NCT03309813

Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain

A Feasibility Study of Focused Ultrasound to Perform Bilateral Medial Thalamotomy for the Treatment of Chronic Trigeminal Neuropathic Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.

Detailed description

This study is to show that for patients with treatment-refractory chronic trigeminal neuropathic pain, ExAblate Neuro focused ultrasound (FUS) can safely create lesions bilaterally in the thalamic nuclei to reduce pain and provide functional benefits in daily activities. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or a Sham Control procedure. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be un-blinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an un-blinded fashion, as long as they still qualify for ExAblate treatment.

Conditions

• Trigeminal Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Transcranial ExAblate	ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
DEVICE	Sham Transcranial ExAblate	Sham ExAblate Thalamotomy procedure
DEVICE	Crossover Transcranial Exablate	Subjects randomized to the Sham Exablate could opt for the Crossovover Transcranial Exablate Arm (Exablate Thalamotomy) after completing the Month 3 visit in the Sham Arm.

Timeline

• Start date: 2017-12-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2017-10-16
• Last updated: 2023-10-03
• Results posted: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study