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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Transcutaneous auricular vagus nerve stimulation | Experimental | For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 28 consecutive daily sessions of taVNS. |
|
| Sham Transcutaneous auricular vagus nerve stimulation | Sham Comparator | For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent 28 consecutive daily sessions of sham-taVNS (the electrodes were fixed at the the left earlobe). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Gastrointestinal Dysfunction Scale for Parkinson's Disease (GIDS-PD) at one day post intervention | The Gastrointestinal Dysfunction Scale for Parkinson'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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kezhong Zhang, Professor | Contact | 13770840575 | kezhong_zhang1969@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Kezhong Zhang | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
|
| Assessed at baseline, one day post intervention |
| 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. | Assessed at baseline, one day post intervention |
| Change from Baseline constipation symptoms scores at one day post intervention | Used to evaluate the constipation symptoms , from 0 to 30. | 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 | 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. | Assessed at baseline, one day post intervention |
| Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention | Used to evaluate the constipation symptoms , from 0 to 48. | Assessed at baseline, one day post intervention |
| Change from Baseline HRAM at one day post intervention--Resting pressure (mmHg) | Following HRV test, HRAM was undertaken using a solid-state manometric instrument with 12 circumferential sensors spaced at 1 cm intervals and an outer diameter of 4.2 mm to evaluate anorectal sensorimotor function. Patients were asked to be in the left lateral position with the hips and knees flexed, and then the solid-state catheter was inserted into the rectum through the anal orifice. After a 3-minute period of stabilization, the sequential maneuver procedures are as follows: Resting pressure (mmHg), maximum squeeze pressure (mmHg). First-sensation volume, desire to defecate threshold, and maximum tolerance were tested by constant dilation of balloon | Assessed at baseline, one day post intervention |
| Change from Baseline HRAM at one day post intervention--maximum squeeze pressure (mmHg) | Following HRV test, HRAM was undertaken using a solid-state manometric instrument with 12 circumferential sensors spaced at 1 cm intervals and an outer diameter of 4.2 mm to evaluate anorectal sensorimotor function. Patients were asked to be in the left lateral position with the hips and knees flexed, and then the solid-state catheter was inserted into the rectum through the anal orifice. After a 3-minute period of stabilization, the sequential maneuver procedures are as follows: Resting pressure (mmHg), maximum squeeze pressure (mmHg). First-sensation volume, desire to defecate threshold, and maximum tolerance were tested by constant dilation of balloon | Assessed at baseline, one day post intervention |
| Change from Baseline HRAM at one day post intervention--First sensation (mL) | Following HRV test, HRAM was undertaken using a solid-state manometric instrument with 12 circumferential sensors spaced at 1 cm intervals and an outer diameter of 4.2 mm to evaluate anorectal sensorimotor function. Patients were asked to be in the left lateral position with the hips and knees flexed, and then the solid-state catheter was inserted into the rectum through the anal orifice. After a 3-minute period of stabilization, the sequential maneuver procedures are as follows: Resting pressure (mmHg), maximum squeeze pressure (mmHg). First-sensation volume, desire to defecate threshold, and maximum tolerance were tested by constant dilation of balloon | Assessed at baseline, one day post intervention |
| Change from Baseline HRAM at one day post intervention--desire to defecate threshold | Following HRV test, HRAM was undertaken using a solid-state manometric instrument with 12 circumferential sensors spaced at 1 cm intervals and an outer diameter of 4.2 mm to evaluate anorectal sensorimotor function. Patients were asked to be in the left lateral position with the hips and knees flexed, and then the solid-state catheter was inserted into the rectum through the anal orifice. After a 3-minute period of stabilization, the sequential maneuver procedures are as follows: Resting pressure (mmHg), maximum squeeze pressure (mmHg). First-sensation volume, desire to defecate threshold, and maximum tolerance were tested by constant dilation of balloon | Assessed at baseline, one day post intervention |
| Change from Baseline HRAM at one day post intervention--maximum tolerance | Following HRV test, HRAM was undertaken using a solid-state manometric instrument with 12 circumferential sensors spaced at 1 cm intervals and an outer diameter of 4.2 mm to evaluate anorectal sensorimotor function. Patients were asked to be in the left lateral position with the hips and knees flexed, and then the solid-state catheter was inserted into the rectum through the anal orifice. After a 3-minute period of stabilization, the sequential maneuver procedures are as follows: Resting pressure (mmHg), maximum squeeze pressure (mmHg). First-sensation volume, desire to defecate threshold, and maximum tolerance were tested by constant dilation of balloon | Assessed at baseline, one day post intervention |
| Change from Baseline gastrointestinal electrogram at one day post intervention--amplitude | A total of 8 leads cover the body surface projection of the stomach and intestines, which can reflect the gastrointestinal motility | Assessed at baseline, one day post intervention |
| Change from Baseline gastrointestinal electrogram at one day post intervention--frequency | A total of 8 leads cover the body surface projection of the stomach and intestines, which can reflect the gastrointestinal motility. | Assessed at baseline, one day post intervention |
| Change from Baseline serum indicators at one day post intervention | A blood sample was taken at 8 a.m. at baseline and after 4 weeks of treatment. For each patient, about 5 mL of blood was drawn into a procoagulant tube and 4 mL into 2 anticoagulant tubes with EDTA; it was centrifuged at 4°C and 1139g for 10 minutes and 5 minutes respectively. The serum in the procoagulant tube was divided into 3 portions, and the plasma in the anticoagulant tubes was divided into 2 portions - each about 0.5 mL - and placed at -80°C for assay within 6 months. | Assessed at baseline, one day post intervention |
| Change from Baseline feces indicators at one day post intervention | placed at -80°C for assay within 6 months. | Assessed at baseline, one day post intervention |
| Change from Baseline The motor part of the Unified Parkinson's Disease Rating Scale at one day post intervention | The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome. | Assessed at baseline, one day post intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |