Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05451251

Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Trigeminal Neuralgia Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Facial Nerve Diseases Facial Neuralgia Immune System Diseases Mouth Diseases Multiple Sclerosis Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1H 5H3, Canada

Location status: Recruiting

Location contact

Mélodie Grondin-Lavigne, MD MSc candidate

CONTACT

[email protected]

819-346-1110 ext. 15130

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep brain stimulation

Device

Implantation of deep brain stimulation lead within the pontine lesion

Primary outcomes

  1. Demonstrating the feasibility of the intervention by assessing protocol completion without deviation

    Time frame: 24 months

    Protocol completion defined by:

    • Lead implantation with success
    • Adjustment of stimulation parameters to minimize adverse effects
    • Minimal follow-up of 6 months after intervention

Secondary outcomes

  1. Lead implantation accuracy

    Time frame: 24 months

    Difference between target and actual lead position

  2. Pain evolution

    Time frame: 24 months

    Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.

  3. Facial numbness

    Time frame: 24 months

    Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.

  4. Complications

    Time frame: 24 months

    Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.

  5. Quality of life progression

    Time frame: 24 months

    Assessed by the Brief Pain Inventory-Facial (BPI-Facial)

  6. Patient acceptability of the procedure

    Time frame: 24 months

    Assessed by a Likert scale with a maximum score of 8. A low score on this scale indicates low acceptability of the surgical procedure, while a high score indicates high acceptability.

  7. Patient global impression of change

    Time frame: 24 months

    Assessed by The Patient Global Impression of Change (PGIC) questionnaire with a maximum score of 18. A low score indicates a low impression of change while a high score indicates a high impression of change.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

819-346-1110 ext. 16365

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 11, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.