Trials / Not Yet Recruiting
Not Yet RecruitingNCT06623591
Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.
Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson's Disease Patients: a Randomized, Double-blind Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Kezhong Zhang · Academic / Other
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| 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. |
Timeline
- Start date
- 2024-10-15
- Primary completion
- 2024-11-30
- Completion
- 2024-12-30
- First posted
- 2024-10-02
- Last updated
- 2024-10-04
Source: ClinicalTrials.gov record NCT06623591. Inclusion in this directory is not an endorsement.