Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05451251

Enrollment

Registered

2022-07-11

Start date

2024-10-15

Completion date

2026-10-31

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigeminal Neuralgia

Keywords

Multiple sclerosis, Deep brain stimulation, Pontine lesion

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.

Interventions

DEVICEDeep brain stimulation

Implantation of deep brain stimulation lead within the pontine lesion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Demonstrating the feasibility of the intervention by assessing protocol completion without deviation	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

Measure	Time frame	Description
Patient acceptability of the procedure	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.
Patient global impression of change	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.
Lead implantation accuracy	24 months	Difference between target and actual lead position
Quality of life progression	24 months	Assessed by the Brief Pain Inventory-Facial (BPI-Facial)
Facial numbness	24 months	Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.
Complications	24 months	Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.
Pain evolution	24 months	Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.

Countries

Canada

Contacts

Primary ContactChristian Iorio-Morin, MD, PhD, FRCS(C)

Christian.Iorio-Morin@usherbrooke.ca819-346-1110

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026