Evidence map›Paper›PMID 37005647›Full record

ArticleTrials2023

Effects of 10 Hz individualized repetitive transcranial magnetic stimulation on patients with disorders of consciousness: a study protocol for an exploratory double-blind crossover randomized sham-controlled trial.

Chengwei Xu, Zhaohua Zhu, Wanchun Wu, Xiaochun Zheng, Haili Zhong, Xiyan Huang, Qiuyou Xie, Xinyi Qian

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05187000 (Effect of Individualized Repetitive Transcranial Magnetic Stimulation), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT05187000 naunknown statusnot on this map

Effect of Individualized Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Disorder of Consciousness

TypeinterventionalSponsorQiuyou XieRan2021 to 2025Enrolled30ConditionsDisorder of Consciousness, Transcranial Magnetic StimulationArmsindividualized repetitive transcranial magnetic stimulation, Sham repetitive transcranial magnetic stimulation
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

8 authors at 2 institutions in 1 country.

Chengwei XuDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Zhaohua ZhuClinical Research Center, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Wanchun WuDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Xiaochun ZhengDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Haili ZhongDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China.
Xiyan HuangDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China. loriahuang@126.com.ORCID http://orcid.org/0000-0002-8091-2012
Qiuyou XieDepartment of Rehabilitation Medicine, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong Province, 510280, People's Republic of China. xqy7180@163.com.
Xinyi QianSchool of Rehabilitation Medicine, Gannan Medical University, Ganzhou, Jiangxi province, 341000, People's Republic of China.
Zhujiang Hospital · CNGannan Medical University · CN

Funding

Key Realm R&D Program of Guangzhou 202007030005National Natural Science Foundation of China 81801119National Natural Science Foundation of China 81974154National Natural Science Foundation of China 82171174
6 · The paper itself

Abstract

backgroundRepetitive transcranial magnetic stimulation (rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness recovery of patients with disorders of consciousness (DoC), as, to a certain extent, it is effective in regulating the excitability of central nervous system. However, it is difficult to achieve satisfactory effect with "one size fits all" rTMS treatment due to different clinical conditions of patients. There is an urgent need to develop individualized strategy to improve the effectiveness of rTMS on patients with DoC.

methodsOur protocol is a randomized double-blind sham-controlled crossover trial that includes 30 DoC patients. Each patient will received 20 sessions, in which 10 sessions will be rTMS-active stimulus, and the other 10 sessions will be sham stimulus, separated by no less than 10 days' washout period. The rTMS-active will include 10 Hz rTMS over the individualized-targeted selection area for each patient according to the different insult regions of the brain. Coma Recovery Scale-Revised (CRS-R) will be used as primary outcome at baseline, after the first stage of stimulation, at the end of the washout period, and after the second stage of stimulation. Secondary outcomes will be measured at the same time, including efficiency, relative spectral power, and functional connectivity of high-density electroencephalograph (EEG). Adverse events will be recorded during the study. DISCUSSION: rTMS has obtained grade A evidence in treating patients with several central nervous system diseases, and there has been some evidence showing partial improvement on level of consciousness in DoC patients. However, the effectiveness of rTMS in DoC is only 30~36%, mostly due to the non-specific target selection. In this protocol, we present a double-blind crossover randomized sham-controlled trial based on the individualized-targeted selection strategy that aims to study the effectiveness of rTMS therapy for DoC, and the result may provide new insights to non-invasive brain stimulation.

trial registrationClinicalTrials.gov : NCT05187000. Registered on January 10, 2022.

Indexed as

Consciousness DisordersTranscranial Magnetic StimulationBrainCross-Over StudiesDouble-Blind MethodHumansRandomized Controlled Trials as TopicTreatment OutcomeDisorders of consciousnessRandomized control trialRepetitive transcranial magnetic stimulation

Identifiers

PMID37005647
PMCPMC10067296
OpenAlexW4362523427

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.