Evidence map›Paper›PMID 41668204›Full record

ArticleTrials2026

Efficacy and safety of high-definition transcranial direct current stimulation combined with digital rehabilitation on upper limb function in stroke patients: study protocol for a randomized, double-blind, sham-controlled confirmatory trial.

Jinuk Kim, Su-Hyun Lee, Eunmi Kim, Seung-Rok Kang, Yun-Ju Jo, Ji-Eon Yun, Seung Hyun Lee, Ho Choon Jeong, Myoung-Hwan Ko, Yun-Hee Kim

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

10 authors.

Jinuk Kim *Department of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Suwon, 16419, Republic of Korea.
Su-Hyun Lee *Department of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Suwon, 16419, Republic of Korea.
Eunmi KimDepartment of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Suwon, 16419, Republic of Korea.
Seung-Rok KangBiomedical Research Institute, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea.
Yun-Ju JoBiomedical Research Institute, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea.
Ji-Eon YunBiomedical Research Institute, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea.
Seung Hyun LeeGlobal Health Technology Research Center, College of Health Science, Korea University, Seoul, 02841, Republic of Korea.
Ho Choon JeongCyberMedic Co., Ltd., Gwangju, 61008, Republic of Korea.
Myoung-Hwan Ko *Biomedical Research Institute, Jeonbuk National University Hospital, Jeonju, 54907, Republic of Korea. mhko@jbnu.ac.kr.
Yun-Hee Kim *Department of Physical and Rehabilitation Medicine, Sungkyunkwan University School of Medicine, Suwon, 16419, Republic of Korea. yunkim@skku.edu.ORCID http://orcid.org/0000-0001-6101-8851

Funding

Korea Medical Device Development Fund KMDF‑RS‑2022-00140478
6 · The paper itself

Abstract

backgroundStroke remains a leading cause of long-term disability worldwide, with a significant proportion of survivors suffering from persistent upper limb impairments despite conventional rehabilitation. High-definition transcranial direct current stimulation (HD-tDCS) has emerged as a promising neuromodulation technique capable of precise cortical targeting, potentially enhancing motor recovery when combined with structured rehabilitation. This study aims to confirm the efficacy and safety of HD-tDCS combined with digital upper limb rehabilitation in improving upper limb motor function among stroke survivors.

methodsThis multicenter, randomized, parallel-group, double-blind, sham-controlled superiority trial will enroll 64 participants with chronic unilateral stroke who will be randomized to receive either active HD-tDCS or sham stimulation, both combined with standardized digital upper limb rehabilitation. The intervention will consist of 10 sessions over 4 weeks (40 min per session). Each session will include 10 min of HD-tDCS at rest targeting the ipsilesional primary motor cortex and anterior intraparietal sulcus, followed by 20 min of task-based digital rehabilitation with concurrent HD-tDCS, and a final 10 min of digital rehabilitation alone. The primary outcome will be the postintervention change in the Fugl-Meyer Assessment of Upper Extremity score from baseline. Secondary outcomes will include grip and pinch strength, 9-Hole Pegboard Test, Box and Block Test, finger-tapping performance, Short Form-36, and cortical activation measured via integrated functional near-infrared spectroscopy (fNIRS). fNIRS will help characterize task-related cortical hemodynamic responses in the stimulated area, which are associated with motor recovery. DISCUSSION: This trial provides promising exploratory findings and is designed to rigorously assess both behavioral and hemodynamic brain responses. By integrating real-time brain monitoring, this study seeks to contribute to existing evidence on the mechanisms underlying HD-tDCS-enhanced neuroplasticity and inform the development of future precision neurorehabilitation strategies.

trial registrationThis trial has been registered at the Clinical Research Information Service (Registration number: KCT0010556). Registration date: May 28, 2025.

Indexed as

StrokeStroke RehabilitationTranscranial Direct Current StimulationUpper ExtremityAdultAgedCombined Modality TherapyDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleMiddle AgedMotor CortexMulticenter Studies as TopicRandomized Controlled Trials as TopicDigital rehabilitationFunctional near-infrared spectroscopyHigh-definition transcranial direct current stimulationMotor recoveryNeuroplasticityRandomized controlled trialStroke rehabilitation

Identifiers

PMID41668204
PMCPMC12903231

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LicenceCC BY-NC-ND
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Registered trials

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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.