Post-stroke dysphagia
Conditions
Interventions
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: PSD patients: 1. Meet the diagnostic criteria of ischemic stroke and dysphagia; 2. The duration of stroke lasts within 6 months; 3. Severity of Dysphagia WST 3-5; 4. Age range from 40 to 80 years old; 5. Native language is Chinese; 6. Determined as right-handed by the Edinburgh Handedness Inventory (EHI); 7. Stable vital signs able to understand and cooperate in completing research; 8. The patient or legal representative agrees to sign the informed consent form. Healthy participants: 1. Age range from 40 to 80 years old; 2. Determined as right-handed by the Edinburgh Handedness Inventory (EHI); 3. Native language is Chinese; 4. Without swallowing disorders; 5. Health risk factors are controlled appropriately for one's age; 6. Participating in clinical trials without seeking therapeutic benefit; 7. In good health and able to cooperate for fMRI scans; 8. The participant or legal representative agrees to sign the informed consent form.
Exclusion criteria
Exclusion criteria: PSD patients: 1. Dysphagia caused by other diseases (such as Head and neck cancer oropharyngeal diseases etc.); 2. Dysphagia existed before the onset of this stroke; 3. Those with an expected survival time of less than 3 months; 4. Patients with medullary injury; 5. Previously suffering from diseases such as cerebral hemorrhage or brain tumors leading to abnormal brain MRI structure; 6. There are contraindications to MRI scanning such as metal implantation cochlear implants or Claustrophobia; 7. Self Rating Anxiety Scale (SAS)>=50 points and Self Rating Depression Scale (SDS)>=50 points; 8. Have severe addictions to tobacco alcohol or drugs; 9. Participated in other clinical trials or received acupuncture in the past week. Healthy participants: 1. There are contraindications of MRI scanning such as metal implantation a cochlear implant or claustrophobia; 2. Self Rating Anxiety Scale (SAS)>=50 points and Self Rating Depression Scale (SDS)>=50 points; 3. Have organic brain lesions like cerebral infarction hemorrhage or injury history. 4.Have severe addictions to tobacco alcohol or drugs; 5. Participated in other clinical trials or received acupuncture in the past week.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| root mean square,RMS;Fractional Amplitude oLow Frequency Fluctuation,fALFF;Functional connectivity,FC;Percent Amplitude of Fluctuation,PerAF;mean diffusivity,MD;Amplitude of Low Frequency Fluctuation,ALFF;nedian frequency,MF;microcirculation blood perfusionvolume,MBPU;fraction anisotropy,FA;Regional homogeneity,ReHo; | — |
Secondary
| Measure | Time frame |
|---|---|
| Swallowing Quality of Life Questionnaire,SWAL-QoL;National Institute of Health stroke scale,NIHSS;Water Swallowing Test,WST;Patient Adherence and Safety Assessment Scale;Standardized Swallowing Assessment,SSA;Video Fluoroscopic Swallowing Study,VFSS;Record adverse events (AE)and serious adverse events (SAE); Functional Oral Intake Scale,FOIS;Recording of Abnommal Clinical Data; | — |
Countries
China
Contacts
Public ContactXiaonong Fan
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed