Health TrialsbyHealthPanel

Deep Brain Stimulation for Refractory Trigeminal Neuralgia with a Pontine Lesion

ConditionTrigeminal Neuralgia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absolute contraindication to MRI

Medical contraindication to the procedure

Trial design

Design model

Single group

Treatments tested in this trial

  • Deep brain stimulation

    Device

    Implantation of deep brain stimulation lead within the pontine lesion

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Deep brain stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 months

Secondary outcomes

1

Lead implantation accuracy

Difference between target and actual lead position

Time frame
24 months
2

Pain evolution

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

Time frame
24 months
3

Facial numbness

Assessed by the Barrow Neurological Institute Facial Numbness Scale and a Quantitative Sensory Testing (QST) protocol.

Time frame
24 months
4

Complications

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Source ClinicalTrials.gov
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