NCT04485208

Focused Ultrasound for the Treatment of Neuropathic Pain

Open Label Study for the Use of Focused Transcranial Ultrasound for Treatment of Neuropathic Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

A possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei. This study is designed to employ focused ultrasound technology to target the VPM and VPL thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.

Detailed description

The present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. The subjects in this research study will be recruited through medical practice. Participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. Targeting for treatment will be based on patient MRI scans using stereotaxic techniques.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound	The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the anterior cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix Pulsar 1002 ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.

Timeline

• Start date: 2020-06-30
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2020-07-24
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study