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

Not Applicable

Not yet recruiting

• Conditions: Dysphagia; Functional Near- Infrared Spectroscopy; Transcranial Magnetic Stimulation; Stroke
• Interventions: Device: Theta burst transcranial magnetic stimulation

• Registration Number: NCT06471309
• Lead Sponsor: Zhang Xiaohui

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Study Start: 2024-08-01
• Primary Completion: 2025-11-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral stimulation group	Theta burst transcranial magnetic stimulation	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
Sham stimulation group	Theta burst transcranial magnetic stimulation	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
Unilateral stimulation group	Theta burst transcranial magnetic stimulation	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

Primary Outcome Measures

Name	Time	Method
Standardized Swallowing Assessment	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.	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.
Rosenbek Penetration-aspiration scale	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.	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.
functional near- infrared spectroscopy	The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China