Observing How Brain Stimulation Treatment Affects Depression and Anxiety Symptoms
Tracks symptoms in people with depression or anxiety already receiving magnetic brain stimulation treatment.
Plain-language title generated from the registry record
Registry title: Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
Key facts
- Where
- Encinitas and Plano, United StatesSee the 2 sites
Where in United States
- Kind Health GroupEncinitas, United StatesNo longer taking part
- Salience Research InstitutePlano, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Biomedical Discoveries and Neuroscientific Foundations LLC
- Trial code
- NCT06512324
- Record updated
- 22 July 2024
- Original description
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:Read full original descriptionShow less
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
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.
Inclusion: 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: Are considered unsuitable for outpatient care due to illness severity or other factors in the opinion of their prescribing physician,; Have been found to have any contraindication to TMS treatment by 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.