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

Ruyao Liu

Status: Completed

Conditions: Stroke; Deglutition Disorders

Treatments: Other: routine swallowing rehabilitation; Device: sham repetitive transcranial magnetic stimulation; Device: real repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06213597

2020-PT310-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

repetitive transcranial magnetic stimulation group

Experimental group

Description:

Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables.

Treatment:

Other: routine swallowing rehabilitation

Device: real repetitive transcranial magnetic stimulation

sham repetitive transcranial magnetic stimulation

Sham Comparator group

Description:

Randomization was performed by a staff member of our hospital, who was not involved in the implementation or evaluation of the trial, and who randomly assigned subjects to either the rTMS group or the sham rTMS group in a 1:1 ratio through the use of an electronic random sequence generator. Opaque, sealed envelopes were used to mask the randomization tables.

Treatment:

Other: routine swallowing rehabilitation

Device: sham repetitive transcranial magnetic stimulation