Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Last updated: July 16, 2024
Sponsor: Biomedical Discoveries and Neuroscientific Foundations LLC
Overall Status: Active - Enrolling

Phase

N/A

Condition

Depression

Depression (Major/severe)

Anxiety Disorders

Treatment

Ampa One TMS System

Clinical Study ID

NCT06512324
BDNF-001
  • Ages > 12
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Have a primary diagnosis of major depressive disorder (MDD) and/or generalizedanxiety 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 TMStreatment in terms of safety and presenting indication,

  • Have consented to undergo a therapeutic course of TMS treatment at one of theparticipating clinic sites,

  • Are able to communicate in the English language.

Exclusion

Exclusion Criteria:

  • Have been found to have any contraindication to TMS treatment by their prescribingphysician,

  • Are considered unsuitable for outpatient care due to illness severity or otherfactors 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 schedulefor primary outcome measures,

  • Lack the ability to communicate in the English language.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Ampa One TMS System
Phase:
Study Start date:
June 27, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Kind Health Group

    Encinitas, California 92024
    United States

    Site Not Available

  • Salience Research Institute

    Plano, Texas 75093
    United States

    Site Not Available

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