Parkinson Disease
Conditions
Keywords
Parkinson's disease, Anxiety, taVNS
Brief summary
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 anxiety. The investigators hypothesize that taVNS will improve anxiety and cortical activity in Parkinson's disease patients with anxiety.
Detailed description
Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of anxiety symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention. The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post intervention.
Interventions
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.
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* (1) diagnosed with idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD; * (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for anxiety and Hamilton Anxiety Scale (HAMA) score ≥ 12; * (3) stable pharmacotherapy for PD at least one month prior to the study; * (4) 40-80 years old; * (5) willing to sign written informed consent.
Exclusion criteria
* (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) \< 23; * (2) took antianxiety drugs; * (3) with taVNS contraindications; * (4) received VNS treatment during the past month; * (5) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of Hamilton Anxiety Scale Score | Assessed at baseline, one day post intervention，2 weeks post intervention | Hamilton Anxiety Scale (HAM-A score), which was used for assessing the degree of anxiety. It consists of 14 symptomatic definition elements, with a total possible score of 56. The differences in HAMA score before and after treatment can be used to evaluate the effect of taVNS treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of HbO2 in the prefrontal cortex | Assessed at baseline, one day post intervention | The change of HbO2 in the prefrontal cortex is accessed by fNIRS combined with verbal fluency task. Recent documents have highlighted the effectiveness of fNIRS combined with verbal fluency task (VFT) in detecting alterations in the PFC in patients with anxiety. The differences in HbO2 before and after treatment can be used to evaluate the effect of taVNS treatment. |
| change of Unified Parkinson's Disease Rating Scale Score section III | Assessed at baseline, one day post intervention，2 weeks post intervention | Unified Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms. |
| change of Unified Parkinson's Disease Rating Scale Score section I | Assessed at baseline, one day post intervention，2 weeks post intervention | Unified Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions) |
Countries
China
Contacts
Primary ContactZhang Kezhong
Backup ContactZhang Kezhong, Study Principal Investigator
Outcome results
None listed