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

Primary Purpose

Trigeminal Neuralgia

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Deep brain stimulation

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Multiple sclerosis, Deep brain stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Deep brain stimulation

Arm Description

Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lead implantation accuracy

Difference between target and actual lead position

Pain evolution

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

Complications

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

Full Information

NCT ID

NCT05451251

First Posted

July 5, 2022

Last Updated

July 11, 2022

Sponsor

Université de Sherbrooke

1. Study Identification

Unique Protocol Identification Number

NCT05451251

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

Keywords

Multiple sclerosis, Deep brain stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Deep brain stimulation

Arm Type

Experimental

Arm Description

Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Intervention Type

Device

Intervention Name(s)

Deep brain stimulation

Intervention Description

Implantation of deep brain stimulation lead within the pontine demyelinating lesion

Primary Outcome Measure Information:

Title

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

Description

Protocol completion defined by: Lead implantation with success Adjustment of stimulation parameters to minimize adverse effects Minimal follow-up of 6 months after intervention

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Lead implantation accuracy

Description

Difference between target and actual lead position

Time Frame

24 months

Title

Pain evolution

Description

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

Time Frame

24 months

Title

Complications

Description

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

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Iorio-Morin, MD

Phone

819-346-1110

Ext

16365

Christian.Iorio-Morin@usherbrooke.ca

12. IPD Sharing Statement

Learn more about this trial

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

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