Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05451251
• Other study ID #: 2022-4672
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: February 2025

Study information

• Verified date: July 2022
• Source: Université de Sherbrooke
• Contact: Christian Iorio-Morin, MD
• Phone: 819-346-1110
• Email: Christian.Iorio-Morin[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the feasibility of deep brain stimulation for refractory trigeminal neuralgia due to a pontine demyelinating 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: February 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults of at least 18 years old

• Refractory trigeminal neuralgia (failure of at least 3 drugs and at least one surgical intervention)

• Demyelinating pontine lesion proved by MRI in contact with trigeminal nerve tract

Exclusion Criteria:

• Absolute contraindication to MRI

• Medical contraindication to the procedure

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Device:
• Deep brain stimulation
Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrating the feasibility of the intervention by assessing protocol completion without deviation	Protocol completion defined by: Lead implantation with success; Adjustment of stimulation parameters to minimize adverse effects; Minimal follow-up of 6 months after intervention	24 months
Secondary	Lead implantation accuracy	Difference between target and actual lead position	24 months
Secondary	Pain evolution	Evolution of pain severity after the intervention according to the modified Barrow Neurological Institute (mBNI) grading scale.	24 months
Secondary	Complications	Complications arising from the intervention according to the Common Terminology Criteria for Adverse Events (CTCAE) grading scale.	24 months