Parkinson's disease (PD)
Conditions
Interventions
Sham stimulation group:The control group received electrodes attached to non-acupoint areas (e.g., the buttocks, away from major acupoints and relevant nerve pathways), using the same electrodes, equi
only a minimal, sub-threshold stimulus that could not produce the intended therapeutic effect was applied. In addition, the control group received the same routine care as the treatment g
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Meeting the diagnostic criteria for both Parkinson's disease and constipation simultaneously; 2.Male or female, aged 35 to 80 years; 3.Hoehn-Yahr stage <= 3; 4.No routine use of medications or probiotics that may significantly affect gastrointestinal function within 2 weeks prior to enrollment; except for those who receive rescue treatment per protocol due to 3 consecutive days without defecation; 5.Anti-Parkinsonian medication regimen remains; 6.Capable of understanding the study content, making independent decisions, and providing written informed consent; 7.Willing and able to complete bowel diaries, scale assessments, study visits, and biological sample collection;
Exclusion criteria
Exclusion criteria: 1.Presence of organic lesions such as intestinal adhesions, intestinal obstruction, gastrointestinal tumors, or obvious gastrointestinal malformations; 2.History of abdominal or anorectal surgery that may significantly affect intestinal transit; 3.Presence of systemic diseases that significantly affect gastrointestinal motility, such as poorly controlled diabetes mellitus or thyroid dysfunction; 4.Concurrent severe cardiovascular, hepatic, renal, or hematopoietic system diseases, active malignant tumors, or other life-threatening conditions; 5.Allergy to electrode patches or related materials, or presence of skin damage, infection, dermatitis, etc., at the intended application sites; 6.Presence of a cardiac pacemaker, implantable cardioverter-defibrillator, deep brain stimulator, or other implantable electronic devices that may be affected by transcutaneous electrical stimulation; 7.Pregnancy, planned pregnancy, or breastfeeding; 8.Significant cognitive or psychiatric/behavioral problems as judged by the investigator, making the patient unable to reliably complete informed consent, diaries, or assessments; 9.Currently participating in other clinical trials that may affect the outcomes of this study; 10.Currently participating in other clinical trials that may affect the outcomes of this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of completely spontaneous bowel movements per week.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the total score and dimensions of the Patient Assessment of Constipation Quality of Life (PAC-QOL);Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale;Inflammatory markers;Gut Microbiota Composition and Abundance Indices;Total Score and Dimensional Changes of the Constipation Symptoms and Efficacy Assessment Scale (CSEAS);Treatment adherence;Bowel diary;Gastrointestinal motility-related neurotransmitters;Changes in the above clinical outcomes compared with baseline after 2 weeks of intervention treatment and 2 weeks after the end of treatment; | — |
Countries
China
Contacts
Public ContactRuan Zheng
Xuanwu Hospital Capital Medical University
Outcome results
None listed