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Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated December 12, 2024 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Secondary endpoints: details revised at 2 of 7 entriesv4
  2. Notable Phase: Not applicable to Phase 1v3 Show 8 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2024 to Oct 15, 2025
    • Start date changed from estimate of Oct 2022 to Oct 15, 2024
    • Study sites: 0 to 1
    • Study completion date: Feb 2025 to Oct 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: 3 to 7
    • Study title shortened, about 1 word
  3. Minor Secondary endpoints: details revised at 2 of 3 entriesv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05451251
Lead Sponsor Université de Sherbrooke
Conditions
(from sponsor)
Trigeminal Neuralgia
Related terms Multiple Sclerosis, Trigeminal Neuralgia
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov