NCT06512324Enrolling by invitation
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry (OBSERVER)
Source: ClinicalTrials.gov · Last updated 22 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 27 Jun 2024
- Primary completion date
- 30 Aug 2028
- Lead sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLC
- Diseases
- Depression
- NCT number
- NCT06512324
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 27 Jun 2024 to the primary completion date, 30 Aug 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Are considered unsuitable for outpatient care due to illness severity or other factors in the opinion of their prescribing physician,
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kind Health Group Coordinator of this site? Confirm its status | Encinitas | United States | Unknown status |
| Salience Research Institute Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.