Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

NCT06512324 | Enrolling By Invitation FDA Device

• 1 other identifier: BDNF-001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief 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. 1.Which factors have the greatest causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?
2. 2.Which factors have a minimal causal role in mediating the effectiveness of TMS in improving symptoms of depression (and/or anxiety)?

Conditions

Major Depressive Disorder; MDD; Generalized Anxiety Disorder; GAD; Depression; Anxiety

Keywords

Transcranial Magnetic Stimulation; TMS; Noninvasive Brain Stimulation; Accelerated Protocol; Stimulation Parameters; Patient Health Questionnaire; Behavioral Factors; Physiological Factors; Generalized Anxiety Disorder 7-item Scale; PHQ-9; PHQ9; GAD-7; GAD7; Longitudinal Observational Study; Registry; Patient Characteristics; Pharmacological Factors; United States of America; USA, US; Canada; Hamilton Depression Rating Scale; Montgomery-Asberg Depression Rating Scale; Hamilton Anxiety Rating Scale; Generalized Anxiety Disorder 10-item Scale for Adolescents; GAD-10-A, GAD-10A, GAD10, GAD10A; Patient Health Questionnaire for Adolescents; PHQ-9A, PHQ9A

Outcome Measures

Primary Outcomes (2)

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

  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]

  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 Outcomes (3)

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

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

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

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

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

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

Interventions

Ampa One TMS System DEVICE

Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomedical Discoveries and Neuroscientific Foundations LLC: lead

Study Sites (2)

Kind Health Group

Encinitas, California, 92024, United States

Location

Salience Research Institute

Plano, Texas, 75093, United States

Location

Related Publications (5)

• Leuchter MK, Citrenbaum C, Wilson AC, Tibbe TD, Jackson NJ, Krantz DE, Wilke SA, Corlier J, Strouse TB, Hoftman GD, Tadayonnejad R, Koek RJ, Slan AR, Ginder ND, Distler MG, Artin H, Lee JH, Adelekun AE, Leuchter AF. A comparison of self- and observer-rated scales for detecting clinical improvement during repetitive transcranial stimulation (rTMS) treatment of depression. Psychiatry Res. 2023 Dec;330:115608. doi: 10.1016/j.psychres.2023.115608. Epub 2023 Nov 14.

  PMID: 37984281 BACKGROUND

• Sackeim HA, Aaronson ST, Carpenter LL, Hutton TM, Mina M, Pages K, Verdoliva S, West WS. Clinical outcomes in a large registry of patients with major depressive disorder treated with Transcranial Magnetic Stimulation. J Affect Disord. 2020 Dec 1;277:65-74. doi: 10.1016/j.jad.2020.08.005. Epub 2020 Aug 7.

  PMID: 32799106 BACKGROUND

• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

  PMID: 29726344 BACKGROUND

• George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.

  PMID: 20439832 BACKGROUND

• O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007 Dec 1;62(11):1208-16. doi: 10.1016/j.biopsych.2007.01.018. Epub 2007 Jun 14.

  PMID: 17573044 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jonathan Downar, MD PhD FRCPC

  AMPA Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: June 27, 2024
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)