Menu
Not yet recruiting NCT06623591

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

No phase Interventional Parkinson Disease, Idiopathic Constipation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: active Transcutaneous auricular vagus nerve stimulation, sham Transcutaneous auricular vagus nerve stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease, Idiopathic, Constipation. Basic parameters: 40 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Device active Transcutaneous auricular vagus nerve stimulation
    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.
  • Device sham Transcutaneous auricular vagus nerve stimulation
    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.

Primary outcome measures

  • alterations in complete spontaneous bowel movements per week (CSBMs/week) [Time frame: Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention]
Secondary outcome measures (12)
  • Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) at one day post intervention [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline Gastrointestinal Symptoms Rating Scales at one day post intervention [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline constipation symptoms scores at one day post intervention [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline Patient Assessment of Constipation Quality of Life scale，PAC-QOL at one day post intervention [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline HRAM at one day post intervention--Resting pressure (mmHg) [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline HRAM at one day post intervention--maximum squeeze pressure (mmHg) [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline HRAM at one day post intervention--First sensation (mL) [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline HRAM at one day post intervention--desire to defecate threshold [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline HRAM at one day post intervention--maximum tolerance [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline gastrointestinal electrogram at one day post intervention--amplitude [Time frame: Assessed at baseline, one day post intervention]
  • Change from Baseline gastrointestinal electrogram at one day post intervention--frequency [Time frame: Assessed at baseline, one day post intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06623591 · 2024-taVNS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗