NCT04497363

Focused Ultrasound for the Treatment of ADHD Symptoms

Open Label Study for the Use of Transcranial Ultrasound Treatment of Attention Deficit Hyperactive Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this open label study is to evaluate longer term tolerability and potential effectiveness of transcranial ultrasound in people with attention deficit hyperactive disorder (ADHD).

Detailed description

The primary cortical regions thought to be implicated in ADHD include the prefrontal, orbitofrontal, and anterior cingulate cortices. A possible treatment approach for ADHD would employ a process designed to promote healthier function of the anterior cingulate region. The anterior cingulate in particular appears to be implicated in the activation of cognitive control networks, and has been posited as an area of interest for therapeutic research on ADHD. The subjects in this research study will be recruited through medical practice and enrolled in an 8-week protocol to undergo 8 consecutive weekly ultrasound sessions.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	Brainsonix Pulsar 1002	Each participant will undergo 8 consecutive weekly sessions (each session is 10 minutes long) of focused ultrasound with the Brainsonix Pulsar 1002 device.

Timeline

• Start date: 2020-07-01
• Primary completion: 2025-10-30
• Completion: 2026-03-02
• First posted: 2020-08-04
• Last updated: 2022-09-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study