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NCT03475797: StimO

Evaluation of Occipital Nerve Stimulation in Intractable Occipital Neuralgias

Terminated NA Last updated 11 October 2021
What this trial tests

NA trial testing Occipital nerve stimulation in Occipital Neuralgia in 22 participants. Terminated before completion.

Timeline
20 April 2018
Primary endpoint
26 June 2021
3 September 2021

Quick facts

Lead sponsorNantes University Hospital
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment22
Start date20 April 2018
Primary completion26 June 2021
Estimated completion3 September 2021
Sites10 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 85, any sex, with Occipital Neuralgia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Occipital Nerve Stimulation for Refractory Occipital Neuralgia: A Multicenter, Randomized, Controlled Trial [StimO Study]
    Ravaillault S, Alipour H, Leger F, Labarre J, et al · · 2026
  2. Occipital Nerve Stimulation for Refractory Occipital Neuralgia: A Multicenter, Randomized, Controlled Trial [StimO Study].
    Ravaillault S, Alipour H, Leger F, Labarre J, et al · · 2026 · PMID 41827338 · DOI 10.3390/jcm15051922

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Other Nantes University Hospital trials

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