Not Yet RecruitingNot Applicable

Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.

30 participantsStarted 2024-10-15

Plain-language summary

The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.

Who can participate

Age range40 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. aged 40-70 years;
✓. had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;
✓. fulfilled Rome IV criteria for functional constipation, including having \< 3 spontaneous bowel movements (SBM; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months;
✓. stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.

Exclusion criteria

✕. a history of previous abdominal surgery (other than appendectomy);
✕. the presence of carcinoma;
✕. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury;
✕. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors;
✕. a serious concomitant disease of the heart, liver, kidney, or diabetes;
✕. pregnancy or lactation;
✕. participating in another trial or enrolled in a trial during the past month;
✕. an allergic reaction to surface electrodes.

What they're measuring

alterations in complete spontaneous bowel movements per week (CSBMs/week)

Timeframe: Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention

Trial details

NCT IDNCT06623591

SponsorKezhong Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

Contact for this trial

Kezhong Zhang, Professor

13770840575 kezhong_zhang1969@126.com

View on ClinicalTrials.gov More Parkinson Disease, Idiopathic trials