Constipation and Depression Comorbidity After Stroke
Conditions
Interventions
Control A:Usual care
Group B:Usual care+TEAS
Group C:Usual care+TEAS+Magnetic Stimulation
Sponsors
Affiliated Hospital of Hebei University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, gender unrestricted; 2.Meeting diagnostic criteria for ischemic stroke or hemorrhagic stroke: Ischemic stroke was diagnosed according to the 2019 American Heart Association/Stroke Association guidelines and Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023, while hemorrhagic stroke was diagnosed based on the 2022 American Heart Association/Stroke Association guidelines and Chinese guidelines for diagnosis and treatment of acute intracerebral hemorrhage 2019, with a disease duration>14 days; 3.Meeting diagnostic criteria for depressive disorder and constipation: Depressive disorder was diagnosed according to the ICD-11 criteria for depressive disorder (6A60), with a Hamilton Depression Rating Scale (HAMD-17) score >=8 points [29]; constipation was diagnosed according to the Rome IV symptom criteria; 4.Normal bowel function prior to onset, no history of psychiatric disorders, constipation and depressive symptoms appearing after stroke onset; 5.Stable vital signs, clear consciousness, basic communication ability, and willingness to cooperate with scale assessments and full intervention; 6.Understanding the study content, procedures, and potential risks, and voluntarily signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of psychiatric disorders or current use of psychiatric medications; 2. Presence of non-stroke-related conditions (e.g., organic intestinal lesions, hypothyroidism) that may cause constipation, or current use of constipation-inducing medications (e.g., opioids, anticholinergic drugs) that cannot be discontinued; 3. Implantation of cardiac pacemakers, cochlear implants, metal foreign bodies, or other implantable electronic devices; 4.Contraindications related to TEAS or pelvic floor magnetic stimulation therapy (e.g., local skin damage, lesions at magnetic stimulation sites); 5. Laboratory or imaging findings indicating severe comorbidities of the heart, lungs, liver, kidneys, etc., uncontrolled by conventional pharmacotherapy; 6.Comorbidities involving impaired consciousness, hearing, vision, cognition, or speech that preclude participation in trial interventions or scale assessments; 7. Severe organic diseases (e.g., malignant tumors) with a projected survival time of less than 1 year; 8.Inability to complete the full follow-up due to geographical or personal reasons; 9.Pregnancy, lactation, or women of childbearing age planning pregnancy without effective contraception; 10.Participation in other clinical trials or recent involvement in other intervention trials within the past 3 months; 11. Other circumstances deemed unsuitable for participation by the investigator (e.g., poor compliance, comorbidities affecting outcomes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly Complete Spontaneous Bowel Movements ;Gut Microbiota Analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| National Institutes of Health Stroke Scale Score;Patient Health Questionnaire-9 Score;Hamilton Depression Scale-17 items Score;Montgomery-?sberg Depression Rating Scale Score;Cleveland Clinic Constipation Score;Patient Assessment of Constipation-Symptoms Score;Patient Assessment of Constipation-Quality of Life Score;Barthel Index ;Stroke-Specific Quality of Life Scale Score;HRV Analysis;Total Cholesterol;Triglyceride ;High-Density Lipoprotein Cholesterol ;Low-Density Lipoprotein Cholesterol;Total Bilirubin;Direct Bilirubin;Albumin;Prothrombin Time;Fibrinogen;D-Dimer;Hemoglobin;Absolute Neutrophil Count;Absolute Lymphocyte Count;Platelet Count;Homocysteine; | — |
Countries
China
Contacts
Public ContactWei Qixuan
Affiliated Hospital of Hebei University
Outcome results
None listed