000
Hôpital Pierre Wertheimer
Lyon, 69003
CHU de Nantes
Nantes, 44093
CHU de Nice
Nice, 06001
Hôpital Lariboisière
Paris, 75475
Hôpital Foch
Paris, 92151
CHU de Poitiers
Poitiers, 86021
About this study
Official title: Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
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
- Being tested
- Occipital nerve stimulation, Optimal Medical Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital nerve stimulationDevice
Occipital nerve stimulation with percutaneous or surgical lead
Optimal Medical ManagementOther
Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.
| Study group | Role | What they receive |
|---|---|---|
| Occipital Nerve Stimulation (ONS) | Experimental | Occipital nerve stimulation with percutaneous or surgical lead plus optimal medical management Receives: 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 Receives: Other: Optimal Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: 3 months
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
Measured: 6 months
Maximum pain (using Visual Analogic Scale)
Comparison of maximum pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Measured: Up to 6 months
Average pain (using Visual Analogic Scale)
Comparison of average pain (using Visual Analogic Scale) between the 2 groups (ONS/OMM)
Measured: Up to 6 months
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)
Measured: 3 months
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)
Measured: 6 months
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)
Measured: 3 months
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)
Measured: 6 months
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)
Measured: Up to 6 months
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)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start20 Apr 2018
- Primary completion26 Jun 2021
- Study completion3 Sep 2021
Why it stopped: Sponsor's decision to stop the study prematurely due to insufficient inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occipital NeuralgiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475797
- Sponsor's protocol ID
- RC17_0013
- Acronym
- StimO
- Status last verified
- Oct 2021
- First submitted
- 16 Mar 2018
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ravaillault S, Alipour H, Leger F, Labarre J, Nguyen JM, Pluchon YM, Riant T, Emery E, Nizard J, Raoul S. Occipital Nerve Stimulation for Refractory Occipital Neuralgia: A Multicenter, Randomized, Controlled Trial [StimO Study]. J Clin Med. 2026 Mar 3;15(5):1922. doi: 10.3390/jcm15051922.
PubMed 41827338
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias: a Multicentric, Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT03475797
- Acronym / sponsor ID
- StimO / RC17_0013
- Conditions
- Occipital Neuralgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision to stop the study prematurely due to insufficient inclusion.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occipital Nerve Stimulation (ONS) | Experimental | Device: Occipital nerve stimulation, Other: Optimal Medical ManagementOccipital nerve stimulation with percutaneous or surgical lead plus optimal medical management |
| Optimal Medical Management (OMM) | Active comparator | Other: Optimal Medical ManagementOptimal Medical Management according to what is done in routine clinical practice |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital nerve stimulationOccipital nerve stimulation with percutaneous or surgical lead | Device | Occipital Nerve Stimulation (ONS) |
| Optimal Medical ManagementOptimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc. | Other | Occipital Nerve Stimulation (ONS), Optimal Medical Management (OMM) |
Primary outcome
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)
10 secondary outcomes
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 3 months
Time frame: 3 months
Decrease of medical treatment (i.e. decrease of Medication Quantification Scale (MQS) score) in the ONS group at 6 months
Time frame: 6 months
Maximum pain (using Visual Analogic Scale)
Time frame: Up to 6 months
Average pain (using Visual Analogic Scale)
Time frame: Up to 6 months
Relative decrease of pain (using Visual Analogic Scale) at 3 months
Time frame: 3 months
Relative decrease of pain (using Visual Analogic Scale) at 6 months
Time frame: 6 months
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 3 months
Time frame: 3 months
Efficacy of the treatment (using Migraine Disability Assessment (MIDAS) Test) at 6 months
Time frame: 6 months
Quality of life (using EQ-5D-5L questionnaire)
Time frame: Up to 6 months
Quality of life (using Hamilton Anxiety and Depression (HAD) scale)
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Sponsor's decision to stop the study prematurely due to insufficient inclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 41827338Ravaillault S, Alipour H, Leger F, Labarre J, Nguyen JM, Pluchon YM, Riant T, Emery E, Nizard J, Raoul S. Occipital Nerve Stimulation for Refractory Occipital Neuralgia: A Multicenter, Randomized, Controlled Trial [StimO Study]. J Clin Med. 2026 Mar 3;15(5):1922. doi: 10.3390/jcm15051922.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occipital nerve stimulation and Optimal Medical Management in people with Occipital Neuralgia, run by Nantes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor's decision to stop the study prematurely due to insufficient inclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of occipital nerve stimulation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.