Aphasia after Stroke
Conditions
Interventions
acupuncture group A:intensified manual acupuncture and conventional therapy
acupuncture group B:mild manual acupuncture and conventional therapy
sham acupuncture:superficial needle beside the meridian and acupoint and conventional therapy
Healthy control group:N/A
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Poststroke aphasia (PSA) patients Participants who meet all of the following criteria will be included: 1)Diagnosis as the poststroke aphasia; 2)Diagnosed with aphasia for the first time after stroke; 3)The aphasia time ranges from 15 days to 3 months; 4)The severity of aphasia ranges from 0–3; 5)Be conscious and be able to cooperate with the trial conduction; 6)Aged 45 to 75?years; 7)Volunteered to sign the informed consent form and cooperate with the trial. 2 PSA patients for fMRI examination Participants who meet all of the following criteria will be included: 1)Be selected before the first intervention from the acupuncture group A, acupuncture group B, or the sham acupuncture group ; 2)Right handedness; 3)The language-related brain region is affected in the stroke attack; 4)Cooperative to complete the fMRI scanning; 5)Volunteered to sign the informed consent form. Inclusion criteria of healthy volunteers for fMRI examination Healthy volunteers who meet all of the following criteria will be included: 1)Matched age, gender and education level with participants of the acupuncture group A; 2)Right handedness; 3)Be able to complete the functional MRI scanning; 4)The cognitive function is normal, without cerebral diseases that may affect cerebral function and structure, such as brain trauma, drug and alcohol dependence 5)Without psychological disorders such as depression; 3 Intestinal flora test 3.1 PSA participant: Be selected before the first intervention from the acupuncture group A, acupuncture group B, or the sham acupuncture group, matched with age, gender and BMI. 3.2 Healthy volunteers 1)Aged 45-75; 2)Volunteered to participant in the trial, test feces, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1 Poststroke aphasia (PSA) patients Participants who meet any of the following criteria will be excluded: 1)Diagnosed with aphasia that is not caused by ischemic stroke; 2)Diagnosed with aphasia before this onset time of stroke; 3)Diagnosed with severe primary diseases such as liver, kidney, hematopoietic system, and endocrine system, or abnormalities in audio-visual, severe cognitive impairment, and mental illness, that cannot cooperate with examination and treatment; 4)Currently receiving verbal rehabilitation therapy, Transcranial Magnetic Stimulation (TMS) therapy or other physical therapy that might affect the interventions effects on aphasia; 5)Pregnant or lactating women. 2 Exclusion criteria of participants for fMRI examination 1)Unconsciousness, severe visual impairment, dysaudia or with other disease that is not able to complete the outcome assessment; 2)With intraocular cardiac pacemaker, nerve stimulator, artificial metal heart valve, aorta clamp, metallic intraocular foreign body, inner-ear devices, metal prosthesis, metal joint, ferromagnetic foreign body that are not able to complete the fMRI scanning or affect the image quality. 3 Intestinal flora test 3.1 PSA participant: During the trial conduction, receiving antibiotic treatment, intestinal flora regulation treatment, oral Chinese medicine and other drugs that may affect the composition of intestinal flora. 3.2 Healthy volunteers 1) Previous diagnosed with cerebrovascular disease. 2) Receiving antibiotic treatment for various reasons within 4 weeks before enrollment. 3) Receiving therapy with intestinal flora regulation within 4 weeks before enrollment. 4) diagnosed with serious heart diseases, infectious diseases, heart, liver and kidney failure, malignant tumors, gastrointestinal bleeding, irritable bowel syndrome, and chronic diarrhea. 5) Pregnant and lactating women. 6) Other clinical trial subjects who are affecting the results of the results of this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Aphasia Battery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Boston Diagnostic Aphasia Exam;Chinese functional communication profile;Chinese Rehabilitation Research Center Standard Aphasia Examination;Aphasia Battery of Chinese;National Institute of Health stroke scale;Modified Rankin Scale;Stroke specific-quality of life;Health scale of Traditional Chinese Medicine;Stroke and aphasia quality of life-39;The stroke aphasic depression questionnaire;MGH acupuncture sensation scale-Chinese Version;Bang's BI;Near infrared imaging;TCM syndrome score scale;functional magnetic resonance imaging;transcriptomics;metabolomics;intestinal flora; | — |
Countries
China
Contacts
Public ContactZhihong Meng
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed