NCT04775875

The Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

Open Label Study for the Use of Transcranial Ultrasound Treatment of Obsessive-Compulsive Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the safety and efficacy of ultrasound as a treatment for Obsessive Compulsive disorder.

Detailed description

The present study is being undertaken as an open-label study to evaluate the safety and feasibility of focused ultrasound as an intervention for patients with obsessive compulsive disorder (OCD). Participants in this study will undergo 8 consecutive weekly sessions of transcranial low-intensity focused ultrasound (LIFUP) targeting the caudate of the basal ganglia. 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 for this neurological application. Treatment response will be measured using the Beck Depression \& Anxiety Inventories, the Yale-Brown Obsessive-Compulsive Scale, and the Global Rating of Change Scale.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	Focused Ultrasound	The DWL Doppler ultrasound device enables visual and auditory wave form confirmation of cerebral arteries, and optical tracking technology (eg, 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: 2020-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2021-03-01
• Last updated: 2022-09-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study