The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Depression in PD

ConditionParkinson Disease

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40-80

SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with depression. The investigators hypothesize that taVNS will improve depression and cortical activity in Parkinson's disease patients with depression.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

Active Transcutaneous auricular vagus nerve stimulation
Device
Active Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.Sham Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. The stimulation paradigm was identical to that of the real stimulation group. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
Sham Transcutaneous auricular vagus nerve stimulation
Device
Two modified dot-like electrodes delivered the stimulation to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min. Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: real Transcutaneous auricular vagus nerve stimulationActive comparator 1 intervention

Group B: Sham Transcutaneous auricular vagus nerve stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

change of Hamilton Depression Scale Score

Hamilton Depression Scale (HAM-D score), which was used for assessing the degree of Depression.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment

Time frame

Assessed at baseline, one day post intervention,2 weeks post intervention

change of Hamilton Depression Scale Score Hamilton Anxiety Scale (HAM-D score), which was used for assessing the degree of anxiety.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment

Time frame

Assessed at baseline, one day post intervention#2 weeks post intervention

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

The Second People's Hospital of Huai'an

Collaborator

Source ClinicalTrials.gov

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