Clinical trial NCT06623591: Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.
Official title: Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson&#39;s Disease Patients: a Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease, Idiopathic
Constipation
Keywords: constipation
Parkinson&#39;s disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson&#39;s Disease (GIDS-PD) at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline Gastrointestinal Symptoms Rating Scales at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline constipation symptoms scores at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline Patient Assessment of Constipation Quality of Life scale，PAC-QOL at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline HRAM at one day post intervention--Resting pressure (mmHg)
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline HRAM at one day post intervention--maximum squeeze pressure (mmHg)
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline HRAM at one day post intervention--First sensation (mL)
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline HRAM at one day post intervention--desire to defecate threshold
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline HRAM at one day post intervention--maximum tolerance
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline gastrointestinal electrogram at one day post intervention--amplitude
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline gastrointestinal electrogram at one day post intervention--frequency
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline serum indicators at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline feces indicators at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline The motor part of the Unified Parkinson's Disease Rating Scale at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Kezhong Zhang
role: PRINCIPAL_INVESTIGATOR
References: