Recruiting
Phase 1

Deep Brain Stimulation

Sponsor:

Université de Sherbrooke

Code:

NCT05451251

Conditions

Trigeminal Neuralgia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Deep brain stimulation

Study Details

Brief summary:

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.

Conditions

Trigeminal Neuralgia

Study ID

NCT05451251

Start date

Oct 15, 2024

Status verified date

Nov, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Deep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Interventions

Deep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Primary outcome measure

  • Demonstrating the feasibility of the intervention by assessing protocol completion without deviation [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Christian Iorio-Morin, MD, PhD, FRCS(C)

819-346-1110Christian.Iorio-Morin@usherbrooke.ca

Locations

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5H3

Contacts

Mélodie Grondin-Lavigne, MD MSc candidate

819-346-1110melodie.grondin-lavigne@usherbrooke.ca

More Information

Sponsor

Université de Sherbrooke

Last update posted

Dec 12, 2024

Last verified

Nov, 2024

Keywords

  • Multiple sclerosis
  • Deep brain stimulation
  • Pontine lesion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2024-12-12.