Effect of Theta Burst Transcranial Magnetic Stimulation on Patients with Dysphagia After Stroke

Effect of Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia

The purpose of this study was to observe the effect of Theta burst transcranial magnetic stimulation (TBS) on swallowing function in patients with dysphagia after stroke (PSD). Functional near- infrared spectroscopy (fNIRS) was used to detect the changes in activation and functional connectivity of related brain regions in PSD patients treated with intermittent TBS（iTBS）stimulation on the affected side and consistent TBS（cTBS） stimulation on the healthy side. To investigate the effects of TBS on swallowing related cortical excitability in stroke patients with dysphagia and explore its possible mechanism, and provide theoretical basis for the treatment of PSD patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Transcranial Magnetic Stimulation; Dysphagia; Functional Near- Infrared Spectroscopy
• Intervention / Treatment: Device: Theta burst transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450044
      • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years old
• The first stroke lasted from 2 weeks to 6 months, with stable vital signs and right-handedness
• The stroke met the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Cerebral Hemorrhage 2019" or "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018" formulated by the Cerebrovascular Department of the Branch of Neurology of the Chinese Medical Association, and the cerebral CT or MRI examination showed unilateral cerebral infarction or cerebral hemorrhage.
• The dysphagia was consistent with the Expert Consensus on the Evaluation and Treatment of dysphagia in China (2017 edition), and the dysphagia was confirmed by videofluoroscopic swallowing study.
• MMSE>24, good cognitive function
• The skull is intact without craniotomy or repair
• Subject or family members sign informed consent

Exclusion Criteria:

• Combined with other diseases that may cause swallowing disorders, such as Parkinson's disease, dementia, motor neurone disease and other neurological diseases, or esophageal, neck surgery and other diseases that cause swallowing organ structure abnormalities
• A history of mental illness or epilepsy
• A metal implant in the head or eye, a pacemaker or a drug pump in the body
• Pregnancy, malignant tumor, serious disease history of heart, liver, kidney and other important organs
• Ulceration or infection of the skin on the head or where the electrode is applied
• Poor compliance and inability to complete basic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bilateral stimulation group; On the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side	Device: Theta burst transcranial magnetic stimulation; The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the sham stimulation group, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. When giving sham stimulation, put the coil vertically so that the coil is perpendicular to the patient's skull surface , it will not produce real therapeutic effect.
Experimental: Unilateral stimulation group; On the basis of routine treatment and routine swallowing rehabilitation training, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side	Device: Theta burst transcranial magnetic stimulation; The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the sham stimulation group, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. When giving sham stimulation, put the coil vertically so that the coil is perpendicular to the patient's skull surface , it will not produce real therapeutic effect.
Sham Comparator: Sham stimulation group; On the basis of routine treatment and routine swallowing rehabilitation training, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side	Device: Theta burst transcranial magnetic stimulation; The stimulation intensity of TBS was 80%RMT, with a total of 600 pulses, five times a week for two weeks. In the bilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the unilateral stimulation group, iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. In the sham stimulation group, sham iTBS treatment was given to the representative area of mylohyoid cortex on the affected side and sham cTBS treatment was given to the representative area of mylohyoid cortex on the healthy side. When giving sham stimulation, put the coil vertically so that the coil is perpendicular to the patient's skull surface , it will not produce real therapeutic effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rosenbek Penetration-aspiration scale	The Rosenbek Penetration-aspiration scale assesses the patient's swallowing function by assessing the severity of penetration and aspiration. The results of Rosenbek Penetration-aspiration scale are divided into 8 grades from 1 to 8, and the lower the score, the better the swallowing ability.	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
Standardized Swallowing Assessment	The Standardized Swallowing Assessment scale is divided into three parts: clinical examination, water test, and normal eating, and is used to evaluate the safety and effectiveness of swallowing. The highest score of Standardized Swallowing Assessment scale is 46, and the lowest score is 18. The lower the score, the better the swallowing function.	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
functional near- infrared spectroscopy	fNIRS is a brain function detection technology, which can indirectly reflect the brain neural activity by detecting the content of oxygenated and deoxygenated hemoglobin in the cerebral cortex in real time. In this study, fNIRS was used to assess brain region activation and network connectivity characteristics during swallowing tasks.	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.

Collaborators and Investigators

• Sponsor: Zhang Xiaohui

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2024
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders
• Other Study ID Numbers: 20240619

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No