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

July 16, 2024 updated by: Biomedical Discoveries and Neuroscientific Foundations LLC

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Kind Health Group
    • Texas
      • Plano, Texas, United States, 75093
        • Salience Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include male, female, and nonbinary patients who are experiencing symptoms of depression and/or anxiety and who have elected to undergo TMS treatment at a participating TMS treatment site, after having been deemed suitable for treatment by their prescribing physician. Participants will have voluntarily chosen to undergo a clinical course of TMS treatment at participating between June 27, 2024, to December 31, 2029. Eligible individuals must be 12 years or older, and participation is limited to those who understand English due to the availability of an English-only informed consent form (ICF).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Administered weekly from baseline up to 1 year from the end of treatment.
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.
Administered weekly from baseline up to 1 year from the end of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Administered weekly from baseline up to 1 year from the end of treatment.
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)).
Administered weekly from baseline up to 1 year from the end of treatment.
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.
Administered weekly from baseline up to 1 year from the end of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomedical Discoveries and Neuroscientific Foundations LLC

Investigators

  • Principal Investigator: Jonathan Downar, MD PhD FRCPC, Ampa Health Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2024

Primary Completion (Estimated)

August 30, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BDNF-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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