Stroke Clinical Trial - Effects of Repetitive Transcranial Magnetic

Status Completed

Clinical Trial Summary

This trial was a randomized, double-blind, sham-controlled trial.Thirty patients with post-stroke dysphagia were randomly assigned to the repetitive transcranial magnetic stimulation(rTMS) group (n=15) or sham rTMS group (n=15). Both groups received conventional swallowing rehabilitation, and in addition, the rTMS group received 5hz repetitive transcranial magnetic stimulation on the healthy side. Swallowing function was assessed at admission and after two weeks of treatment using the the Standardized Swallowing Assessment (SSA), the Penetration-Aspiration Scale (PAS), the Fiberoptic Endoscopic Dysphagia Severity Scale(FEDSS), the Functional Oral Intake Scale (FOIS), and the functional near-infrared spectroscopic(fNIRS).

Clinical Trial Description

Stroke is the leading cause of death and disability worldwide, and dysphagia is one of the common complications of stroke.Dysphagia after stroke can lead to serious complications such as aspiration, pneumonia, and malnutrition, which greatly reduces the quality of life of patients.Transcranial magnetic stimulation(TMS), a non-invasive central nervous system stimulation that is safe, non-invasive, and does not require active patient participation, has been gradually applied to stroke rehabilitation in recent years.Although there have been studies on the improvement of post stroke dysphagia(PSD) by healthy-side high-frequency rTMS, there have been no studies assessing the activation of relevant brain regions before and after its treatment by fNIRS and exploring the possible mechanisms involved. The aim of this study was to observe the effect of high-frequency rTMS stimulation of the healthy mandibular hyoid cortical area at 5 hz on PSD, and to explore the possible mechanisms by assessing it with fNIRS, so as to provide a theoretical basis for the clinical use of rTMS in the treatment of patients with PSD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06213597
Study type	Interventional
Source	The First Affiliated Hospital of Zhengzhou University
Contact
Status	Completed
Phase	N/A
Start date	May 28, 2023
Completion date	January 8, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms