Clinical trial NCT06471309: Effect of Theta Burst Transcranial Magnetic Stimulation on Patients with Dysphagia After Stroke
Official title: Effect of Theta Burst Transcranial Magnetic Stimulation on Post-Stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke
Dysphagia
Functional Near- Infrared Spectroscopy
Transcranial Magnetic Stimulation
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 45
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rosenbek Penetration-aspiration scale
timeFrame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
measure: Standardized Swallowing Assessment
timeFrame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
measure: functional near- infrared spectroscopy
timeFrame: The first evaluation was before the intervention and the second evaluation was after 2 weeks of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References: