NCT05475340

Open Label Study for the Use of Transcranial Ultrasound Treatment of Tremor

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase I open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with tremor as a results of Parkinson's Disease or Essential Tremor.

Detailed description

This study is designed to evaluate the safety and efficacy of focused ultrasound in patients with Parkinson's Disease or Essential Tremor characterized by tremor. The safety of this protocol will be closely monitored and data will be used to determine whether any significant safety issues exist when using focused ultrasound. Adverse events will be noted whenever they occur but will be recorded at the time of the procedure and throughout routine follow-ups, which will persist weekly throughout the duration of the active study protocol. Patients deemed potentially appropriate candidates for focused ultrasound therapy will be treated with 8 sessions of transcranial ultrasound, each of which consists of 10 to 30 minutes of active administration. Clinical and safety outcome measures will be obtained throughout and after completion of the study protocol.

Conditions

• Tremor
• Parkinson Disease
• Essential Tremor

Interventions

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

Timeline

• Start date: 2022-07-13
• Primary completion: 2024-07-13
• Completion: 2024-08-13
• First posted: 2022-07-26
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study