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

Biomedical Discoveries and Neuroscientific Foundations LLC

Status: Invitation-only

Conditions: Major Depressive Disorder; GAD; Generalized Anxiety Disorder; Depression; Anxiety; MDD

Treatments: Device: Ampa One TMS System

Study type: Observational

Funder types: Industry

Identifiers

NCT06512324

BDNF-001

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a primary diagnosis of major depressive disorder (MDD) and/or generalized anxiety disorder (GAD)
• Are receiving outpatient care,
• Voluntarily provide competent consent for treatment,
• Are 12 years of age or older,
• Are able to adhere to the weekly assessment schedule for primary outcome measures,
• Have been assessed by their prescribing physician as suitable candidates for TMS treatment in terms of safety and presenting indication,
• Have consented to undergo a therapeutic course of TMS treatment at one of the participating clinic sites,
• Are able to communicate in the English language.

Exclusion criteria

• Have been found to have any contraindication to TMS treatment by their prescribing physician,
• Are considered unsuitable for outpatient care due to illness severity or other factors in the opinion of their prescribing physician,
• Have active suicidal intent or plan,
• Are unable to adhere to or decline participation in the weekly assessment schedule for primary outcome measures,
• Lack the ability to communicate in the English language.