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

• Sponsor: Université de Sherbrooke (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05451251
• Collaborator: (none)
• Enrollment: 6
• Arm: 1
• Anticipated Duration (Months): 28.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia	Device: Deep brain stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Deep Brain Stimulation for Refractory Trigeminal Neuralgia With a Demyelinating Pontine Lesion: a Pilot Study
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2024
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deep brain stimulation Implantation of deep brain stimulation lead within the pontine demyelinating lesion	Device: Deep brain stimulation; Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Lead implantation accuracy [24 months]

   Difference between target and actual lead position

2. Pain evolution [24 months]

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

3. Complications [24 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Université de Sherbrooke

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT05451251
• Other Study ID Numbers: 2022-4672
• First Posted: Jul 11, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Université de Sherbrooke: Multiple sclerosis; Deep brain stimulation
• Additional relevant MeSH terms: Trigeminal Neuralgia; Neuralgia

Study Results

No Results Posted as of Jul 14, 2022