Transcranial magnetic stimulation: The treatment parameter for iTBS was 80% stimulus intensity. The stimulation frequency was 50Hz in the plexus and 5Hz in the interplexus. Each burst stimulus consisted of 3 consecutive pulses, 2s stimulus, 8s interval, and repeated 20 times, a total of 600 pulses, and the duration of stimulation was 189s. NMES treatment parameters for output waveform for two-way square wave, wave width 700 ms, positive and negative half wave (300 ms) between 100 ms intermittent, stimulating frequency 50 hz, treatment when the output intensity range of 0 \~ 25 ma, stimulating electrodes pasted in bilateral mandibular hyoid muscle movement points, output intensity in patients with tongue bone muscle group it is advisable to have a sense of fashion, extrusion. Each treatment lasted 30 minutes, once a day, 5 times a week for 2 weeks.
Study summary
In recent years, research on intermittent Theta Burst Stimulation (iTBS), as a special high-frequency （repetitive transcranial magnetic stimulation，rTMS） stimulation paradigm, has focused on exploring the effects in healthy people. Based on previous studies, it is believed that the central magnetic stimulation combined with peripheral electrical stimulation based on the "central-peripheral-central" closed-loop rehabilitation concept has the best effect, but there are few clinical studies on the efficacy and mechanism of iTBS combined treatment of dysphagia after stroke, and the selection of the optimal stimulation scheme and target has not yet been determined, therefore, this study aims to observe the efficacy and mechanism of implementation of iTBS combined with neuromuscular electrical stimulation (NMES) on with patients with dysphagia (PSD) .
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 18 \~80 years old;
* The patients met the diagnostic criteria of stroke in the "Diagnostic Points for Major Cerebrovascular Diseases in China 2019" formulated by the Chinese Society of Neurology, and were confirmed by head CT or MRI;
* The patients met the diagnostic criteria of dysphagia in the "Chinese Expert Consensus on the Evaluation and treatment of Dysphagia (2017 edition)" and were confirmed by VFSS;
* The disease duration ranged from 2 weeks to 6 months;
* The vital signs of the patient were stable;
* The score of mini-mental state examination (MMSE) was more than 17 points for the illiterate, more than 20 points for the primary scholar, and more than 24 points for the secondary school or above;
* Can independently or under the auxiliary balance the seat 30 minutes or more;
* The skull was intact without craniotomy and/or cranioplasty;
* Informed consent was obtained from all subjects or their families.
Exclusion Criteria:
* A history of other diseases that may cause dysphagia, such as Parkinson's disease, head and neck radiotherapy, or other neurological diseases;
* Contraindications to iTBS or NMES with a history of epilepsy, intracranial metal implants, bleeding tendency, etc.;
* Skin damage and infection on the front of the neck affect the placement of the surface electrode;
* Such as fever, important viscera function failure condition is not stable, or critically ill.
Primary outcome measure(s)
functional near-infrared spectroscopy — immediately before and immediately after the intervention Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technology based on blood vessels, which can be used to evaluate the activation of brain regions associated with swallowing
Standardized Swallowing Assessment Scale — immediately before and immediately after the intervention The Standard Swallowing Assessment Scale is a method of assessing a patient's swallowing function. During the assessment, the patient's level of consciousness, head and trunk control, breathing patterns, lip closure, soft palate movements, laryngeal function, gag reflex, and voluntary cough should be recorded.The highest score on the scale is 46 points, and the lowest score is 18 points, and the lower the score, the better the swallowing function.
The Yale Pharyngeal Residue Severity Rating Scale — immediately before and immediately after the intervention The Yale Pharyngeal Residue Severity Rating Scale is a laryngoscopy-based assessment scale used to assess the degree of food residue.The scale divided the residues of the valley of the eglottis and the piriform fossa into grades 1-5 according to the severity of the scale, respectively. The higher the grade, the more severe the food residue
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
More The First Affiliated Hospital of Zhengzhou University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.