Evidence map›Paper›PMID 42518963›Full record

ArticleTranscranial magnetic stimulation (2024)2025

A double-blind, randomized, sham-controlled clinical trial of cerebellar intermittent theta burst stimulation for bipolar disorder: Safety, tolerability, mood and cognitive effects.

Nicholas T Trapp, Victoria A Muller Ewald, Benjamin D Pace, Linder Wendt, Laren Garrett, Brandan Penaluna, Jacob Miller, Anthony Purgianto, Ellen van der Plas, Vincent A Magnotta and 3 more

Abstract read
In one paragraph

Article in Transcranial magnetic stimulation (2024), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Nicholas T TrappDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Victoria A Muller EwaldDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Benjamin D PaceDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Linder WendtInstitute for Clinical and Translational Science, University of Iowa, Iowa City, IA, United States.
Laren GarrettDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Brandan PenalunaDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Jacob MillerDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Anthony PurgiantoDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Ellen van der PlasDepartment of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR, United States.
Vincent A MagnottaDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
John A WemmieDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Krystal L ParkerDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.
Aaron D BoesDepartment of Psychiatry, University of Iowa, Iowa City, IA, United States.

Funding

Child Neurologist Career Development Program (CNCDP)K12NS098482 · NINDS · HUGO W. MOSER RES INST KENNEDY KRIEGER · PI SCHLAGGAR, BRADLEY L · 2016 to 2025
$26.2M
The University of Iowa Clinical and Translational Science AwardUL1TR002537 · NCATS · UNIVERSITY OF IOWA · PI HANSEN, MARLAN R, WINOKUR, PATRICIA · 2018 to 2022
$20.0M
University of Iowa Institute for Clinical and Translational ScienceUM1TR004403 · NCATS · UNIVERSITY OF IOWA · PI Marlan R Hansen, Patricia Winokur · 2023 to 2026
$16.1M
University of Iowam - Whole Body 7T MRI ScannerS10RR028821 · NCRR · UNIVERSITY OF IOWA · PI MAGNOTTA, VINCENT A · 2010 to 2010
$8.0M
Cerebellar metabolism, neural circuits, and symptoms in bipolar disorderR01MH111578 · NIMH · UNIVERSITY OF IOWA · PI VINCENT A MAGNOTTA, John A Wemmie · 2017 to 2026
$5.7M
The Iowa Neuroscience Specialty Program in Research Education (INSPIRE)T32MH019113 · NIMH · UNIVERSITY OF IOWA · PI HANNA E STEVENS, John A Wemmie · 1991 to 2026
$5.6M
Cerebellar circuits, timing, and cognitionR01MH118240 · NIMH · UNIVERSITY OF IOWA · PI PARKER, KRYSTAL LYNN · 2019 to 2023
$2.2M
Predicting Cognitive Outcomes from Stroke Based on Lesion LocationR01NS114405 · NINDS · UNIVERSITY OF IOWA · PI BOES, AARON D · 2020 to 2024
$2.1M
Mechanisms of Health and Disease at the Behavioral-Biomedical InterfaceT32GM108540 · NIGMS · UNIVERSITY OF IOWA · PI LUTGENDORF, SUSAN K, VOSS, MICHELLE WEBB · 2014 to 2023
$1.7M
Investigating Network Plasticity Effects of Repetitive Brain Stimulation Following Invasive and Noninvasive Methods in HumansK23MH125145 · NIMH · UNIVERSITY OF IOWA · PI TRAPP, NICHOLAS THOMAS · 2021 to 2025
$934k
The therapeutic potential of the cerebellum in schizophreniaK01MH106824 · NIMH · UNIVERSITY OF IOWA · PI PARKER, KRYSTAL LYNN · 2015 to 2019
$820k
NCATS NIH HHS UL1 TR002537NCATS NIH HHS UM1 TR004403NCRR NIH HHS S10 RR028821NIGMS NIH HHS T32 GM108540NIMH NIH HHS K01 MH106824NIMH NIH HHS K23 MH125145NIMH NIH HHS R01 MH111578NIMH NIH HHS R01 MH118240NIMH NIH HHS T32 MH019113NINDS NIH HHS K12 NS098482NINDS NIH HHS R01 NS114405
6 · The paper itself

Abstract

Intermittent theta burst stimulation (iTBS) applied to the midline cerebellum has effects on mood and cognition in patients with neuropsychiatric disease. In bipolar disorder, depressive and cognitive symptoms are often inadequately treated with current therapeutic options. This randomized, double-blind, sham-controlled clinical trial evaluated the safety, tolerability, and efficacy of applying 10 sessions of iTBS, delivered twice daily, targeting cerebellar vermis (CBM-iTBS) in subjects with bipolar disorder. Primary outcome measures were change in depression using the Montgomery-Åsberg Depression Rating Scale and change in cognition using the NIH Toolbox Cognitive Battery from baseline to post-treatment (primary endpoint), and 1-, 3-, and 8-week follow-ups. Significant improvements in depression in sham (n = 18, mean age 37.8, 83 % female) and active (n = 12, mean age 41.9, 83 % female) treatment arms were observed post-treatment (active and sham, p = 0.02 and 0.001, respectively). Additionally, 1-week (sham), 3-week (sham), and 8-week (active) follow-ups all showed significant depression improvement (all p < 0.05), with no statistical separation between groups in the depressed cohort. Importantly, CBM-iTBS was well-tolerated, with the only affective switching to mania or mixed state occurring during follow-up in one active and one sham participant. The active group outperformed sham on measures of life satisfaction, meaning, self-efficacy, and reduced anger at varied time-points, with broad mood improvements in both groups. Cognitive performance improved in both treatment arms, with greater cognitive improvements in picture sequence memory testing and reaction time for the active group. In conclusion, CBM-iTBS is safe, feasible, and tolerable in individuals with bipolar disorder. Significant improvements with both active and sham iTBS on mood and cognitive measures suggest prominent placebo and learning effects. Future CBM-iTBS trials should consider modifications to treatment dose, coil design, and cerebellar target region.

Indexed as

Bipolar disorderCerebellumDepressionIntermittent theta burst stimulationITBSNeuronavigationPlaceboTargetingTMSTranscranial magnetic stimulation

Identifiers

PMID42518963
PMCPMC13384228

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.