Evidence map›Paper›PMID 39193146›Full record

ArticleFrontiers in neurology2024

Efficacy and safety of deep brain stimulation in mesencephalic locomotor region for motor function in patients with post-stroke hemiplegia: a study protocol for a multi-center double-blind crossover randomized controlled trial.

Junpeng Xu, Bin Liu, Shuzhen Liu, Zhebin Feng, Yanyang Zhang, Di Liu, Qing Chang, Haonan Yang, Yuhan Chen, Xinguang Yu and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05968248 (A Randomized Controlled Trial Exploring the Efficacy and Safety of Deep Brain Stimulation in the Treatment of Motor Dysfunction After Stroke#the PASTS-Stroke Study#), 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.

NCT05968248 nanot yet recruitingnot on this map

A Randomized Controlled Trial Exploring the Efficacy and Safety of Deep Brain Stimulation in the Treatment of Motor Dysfunction After Stroke#the PASTS-Stroke Study#

TypeinterventionalSponsorChinese PLA General HospitalRan2023 to 2027Enrolled62ConditionsStroke SequelaeArmsMLR-DBS, Conventional rehabilitation group
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  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

11 authors.

Junpeng Xu *Medical School of Chinese PLA, Beijing, China.
Bin Liu *Medical School of Chinese PLA, Beijing, China.
Shuzhen LiuDepartment of Chengde Medical University, Chengde, China.
Zhebin FengMedical School of Chinese PLA, Beijing, China.
Yanyang ZhangDepartment of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Di LiuDepartment of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Qing ChangDepartment of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Haonan YangMedical School of Chinese PLA, Beijing, China.
Yuhan ChenThe First Clinical Medical College of Hebei North University, Zhangjiakou, China.
Xinguang YuDepartment of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Zhiqi MaoDepartment of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Deep brain stimulation (DBS) is a potential treatment for improving movement disorder. However, few large-sample studies can reveal its efficacy and safety. This study aims to initially explore the efficacy and safety of DBS in the mesencephalic locomotor region (MLR) on motor function in patients with post-stroke hemiplegia. Methods/design: This multicenter, prospective, double-blind, randomized crossover clinical trial aims to assess the safety and effectiveness of Deep Brain Stimulation (DBS) in the mesencephalic locomotor region (MLR) for patients with moderate to severe post-stroke hemiplegia. Sixty-two patients with stable disease after a year of conservative treatment will be enrolled and implanted with deep brain electrodes. Post-surgery, patients will be randomly assigned to either the DBS group or the control group, with 31 patients in each. The DBS group will receive electrical stimulation 1 month later, while the control group will undergo sham stimulation. Stimulation will be discontinued after 3 and 6 months, followed by a 2-week washout period. Subsequently, the control group will receive electrical stimulation, while the DBS group will undergo sham stimulation. Both groups will resume electrical stimulation at the 9th and 12th-month follow-ups. Post-12-month follow-up, motor-related scores will be collected for analysis, with the Fugl-Meyer Assessment Upper Extremity Scale (FMA-UE) as the primary metric. Secondary outcomes include balance function, neuropsychiatric behavior, fall risk, daily living activities, and quality of life. This study aims to provide insights into the therapeutic benefits of DBS for post-stroke hemiplegia patients. Result/conclusion: We proposed this study for the first time to comprehensively explore the effectiveness and safety of DBS in improving motor function for post-stroke hemiplegia, and provide evidence for DBS in the treatment of post-stroke hemiplegia. Study limitations are related to the small sample size and short study period. Clinical Trial Registration: Clinicaltrials.gov, identifier NCT05968248.

Indexed as

deep brain stimulationhemiplegiamotor dysfunctionmotor recoverystroke

Identifiers

PMID39193146
PMCPMC11347412

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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.