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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05451251
Other study ID # 2022-4672
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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