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Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

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

NCT06512324•Biomedical Discoveries and Neuroscientific Foundations LLC

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.

Eligibility

Age

12 - No limit years

Sex

ALL

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.

Locations (2)

Kind Health Group

Encinitas, California, United States

Salience Research Institute

Plano, Texas, United States

Key Dates

Start Date

June 27, 2024

Primary Completion Date

August 30, 2028

Completion Date

December 31, 2029

Last Updated

July 22, 2024

Enrollment

5,000

ESTIMATED participants

Conditions

Major Depressive DisorderMDDGeneralized Anxiety DisorderGADDepressionAnxiety

Interventions

Ampa One TMS System

DEVICE

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

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