Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
NCT Number: NCT06512324
Acronym: OBSERVER
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Major Depressive Disorder|MDD|Generalized Anxiety Disorder|GAD|Depression|Anxiety
Interventions: DEVICE: Ampa One TMS System
Sponsor: Biomedical Discoveries and Neuroscientific Foundations LLC
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 5000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-27
Completion Date: 2029-12-31
Locations: Kind Health Group, Encinitas, California, 92024, United States|Salience Research Institute, Plano, Texas, 75093, United States

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.

Primary Outcome Measures: 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate], The PHQ-9 gauges depressive symptoms through its 9-item brief inventory, efficiently quantifying a spectrum of symptoms, including mood, energy, concentration, sleep, appetite, and suicidality. Widely adopted in outpatient care due to its reliability and validity, the PHQ-9 is a well-established tool in TMS practice, and has shown greater likelihood to detect improvement and less likelihood to miss response or remission among patients undergoing TMS treatment (Leuchter et al. 2023). The PHQ-9-A is the adolescent version of the PHQ-9., Administered weekly from baseline up to 1 year from the end of treatment.|7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate], The GAD-7, a concise self-report questionnaire evaluating the severity of Generalized Anxiety Disorder (GAD) symptoms, is comprised of seven items. Respondents rate the frequency of experiences over the past two weeks on a Likert scale, resulting in a total score ranging from 0 to 21. The GAD-7 is a streamlined and effective measure, capturing core symptoms such as excessive worrying, restlessness, irritability, muscle tension, and sleep disturbances. It is likewise widely used in real-world TMS practices and registries of TMS outcomes (Sackeim et al. 2020). The GAD-10-A is the adolescent version of the GAD-7., Administered weekly from baseline up to 1 year from the end of treatment.
Secondary Outcome Measures: Hamilton Depression Rating Scale (HAM-D) [if administered], A clinician-administered 17-item scale assessing neurovegetative, mood and hedonic, cognitive, and other symptom domains, widely used in major studies of TMS in depression (Blumberger et al. 2018)., Administered weekly from baseline up to 1 year from the end of treatment.|Montgomery-Asberg Depression Rating Scale (MADRS) [if administered], A 10-item clinician-rated scale assessing emotional, cognitive, and psychomotor aspects of depression, also widely used in TMS research studies (e.g., (O'Reardon et al. 2007; George et al. 2010))., Administered weekly from baseline up to 1 year from the end of treatment.|Hamilton Anxiety Rating Scale (HAM-A) [if administered], A clinician-administered 14-item scale psychological questionnaire used to assess the severity of a person's anxiety; it measures both psychic anxiety and somatic anxiety., Administered weekly from baseline up to 1 year from the end of treatment.