Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study

Samuel Bulteau; Lysianne Beynel; Christian Marendaz; Gaelle Dall'Igna; Morgane Peré; Sylvain Harquel; Alan Chauvin; Nathalie Guyader; Anne Sauvaget; Jean-Marie Vanelle; Mircea Polosan; Thierry Bougerol; Jerôme Brunelin; David Szekely

doi:10.1016/j.neucli.2019.10.002

Twice-daily neuronavigated intermittent theta burst stimulation for bipolar depression: A Randomized Sham-Controlled Pilot Study

Neurophysiol Clin. 2019 Nov;49(5):371-375. doi: 10.1016/j.neucli.2019.10.002. Epub 2019 Nov 21.

Authors

Affiliations

¹ Clinical Investigation Unit "Behavioral Addictions/Complex Affective Disorders", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France; Inserm U1246, MethodS in Patients-centered outcomes and HEalth Research, University of Nantes, 44000 Nantes, France. Electronic address: samuel.bulteau@chu-nantes.fr.
² CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France; Department of Psychiatry and Behavioral Science, Duke University School of Medicine, 200, Trent Drive, Box 3620 DUMC, NC 27710 Durham, USA.
³ CNRS, UMR5105, Laboratory of Psychology and Neurocognition, Grenoble Alpes University, 38000 Grenoble, France.
⁴ Department of Psychiatry and Neurology, CHU de Grenoble, 38000 Grenoble, France.
⁵ Biostatistic department, CHU de Nantes, 44000 Nantes, France.
⁶ CNRS UMR5216, Grenoble Images Speech Signal and Control, Grenoble Alpes University, 38000 Grenoble, France.
⁷ Clinical Investigation Unit "Behavioral Addictions/Complex Affective Disorders", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France; Laboratory "Movement, Interactions, Performance" (EA 4334), Faculty of Sport Sciences, University of Nantes, Nantes, France.
⁸ Clinical Investigation Unit "Behavioral Addictions/Complex Affective Disorders", Addictology and Psychiatry Department, CHU de Nantes, 44000 Nantes, France.
⁹ Inserm U1028, CNRS UMR5292, Lyon Neuroscience Research Center, PSYR2 Team, University Lyon, 69000 Lyon, France; University Lyon 1, 69000 Villeurbanne, France; Centre hospitalier Le Vinatier, 69678 Bron, France.
¹⁰ Department of psychiatry, centre hospitalier Princesse-Grace, 98000 Monaco.

PMID: 31761447
DOI: 10.1016/j.neucli.2019.10.002

Abstract

The safety and efficacy of neuronavigated intermittent theta burst stimulation (iTBS) in patients with bipolar depression has not yet been investigated. We hypothesized the superiority of active iTBS over sham. Twenty-six patients were randomly allocated to receive either active (n=12) or sham (n=14) iTBS. Response and remission rates according to changes in depression MADRS score were high following active iTBS (72% and 42% for response and remission rates, respectively), but no significant difference was found after sham stimulation (42%and 25%). No adverse events were observed. This study revealed the safety and tolerability of twice daily iTBS in patients with bipolar depression. Larger controlled studies are warranted to prove iTBS superiority in treatment-resistant bipolar depression.

Keywords: Bipolar depression; Dorsolateral prefrontal cortex; Neuronavigation; Randomized pilot trial; Repetitive transcranial magnetic stimulation; Resistant depression; Theta burst stimulation.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Bipolar Disorder / physiopathology*
Depressive Disorder, Major / physiopathology*
Depressive Disorder, Treatment-Resistant / physiopathology*
Female
Humans
Male
Pilot Projects
Prefrontal Cortex / physiology
Transcranial Magnetic Stimulation / methods
Treatment Outcome
Young Adult