Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorKezhong Zhang
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- active Transcutaneous auricular vagus nerve stimulation
- sham Transcutaneous auricular vagus nerve stimulation
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Kezhong Zhang
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Sponsor institution
Source ClinicalTrials.gov