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

Kezhong Zhang

Status: Not yet enrolling

Conditions: Constipation; Parkinson Disease, Idiopathic

Treatments: Device: sham Transcutaneous auricular vagus nerve stimulation; Device: active Transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06623591

2024-taVNS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

Active Transcutaneous auricular vagus nerve stimulation

Experimental group

Description:

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

Treatment:

Device: active Transcutaneous auricular vagus nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

Sham Comparator group

Description:

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).

Treatment:

Device: sham Transcutaneous auricular vagus nerve stimulation