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Cerebellar iTBS for Bipolar Disorder: A Randomized, Controlled Trial of Safety, Feasibility, and Preliminary Effects on Mood and Cognition
Abstract   Open access   Peer reviewed

Cerebellar iTBS for Bipolar Disorder: A Randomized, Controlled Trial of Safety, Feasibility, and Preliminary Effects on Mood and Cognition

Nicholas Trapp, Benjamin Pace, Brandan Penaluna, Victoria Muller Ewald, Linder Wendt, Jacob Miller, Anthony Purgianto, Ellen van der Plas, Krystal Parker and Aaron Boes
Brain stimulation, Vol.16(1), p.233
01/01/2023
DOI: 10.1016/j.brs.2023.01.350
url
https://doi.org/10.1016/j.brs.2023.01.350View
Published (Version of record) Open Access

Abstract

Background: Cerebellar connections to the prefrontal cortex are implicated in mood regulation and cognitive function. Preliminary data exists suggesting that intermittent theta burst (iTBS) stimulation applied to the midline cerebellum can affect mood and cognition in patients with psychiatric disorders, but these effects have not been characterized in subjects with bipolar disorder. Objective: Evaluate the safety, feasibility, and efficacy of applying iTBS to the midline cerebellum in subjects with bipolar disorder. Methods: Patients with bipolar disorder were recruited for a randomized, double-blind, sham-controlled clinical trial of 10 sessions of iTBS (two per day) targeting the cerebellar vermis. Primary outcome was change on the Montgomery Asberg Depression Rating Scale. Secondary outcome measures focused on safety, feasibility, affective and cognitive functioning. Follow up occurred immediately post-treatment and at 1, 3, and 8 weeks. Results: Per-protocol analysis revealed significant improvements in depression severity in the sham and active treatment arms immediately post-treatment in the full cohort (n=30, p=0.001 and p=0.006, respectively) and in the depressed subsample receiving sham but not active (n=21, p<0.001 and p=0.09, respectively). Sham response remained significant at 1 week and 3 week follow-up time points. Active response reached significance at the 8 week follow-up. Improvement was noted in other emotional and cognitive measures. No group by time interaction effects survived multiple comparisons correction. Conclusions: iTBS of the midline cerebellum is safe, feasible, and tolerable in subjects with bipolar disorder. Both sham and active cerebellar iTBS result in significant improvements in mood and cognition, suggesting large placebo and learning effects.

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