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Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial.
Demchenko, Ilya; Rampersad, Sumientra; Datta, Abhishek; Horn, Andreas; Churchill, Nathan W; Kennedy, Sidney H; Krishnan, Sridhar; Rueda, Alice; Schweizer, Tom A; Griffiths, John D; Boyden, Edward S; Santarnecchi, Emiliano; Bhat, Venkat.
Afiliación
  • Demchenko I; Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto, Toronto, ON, Canada.
  • Rampersad S; Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
  • Datta A; Institute for Biomedical Engineering, Science and Technology (iBEST), Keenan Research Centre for Biomedical Science, St. Michael's Hospital - Unity Health Toronto, Toronto, ON, Canada.
  • Horn A; Department of Physics, University of Massachusetts Boston, Boston, MA, United States.
  • Churchill NW; Department of Electrical and Computer Engineering, Northeastern University, Boston, MA, United States.
  • Kennedy SH; Research and Development, Soterix Medical, Inc., Woodbridge, NJ, United States.
  • Krishnan S; Department of Biomedical Engineering, City College of New York, New York, NY, United States.
  • Rueda A; Department of Neurology, Center for Brain Circuit Therapeutics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States.
  • Schweizer TA; Department of Neurosurgery & Center for NeuroTechnology and NeuroRecovery (CNTR), Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.
  • Griffiths JD; Movement Disorder and Neuromodulation Unit, Department of Neurology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt - Universität zu Berlin, Berlin, Germany.
  • Boyden ES; Keenan Research Centre for Biomedical Science, St. Michael's Hospital - Unity Health Toronto, Toronto, ON, Canada.
  • Santarnecchi E; Neuroscience Research Program, St. Michael's Hospital - Unity Health Toronto, Toronto, ON, Canada.
  • Bhat V; Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Front Neurosci ; 18: 1390250, 2024.
Article en En | MEDLINE | ID: mdl-39268031
ABSTRACT

Background:

Transcranial temporal interference stimulation (tTIS) is a new, emerging neurostimulation technology that utilizes two or more electric fields at specific frequencies to modulate the oscillations of neurons at a desired spatial location in the brain. The physics of tTIS offers the advantage of modulating deep brain structures in a non-invasive fashion and with minimal stimulation of the overlying cortex outside of a selected target. As such, tTIS can be effectively employed in the context of therapeutics for the psychiatric disease of disrupted brain connectivity, such as major depressive disorder (MDD). The subgenual anterior cingulate cortex (sgACC), a key brain center that regulates human emotions and influences negative emotional states, is a plausible target for tTIS in MDD based on reports of its successful neuromodulation with invasive deep brain stimulation.

Methods:

This pilot, single-site, double-blind, randomized, sham-controlled interventional clinical trial will be conducted at St. Michael's Hospital - Unity Health Toronto in Toronto, ON, Canada. The primary objective is to demonstrate target engagement of the sgACC with 130 Hz tTIS using resting-state magnetic resonance imaging (MRI) techniques. The secondary objective is to estimate the therapeutic potential of tTIS for MDD by evaluating the change in clinical characteristics of participants and electrophysiological outcomes and providing feasibility and tolerability estimates for a large-scale efficacy trial. Thirty participants (18-65 years) with unipolar, non-psychotic MDD will be recruited and randomized to receive 10 sessions of 130 Hz tTIS or sham stimulation (n = 15 per arm). The trial includes a pre- vs. post-treatment 3T MRI scan of the brain, clinical evaluation, and electroencephalography (EEG) acquisition at rest and during the auditory mismatch negativity (MMN) paradigm.

Discussion:

This study is one of the first-ever clinical trials among patients with psychiatric disorders examining the therapeutic potential of repetitive tTIS and its neurobiological mechanisms. Data obtained from this trial will be used to optimize the tTIS approach and design a large-scale efficacy trial. Research in this area has the potential to provide a novel treatment option for individuals with MDD and circuitry-related disorders and may contribute to the process of obtaining regulatory approval for therapeutic applications of tTIS. Clinical Trial Registration ClinicalTrials.gov, identifier NCT05295888.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Front Neurosci Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Front Neurosci Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Suiza