NCT06512324

Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Biomedical Discoveries and Neuroscientific Foundations LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or generalized anxiety disorder (GAD). The main questions it aims to answer are: 1. Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)? 2. Which factors have a minimal causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)? Participants already undergoing TMS as part of their treatment plan for MDD/GAD answer survey questions about their symptoms before, during, and up to 1 year post-treatment. Factors affecting clinical outcomes such as stimulation parameters, behavioral factors, physiological factors, patient characteristics, and pharmacological factors, are also recorded.

Conditions

• Major Depressive Disorder
• MDD
• Generalized Anxiety Disorder
• GAD
• Depression
• Anxiety

Interventions

Type	Name	Description
DEVICE	Ampa One TMS System	Transcranial Magnetic Stimulation

Timeline

• Start date: 2024-06-27
• Primary completion: 2028-08-30
• Completion: 2029-12-31
• First posted: 2024-07-22
• Last updated: 2024-07-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study