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NCT06512324

Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Enrolling by Invitation
Not specifiedAges 12+Observational
Biomedical Discoveries and Neuroscientific Foundations LLC
~5,000 participants
Updated 2024-07-22 on ClinicalTrials.gov
What's tested:Ampa One TMS System

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]
Measured over Administered weekly from baseline up to 1 year from the end of treatment.
+1 more outcome measured

Conditions

Major Depressive Disorder
MDD
Generalized Anxiety Disorder
GAD
Depression
Anxiety

Explore related trials

Generalized Anxiety DisorderUnipolar Depression

Where it's being run

2 sites across 2 states
California1
Texas1

Study leadership

  • Jonathan Downar, MD PhD FRCPC · PRINCIPAL_INVESTIGATOR · Ampa Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate]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.

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