Evidence map›Paper›PMID 39152467›Full record

ArticleTrials2024

Efficacy of personalized repetitive transcranial magnetic stimulation based on functional reserve to enhance ambulatory function in patients with Parkinson's disease: study protocol for a randomized controlled trial.

Seo Jung Yun, Ho Seok Lee, Dae Hyun Kim, Sun Im, Yeun Jie Yoo, Na Young Kim, Jungsoo Lee, Donghyeon Kim, Hae-Yeon Park, Mi-Jeong Yoon and 3 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06350617 (Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease), which is not on this 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.

NCT06350617 narecruitingnot on this map

Safety and Efficacy of Personalized Repetitive Transcranial Magnetic Stimulation Protocol Based on Functional Reserve to Enhance Ambulatory Function in Patients With Parkinson Disease

TypeinterventionalSponsorSamsung Medical CenterRan2024 to 2026Enrolled60ConditionsParkinson's Disease and ParkinsonismArmsHigh-Frequency, ipsilateral M1, High-Frequency, bilateral M1, High-Frequency, Lt. DLPFC
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

13 authors.

Seo Jung YunDepartment of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Ho Seok LeeDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Dae Hyun KimDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Sun ImDepartment of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Yeun Jie YooDepartment of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Na Young KimDepartment of Rehabilitation Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea.
Jungsoo LeeDepartment of Medical IT Convergence Engineering, Kumoh National Institute of Technology, Gumi, Republic of Korea.
Donghyeon KimResearch Institute, NEUROPHET Inc, Seoul, Republic of Korea.
Hae-Yeon ParkDepartment of Rehabilitation Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Mi-Jeong YoonDepartment of Rehabilitation Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Young Seok KimDepartment of Rehabilitation Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea.
Won Hyuk ChangDepartment of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. wh.chang@samsung.com.
Han Gil SeoDepartment of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Republic of Korea. hangilseo@snu.ac.kr.ORCID http://orcid.org/0000-0001-6904-7542

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRepetitive transcranial magnetic stimulation (rTMS) is one of the non-invasive brain stimulations that modulate cortical excitability through magnetic pulses. However, the effects of rTMS on Parkinson's disease (PD) have yielded mixed results, influenced by factors including various rTMS stimulation parameters as well as the clinical characteristics of patients with PD. There is no clear evidence regarding which patients should be applied with which parameters of rTMS. The study aims to investigate the efficacy and safety of personalized rTMS in patients with PD, focusing on individual functional reserves to improve ambulatory function.

methodsThis is a prospective, exploratory, multi-center, single-blind, parallel-group, randomized controlled trial. Sixty patients with PD will be recruited for this study. This study comprises two sub-studies, each structured as a two-arm trial. Participants are classified into sub-studies based on their functional reserves for ambulatory function, into either the motor or cognitive priority group. The Timed-Up and Go (TUG) test is employed under both single and cognitive dual-task conditions (serial 3 subtraction). The motor dual-task effect, using stride length, and the cognitive dual-task effect, using the correct response rate of subtraction, are calculated. In the motor priority group, high-frequency rTMS targets the primary motor cortex of the lower limb, whereas the cognitive priority group receives rTMS over the left dorsolateral prefrontal cortex. The active comparator for each sub-study is bilateral rTMS of the primary motor cortex of the upper limb. Over 4 weeks, the participants will undergo 10 rTMS sessions, with evaluations conducted pre-intervention, mid-intervention, immediately post-intervention, and at 2-month follow-up. The primary outcome is a change in TUG time between the pre- and immediate post-intervention evaluations. The secondary outcome variables are the TUG under cognitive dual-task conditions, Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III, New Freezing of Gait Questionnaire, Digit Span, trail-making test, transcranial magnetic stimulation-induced motor-evoked potentials, diffusion tensor imaging, and resting state functional magnetic resonance imaging. DISCUSSION: The study will reveal the effect of personalized rTMS based on functional reserve compared to the conventional rTMS approach in PD. Furthermore, the findings of this study may provide empirical evidence for an rTMS protocol tailored to individual functional reserves to enhance ambulatory function in patients with PD.

trial registrationClinicalTrials.gov NCT06350617. Registered on 5 April 2024.

Indexed as

Parkinson DiseaseTranscranial Magnetic StimulationAgedCognitionFemaleHumansMaleMiddle AgedMotor CortexMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicRecovery of FunctionSingle-Blind MethodTime FactorsTreatment OutcomeFunctional reserveGaitParkinson’s diseaseRepetitive transcranial magnetic stimulation

Identifiers

PMID39152467
PMCPMC11328369

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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.