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

NCT06623591 | Not Yet Recruiting DMC

• 1 other identifier: 2024-taVNS
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease, Idiopathic; Constipation

Keywords

constipation; Parkinson's disease

Outcome Measures

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.

  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

  Assessed at baseline, one day post intervention

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

  Assessed at baseline, one day post intervention

• Change from Baseline constipation symptoms scores at one day post intervention

  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

  Assessed at baseline, one day post intervention

• Change from Baseline Patient Assessment of Constipation Symptoms questionnaire at one day post intervention

  Assessed at baseline, one day post intervention

Study Arms (2)

Active Transcutaneous auricular vagus nerve stimulation

EXPERIMENTAL

For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 28 consecutive daily sessions of taVNS.

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).

Device: sham Transcutaneous auricular vagus nerve stimulation

Interventions

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.

Active Transcutaneous auricular vagus nerve stimulation

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.

Sham Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kezhong Zhang: lead

MeSH Terms

Conditions

Parkinson Disease; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kezhong Zhang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kezhong Zhang, Professor

CONTACT

13770840575; kezhong_zhang1969@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share