Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Part of paid clinical trials in Encinitas, California.

Sponsor
Biomedical Discoveries and Neuroscientific Foundations LLC
Study ID
NCT06512324
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ampa One TMS System — DEVICE
    Transcranial Magnetic Stimulation

Study Details

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.

Key Dates

Start date
Jun 27, 2024
Status verified
Jul 2024
Primary completion
Aug 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
5,000 participants (estimated)

Primary Outcome Measure

9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate] [ Time Frame: Administered weekly from baseline up to 1 year from the end of treatment. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Kind Health GroupEncinitasCalifornia92024-
Salience Research InstitutePlanoTexas75093-

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