Clinical trial NCT06213597: Effects of Repetitive Transcranial Magnetic Stimulation on Patients With Dysphagia in Stroke Observed Based on Functional Near-infrared Spectroscopic
Official title: Effects of Healthy-side High-frequency Repetitive Transcranial Magnetic Stimulation in Patients With Post Stroke Dysphagia: a Prospective Study Based on Functional Near-infrared Spectroscopic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Deglutition Disorders
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age, right-handed;
* unilateral stroke, diagnosed by cranial MRI or CT;
* disease duration of 2 weeks to 6 months;
* dysphagia confirmed by the Videofluoroscopic swallowing study;
* patient's vital signs were stable;
* consciousness was clear, able to cooperate in completing the rehabilitation therapy, assessment, and the fNIRS test;
* cranial bone was intact without craniotomy and/or craniovertebral repair;
* the subject signed the Declaration of Helsinki according to the Informed consent.

Exclusion Criteria:

* previous dysphagia due to other diseases such as Parkinson's disease, dementia, or the presence of organic swallowing dysfunction;
* contraindications to rTMS: stimulation coils or the presence of a metal foreign body near the stimulated scalp, built-in pulse generators, cardiac stents, cardiac bypass grafting, etc;
* previous history of psychiatric disease or epilepsy;
* pregnancy;
* skin infection or breakage on the head;
* previous or current stroke, traumatic brain injury and other neurological or mental system diseases;
* serious cardiac, pulmonary, hepatic, renal dysfunction, malignant tumors, serious complications;
* poor patient compliance and evaluation,other neurological or psychiatric disorders;
* severe cardiac, pulmonary, hepatic, or renal dysfunction, malignant tumors, and serious complications;
* poor patient compliance and non-cooperation with treatment and evaluation.

Primary outcomes:
measure: Standardized Swallowing Assessment
timeFrame: day 1 and day 14
Secondary outcomes:
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 14
measure: Fiberoptic Endoscopic Dysphagia Severity Scale
timeFrame: day 1 and day 14
measure: Functional Oral Intake Scale
timeFrame: day 1 and day 14
measure: Functional near-infrared spectroscopy
timeFrame: day 1 and day 14
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of zhengzhou university
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Xi Zeng
role: STUDY_CHAIR
References: