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

NCT ID: NCT06623591

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2024-12-30

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.

Conditions

Parkinson Disease, Idiopathic; Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Transcutaneous auricular vagus nerve stimulation

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

Group Type: EXPERIMENTAL

active Transcutaneous auricular vagus nerve stimulation

Intervention Type: 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.

Sham Transcutaneous auricular vagus nerve stimulation

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).

Group Type: SHAM_COMPARATOR

sham Transcutaneous auricular vagus nerve stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kezhong Zhang

OTHER

Sponsor Role: lead

Responsible Party

Kezhong Zhang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kezhong Zhang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Kezhong Zhang, Professor

Role: CONTACT

kezhong_zhang1969@126.com

13770840575

Other Identifiers

2024-taVNS

Identifier Type: -

Identifier Source: org_study_id