Evidence map›Paper›PMID 38650028›Full record

ArticleTrials2024

Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson's disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial.

Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao and 2 more

Open access · goldAbstract 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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 16% of its field
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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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 at 1 institution in 1 country.

Chuanyu Zhong *Department of Ultrasound in Medicine, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Ning Guo *Department of Ultrasound in Medicine, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Canfang Hu *Department of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Ruilong NiDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Xiaojie ZhangDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Zheying MengDepartment of Ultrasound in Medicine, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Taotao LiuDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Siqi DingDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Wanhai DingDepartment of Neurosurgery, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China.
Yuwu ZhaoDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China. zhaoyuwu2005@126.com.
Li CaoDepartment of Neurology, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China. caoli2000@yeah.net.
Yuanyi ZhengDepartment of Ultrasound in Medicine, Shanghai Jiao Tong University of Medicine Affiliated Sixth People's Hospital, Shanghai, 200233, People's Republic of China. zhengyuanyi@sjtu.edu.cn.
Shanghai Jiao Tong University · CN

Funding

Key Project of the National Natural Science Foundation of China No. 82030050Medical Innovations Research Special Key Project of Shanghai 'Science and Technology Innovation Action Plan' 21Y21901100
6 · The paper itself

Abstract

backgroundParkinson's disease (PD) is a progressive, neurodegenerative illness marked by the loss of dopaminergic neurons, causing motor symptoms. Oral levodopa replacement therapy remains the gold standard in the treatment of PD. It is, nevertheless, a symptomatic treatment. There is currently no effective treatment for PD. Therefore, new therapies for PD are highly desirable. Low-intensity pulsed ultrasound (LIPUS) has been shown to improve behavioral functions in PD animal models. It is a new type of neuromodulation approach that combines noninvasiveness with high spatial precision. The purpose of this study is to establish a new clinical protocol for LIPUS in the treatment of movement disorders in patients with PD.

methodsThis protocol is a single-site, prospective, double-blind, randomized controlled trial (RCT). Forty-eight participants with clinically confirmed PD will be randomly allocated to one of two groups: LIPUS group or sham group. All of the participants continue to use pharmacological therapy as a fundamental treatment. The primary outcome is the difference between groups from baseline to 4 months in the change in the Unified Parkinson's Disease Rating Scale (UPDRS) motor score (part III). The secondary outcomes include the rating scales such as the Mini-Mental State Examination (MMSE), and other three rating scales, and medical examinations including high-density electroencephalography (hdEEG) and functional magnetic resonance imaging (fMRI). The primary safety outcome will be assessed at 4 months, and adverse events will be recorded. DISCUSSION: This study represents the clinical investigation into the efficacy of therapeutic LIPUS in the treatment of PD for the first time. If LIPUS is determined to be effective, it could offer a practical and innovative means of expanding the accessibility of ultrasound therapy by using a wearable LIPUS device within a home setting.

trial registrationChinese Clinical Trial Registry ChiCTR2100052093. Registered on 17 October 2021.

Indexed as

Parkinson DiseaseRandomized Controlled Trials as TopicUltrasonic TherapyAgedChinaDouble-Blind MethodFemaleHumansMaleMiddle AgedProspective StudiesTime FactorsTreatment OutcomeWearable Electronic DevicesLow-intensity pulsed ultrasoundNeuromodulationParkinson’s diseaseRandomized controlled trialUltrasonic therapy

Identifiers

PMID38650028
PMCPMC11036625
OpenAlexW4395000670

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.