Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Ampa One TMS System
  Transcranial Magnetic Stimulation

Первичные конечные точки

• 9-item Patient Health Questionnaire (PHQ-9) [or PHQ-9-A if appropriate] [Срок оценки: 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] [Срок оценки: Administered weekly from baseline up to 1 year from the end of treatment.]

Вторичные конечные точки (3)

• Hamilton Depression Rating Scale (HAM-D) [if administered] [Срок оценки: Administered weekly from baseline up to 1 year from the end of treatment.]
• Montgomery-Asberg Depression Rating Scale (MADRS) [if administered] [Срок оценки: Administered weekly from baseline up to 1 year from the end of treatment.]
• Hamilton Anxiety Rating Scale (HAM-A) [if administered] [Срок оценки: Administered weekly from baseline up to 1 year from the end of treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

США · 2 центра

• Kind Health Group — Encinitas
• Salience Research Institute — Plano

Публикации

• 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;3 PMID 37984281
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06512324 · BDNF-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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