Parkinson Disease, IdiopathicNCT06623591
Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.
A study testing active Transcutaneous auricular vagus nerve stimulation in people with Parkinson Disease, Idiopathic and Constipation, run by Kezhong Zhang.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic, Constipation
- What is being tested?
- active Transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease, Idiopathic, Constipation
- Being tested
- active Transcutaneous auricular vagus nerve stimulation, sham Transcutaneous auricular vagus nerve stimulation
- Keywords
- constipation, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active Transcutaneous auricular vagus nerve stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Transcutaneous auricular vagus nerve stimulation | Experimental | For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 28 consecutive daily sessions of taVNS. Receives: Device: active Transcutaneous auricular vagus nerve stimulation |
| 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). Receives: Device: sham Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at 2 weeks before baseline, 2 weeks before the last day of intervention
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at baseline, one day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kezhong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623591
- Sponsor's protocol ID
- 2024-taVNS
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06623591
- Acronym / sponsor ID
- 2024-taVNS
- Conditions
- Parkinson Disease, Idiopathic, Constipation
- Keywords
- constipation, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kezhong ZhangUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcutaneous auricular vagus nerve stimulation | Experimental | Device: active Transcutaneous auricular vagus nerve stimulationFor Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 28 consecutive daily sessions of taVNS. |
| Sham Transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: sham Transcutaneous auricular vagus nerve stimulationFor 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active Transcutaneous auricular vagus nerve stimulationTranscutaneous 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 | Active Transcutaneous auricular vagus nerve stimulation |
| sham Transcutaneous auricular vagus nerve stimulationIn 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. | Device | Sham Transcutaneous auricular vagus nerve stimulation |
Primary outcome
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
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.
15 secondary outcomes
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
Change from Baseline serum indicators at one day post intervention
Time frame: Assessed at baseline, one day post intervention
Change from Baseline feces indicators at one day post intervention
Time frame: 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
Time frame: Assessed at baseline, one day post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kezhong Zhang principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing active Transcutaneous auricular vagus nerve stimulation in people with Parkinson Disease, Idiopathic and Constipation, run by Kezhong Zhang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kezhong Zhang, Professor (13770840575, kezhong_zhang1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.