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NCT Number: NCT06512324

Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

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.

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Key information

Conditions

Major Depressive Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major GAD Generalized Anxiety Disorder MDD Mental Disorders Mood Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kind Health Group, Encinitas, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ampa One TMS System

Device

Transcranial Magnetic Stimulation

Primary outcomes

  1. 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.

    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.

  2. 7-item General Anxiety Disorder Questionnaire (GAD-7) [or GAD-10-A if appropriate]

    Time frame: Administered weekly from baseline up to 1 year from the end of treatment.

    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.

Secondary outcomes

  1. Hamilton Depression Rating Scale (HAM-D) [if administered]

    Time frame: Administered weekly from baseline up to 1 year from the end of treatment.

    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).

  2. Montgomery-Asberg Depression Rating Scale (MADRS) [if administered]

    Time frame: Administered weekly from baseline up to 1 year from the end of treatment.

    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)).

  3. Hamilton Anxiety Rating Scale (HAM-A) [if administered]

    Time frame: Administered weekly from baseline up to 1 year from the end of treatment.

    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.

Sponsors and collaborators

Lead sponsor

Biomedical Discoveries and Neuroscientific Foundations LLC

Industry

Registry information

Official study title

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

Acronym: OBSERVER

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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