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

NCT ID: NCT06213597

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-28
• Study Completion Date: 2024-01-08

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.

Conditions

Stroke; Deglutition Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

repetitive transcranial magnetic stimulation group

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.

Group Type: EXPERIMENTAL

routine swallowing rehabilitation

Intervention Type: OTHER

Routine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist.

real repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

In the rTMS group, 5 Hz rTMS was applied to the hot spot of the supraglottic motor cortex of the affected hemisphere at a treatment intensity of 80% resting motor threshold for 10 min, with a total of 250 pulses (with an interval of 11 s for every 1 s of continuous stimulation), and the treatment was performed once a day for 6 d per week for 2 weeks.

sham repetitive transcranial magnetic stimulation

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.

Group Type: SHAM_COMPARATOR

routine swallowing rehabilitation

Intervention Type: OTHER

Routine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist.

sham repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

The sham rTMS group supplemented pseudomagnetic stimulation at the hotspot of the representative area, tilted the magnetic stimulation coil at 90°, and the same noise was emitted by the instrument during the treatment, but no stimulation was performed, and the group was treated once a day, 6d per week, for 2 weeks.

Interventions

routine swallowing rehabilitation

Routine swallowing rehabilitation training mainly included oral and facial muscle training, ice stimulation therapy, Mendelssohn maneuver training, and tongue root resistance training. The subjects were treated twice a day, Monday through Saturday, for 20 min each time for 2 weeks. All operations were performed by the same trained and qualified professional rehabilitation therapist.

Intervention Type: OTHER

real repetitive transcranial magnetic stimulation

In the rTMS group, 5 Hz rTMS was applied to the hot spot of the supraglottic motor cortex of the affected hemisphere at a treatment intensity of 80% resting motor threshold for 10 min, with a total of 250 pulses (with an interval of 11 s for every 1 s of continuous stimulation), and the treatment was performed once a day for 6 d per week for 2 weeks.

Intervention Type: DEVICE

sham repetitive transcranial magnetic stimulation

The sham rTMS group supplemented pseudomagnetic stimulation at the hotspot of the representative area, tilted the magnetic stimulation coil at 90°, and the same noise was emitted by the instrument during the treatment, but no stimulation was performed, and the group was treated once a day, 6d per week, for 2 weeks.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruyao Liu

OTHER

Sponsor Role: lead

Responsible Party

Ruyao Liu

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xi Zeng

Role: STUDY_CHAIR

The First Affiliated Hospital of Zhengzhou University

Locations

The first affiliated hospital of zhengzhou university

Zhengzhou, Henan, China

Countries

China

Other Identifiers

2020-PT310-02

Identifier Type: -

Identifier Source: org_study_id