Evidence map›Paper›PMID 40468342›Full record

Trial reportBMC medicine2025

Alleviating cognitive impairments in bipolar disorder with a novel DTI-guided multimodal neurostimulation protocol: a double-blind randomized controlled trial.

Minmin Wang, Hetong Zhou, Xiaomei Zhang, Qianfeng Chen, Qiqi Tong, Qiai Han, Xudong Zhao, Dandan Wang, Jianbo Lai, Hongjian He and 2 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05964777 (Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05964777 nacompletednot on this map

Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study

TypeinterventionalSponsorFirst Affiliated Hospital of Zhejiang UniversityRan2023 to 2024Enrolled116ConditionsBipolar Disorder in RemissionArmsrTMS(repeated transcranial magnetic stimulation), tACS(transcranial alternating current stimulation)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
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

12 authors.

Minmin Wang *Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Hetong Zhou *Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xiaomei Zhang *Department of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Qianfeng ChenDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Qiqi TongResearch Center for Data Hub and Security, Zhejiang Lab, Hangzhou, China.
Qiai HanDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Xudong ZhaoDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Dandan WangDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Jianbo LaiDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Hongjian HeSchool of Physics, Zhejiang University, Hangzhou, China. hhezju@zju.edu.cn.
Shaomin ZhangQiushi Academy for Advanced Studies, The State Key Lab of Brain-Machine Intelligence, Zhejiang University, Hangzhou, China. shaomin@zju.edu.cn.
Shaohua HuDepartment of Psychiatry, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. dorhushaohua@zju.edu.cn.

Funding

Chinese Medical Education Association 2022KTZ004Fundamental Research Funds for the Central Universities 226-2022-00193, 226-2022-00002, 2023ZFJH01-01, 2024ZFJH01-01Innovation team for precision diagnosis and treatment of major brain diseases 2020R01001Leading Talent of Scientific and Technological Innovation-"Ten Thousand Talents Program" of Zhejiang Province 2021R52016National Key Research and Development Program of China 2023YFC2506200National Natural Science Foundation of China 52407261, 82201675Research Project of Jinan Microecological Biomedicine Shandong Laboratory No. JNL-2023001B
6 · The paper itself

Abstract

backgroundTraditional neuromodulation strategies show promise in enhancing cognitive abilities in bipolar disorder (BD) but remain suboptimal. This study introduces a novel multimodal neurostimulation (MNS) protocol to improve therapeutic outcomes.

methodsThe novel MNS protocol used individualized diffusion tensor imaging (DTI) data to identify fiber tracts between the dorsolateral prefrontal cortex and dorsal anterior cingulate cortex. The highest structural connectivity point is selected as the individualized stimulation site, which is then targeted using a combination of optimized transcranial alternating current stimulation (tACS) and robot-assisted navigated repetitive transcranial magnetic stimulation (rTMS). A double-blind randomized controlled trial was conducted to investigate the clinical efficacy of this innovative neuromodulation approach on cognitive abilities in stable-phase BD patients. One hundred BD patients were randomly assigned to four groups: group A (active tACS-active rTMS (MNS protocol)), group B (sham tACS-active rTMS), group C (active tACS-sham rTMS), and group D (sham tACS-sham rTMS). Participants underwent 15 sessions over 3 weeks. Cognitive assessments (THINC integrated tool) were conducted at baseline (week 0) and post-treatment (week 3).

resultsSixty-six participants completed all 15 sessions. Group A (MNS protocol) showed superior improvements in Spotter CRT, TMT, and DSST scores compared to other groups at week 3. Only group A exhibited significant activation in the left frontal region post-MNS intervention. The novel MNS protocol was well tolerated, with no significant side effects observed.

conclusionsThe study indicates that DTI-guided multimodal neurostimulation mode significantly improves cognitive impairments and is safe for stable-phase BD patients.

trial registrationClinicalTrials.gov identifier: NCT05964777.

Indexed as

Bipolar DisorderCognitive DysfunctionDiffusion Tensor ImagingTranscranial Direct Current StimulationTranscranial Magnetic StimulationAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeDiffusion tensor imagingElectric fieldIndividualizationRepetitive transcranial magnetic stimulationTranscranial alternating current stimulation

Identifiers

PMID40468342
PMCPMC12139339

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Registered trials

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.