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Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson's Disease Patients: a Randomized, Double-blind Clinical Trial

NCT06623591•Kezhong Zhang

View on ClinicalTrials.gov

Summary

Detailed Description

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. Meanwhile, the investigators aimed to verify mechanistic effects by investigating changes in proteins and cytokines related to inflammation and intestinal barrier function in serum and feces to verify mechanistic effects.

Eligibility

Age

40 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. aged 40-70 years;
•2. had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;
•3. 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;
•4. stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.

Exclusion Criteria

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

Key Dates

Start Date

October 15, 2024

Primary Completion Date

November 30, 2024

Completion Date

December 30, 2024

Last Updated

October 4, 2024

Enrollment

ESTIMATED participants

Conditions

Parkinson Disease, IdiopathicConstipation

Interventions

active Transcutaneous auricular vagus nerve stimulation

DEVICE

sham Transcutaneous auricular vagus nerve stimulation

DEVICE

Contacts

Kezhong Zhang, Professor

CONTACT

13770840575 kezhong_zhang1969@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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