Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion: a Pilot Study

RecruitingPhase 1MS (type not specified)NCT05451251

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Deep brain stimulation

What it measured

Main measures

  • Demonstrating the feasibility of the intervention by assessing protocol completion without deviation

    24 months

    SafetyFeasibility

Other measures (7)

  • Lead implantation accuracy

    24 months

  • Pain evolution

    24 months

    Pain
  • Facial numbness

    24 months

  • Complications

    24 months

    Safety
  • Quality of life progression

    24 months

    PainQuality of life (reported by participants)
  • Patient acceptability of the procedure

    24 months

    Feasibility
  • Patient global impression of change

    24 months

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Adults of at least 18 years old * Refractory trigeminal neuralgia : failure of at least 3 drugs and at least two lesioning surgical interventions (radiosurgery, percutaneous rhizotomy, or open rhizotomy). * Pontine lesion proved by MRI in contact with trigeminal nerve tract

Exclusion criteria

* Absolute contraindication to MRI * Medical contraindication to the procedure

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine lesion, as is usually seen in the context of multiple sclerosis. These patients usually have severe intractable facial pain and current medical and surgical options generally fail to achieve long lasting pain relief. Hoping to improve pain control in this population, the investigators of this trial propose a novel technique consisting of implanting a deep brain stimulation lead within the pontine lesion to modulate the generation of pain signals.

Papers

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    History

      1. Started

        Oct 2024

      2. Main results due

        Oct 2025

      3. Finished

        Oct 2026

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