Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression
Publication: American Journal of Psychiatry
Abstract
Objective:
New antidepressant treatments are needed that are effective, rapid acting, safe, and tolerable. Intermittent theta-burst stimulation (iTBS) is a noninvasive brain stimulation treatment that has been approved by the U.S. Food and Drug Administration for treatment-resistant depression. Recent methodological advances suggest that the current iTBS protocol might be improved through 1) treating patients with multiple sessions per day at optimally spaced intervals, 2) applying a higher overall pulse dose of stimulation, and 3) precision targeting of the left dorsolateral prefrontal cortex (DLPFC) to subgenual anterior cingulate cortex (sgACC) circuit. The authors examined the feasibility, tolerability, and preliminary efficacy of Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), an accelerated, high-dose resting-state functional connectivity MRI (fcMRI)–guided iTBS protocol for treatment-resistant depression.
Methods:
Twenty-two participants with treatment-resistant depression received open-label SAINT. fcMRI was used to individually target the region of the left DLPFC most anticorrelated with sgACC in each participant. Fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) were delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold (adjusted for cortical depth). Neuropsychological testing was conducted before and after SAINT.
Results:
One participant withdrew, leaving a sample size of 21. Nineteen of 21 participants (90.5%) met remission criteria (defined as a score <11 on the Montgomery-Åsberg Depression Rating Scale). In the intent-to-treat analysis, 19 of 22 participants (86.4%) met remission criteria. Neuropsychological testing demonstrated no negative cognitive side effects.
Conclusions:
SAINT, an accelerated, high-dose, iTBS protocol with fcMRI-guided targeting, was well tolerated and safe. Double-blinded sham-controlled trials are needed to confirm the remission rate observed in this initial study.
Formats available
You can view the full content in the following formats:
Supplementary Material
File (appi.ajp.2019.19070720.ds001.pdf)
- Download
- 253.49 KB
Information & Authors
Information
Published In
History
Received: 23 July 2019
Revision received: 25 November 2019
Accepted: 2 January 2020
Published online: 7 April 2020
Published in print: August 01, 2020
Keywords
Authors
Competing Interests
Dr. Bentzley has served as a consultant for Owl Insights. Dr. DeBattista has received research support from Abbott, Biolite, Compass, Janssen, and Myriad and has served as a consultant or on advisory boards for Alkermes, Corcept, and Sage. Dr. Schatzberg has received research support from Janssen and has served as a consultant for Alkermes, Bracket, Epiodyne, Janssen, Jazz, Lundbeck/Takeda, McKinsey, Myriad, Neuronetics, and Sunovion; he holds equity in Corcept, Delpor, Dermira, Epiodyne, Gilead, Incyte Genetics, Intersect ENT, Madrigal, Merck, Owl Analytics, Seattle Genetics, Titan, and Xhale; and he is named as an inventor on Stanford University patents. Drs. Sudheimer and Williams have patents on the methodology discussed in this report. Dr. Williams has served on a scientific advisory board for Halo Neuroscience. The other authors report no financial relationships with commercial interests.
Funding Information
The Marshall and Dee Ann Payne Fund:
Neuromodulation Research Fund:
NIH: T32 035165, UL1 TR001085
Stanford CNI Innovation Award:
Stanford Psychiatry Chairman’s Small Grant:
Stanford Medical Scholars Research Scholarship:
Brain and Behavior Research Foundationhttp://dx.doi.org/10.13039/100000874: NARSAD Young Investigator Award
Department of Psychiatry and Behavioral Sciences at Stanford University:
Lehman Family:
Still Charitable Fund:
Avy L. and Robert L. Miller Foundation:
Gordie Brookstone Fund:
Charles R. Schwab:
Supported by Charles R. Schwab, the Gordie Brookstone Fund, the Marshall and Dee Ann Payne Fund, the Lehman Family, the Neuromodulation Research Fund, the Still Charitable Fund, the Avy L. and Robert L. Miller Foundation, a Stanford Psychiatry Chairman’s Small Grant, a Stanford CNI Innovation Award, NIH grants T32 035165 and UL1 TR001085, a Stanford Medical Scholars Research Scholarship, a NARSAD Young Investigator Award, and the Department of Psychiatry and Behavioral Sciences at Stanford University.Metrics & Citations
Metrics
Citations
Export Citations
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.
For more information or tips please see 'Downloading to a citation manager' in the Help menu.
There are no citations for this item
View Options
Get Access
Login options
Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.
Personal login Institutional Login Open Athens loginNot a subscriber?
PsychiatryOnline subscription options offer access to the DSM-5-TR® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.
Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).