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

ConditionsParkinson Disease, IdiopathicConstipation
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • active Transcutaneous auricular vagus nerve stimulation

    Device

    Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.

  • sham Transcutaneous auricular vagus nerve stimulation

    Device

    In the sham stimulation group, the electrodes were fixed at the left earlobe with the same stimulus parameters. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Active Transcutaneous auricular vagus nerve stimulationExperimental treatment 1 intervention
Group B: Sham Transcutaneous auricular vagus nerve stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

By having patients record their bowel movements two weeks before the start of the experiment and two weeks before the end of the experiment, calculate the CSBMs/week.

Time frame
Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention

Secondary outcomes

1

Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson&#39;s Disease (GIDS-PD) at one day post intervention

The Gastrointestinal Dysfunction Scale for Parkinson\&#39;s Disease is a novel disease-specific self-report tool to quantitatively assess the presence and severity of gastrointestinal dysfunction features in patients with PD, with strong reliability and validity. The GIDS-PD (Appendix S1) is a Likert self-report scale composed of 12 items. The total score of the GIDS-PD is computed by adding the total score of items 1 through 12, resulting in a minimum score of 1 and a maximum score of 108.

Time frame
Assessed at baseline, one day post intervention
2

Change from Baseline Gastrointestinal Symptoms Rating Scales at one day post intervention

Used to evaluate the gastrointestinal symptoms and discomfort level of patients, from 0 to 105.

Time frame
Assessed at baseline, one day post intervention
3

Change from Baseline constipation symptoms scores at one day post intervention

Used to evaluate the constipation symptoms , from 0 to 30.

Time frame
Assessed at baseline, one day post intervention
4

Change from Baseline Patient Assessment of Constipation Quality of Life scale，PAC-QOL at one day post intervention

Used to evaluate quality of life, a total of 28 items are divided into 4 aspects: physiological discomfort, psychological discomfort, palpitations, and satisfaction. The PAC-QOL score range is 0-4, with lower scores indicating better results.

Time frame
Assessed at baseline, one day post intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kezhong Zhang

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov

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