Parkinson's disease
Conditions
Interventions
Real Stimulation group:Transcutaneous auricular vagus nerve stimulation (20HZ) for the earnail cavity and oculus part of the ear nail
Sham Stimulation group:Transcutaneous auricular vagus nerve stimulation (20HZ) at the ear rim
Healthy control group:none
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age between 40~80 years old; (2) PD patients with typical PD core motor symptoms were clinically diagnosed as primary PD by two experienced neurologists according to the 2015 international standards; (3) Stable use of anti-PD drugs, stable disease control, no drug adjustment plan in the past 2 months; (4) Hoehn&Yahr grading score between 1 and 3; (5) Junior high school education or above, basic normal intelligence, no obvious cognitive impairment using MMSE testing, can cooperate with clinical symptom assessment, fMRI, electroencephalogram and blood index examination; (6) Those who voluntarily participate in the trial and sign the informed consent form. Note: Only patients who meet the above 6 conditions at the same time can be included in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with secondary PD, severe PD (Hoehn & Yahr score above 3 points) or PD superposition syndrome under clinical consideration; (2) Patients with serious primary diseases such as heart, liver, kidney, blood system and other neurological diseases; (3) Patients with unstable medication control for PD and are likely to need to adjust the treatment drugs during the treatment period; (4) Patients with a history of alcohol or drug abuse, schizophrenia or other serious mental illness; (5) Those who have contraindications to MRI and cannot complete the MRI examination (there are implanted metals in the body, including pacemakers, metal joints, etc., claustrophobia). (6) Patients with severe cognitive impairment or personality disorder or severe suicidal ideation or suicidal behavior; (7) Those who have used acupuncture, moxibustion and other traditional Chinese medicine and other physiotherapy within the scope of traditional medicine within 14 days; (8) Diabetes, malignant tumors and other serious wasting diseases; (9) Those who suffer from notifiable infectious diseases, such as HIV, etc., and are not suitable for acupuncture intervention; (10) Lack of autonomy, limited mobility, and inability to participate in the 2-month follow-up; (11) Patients who plan to become pregnant, pregnant and lactating; (12) Those who are allergic to skin contact; (13) Those with severe skin lesions in the ear nail area and absent auricular plaques; (14) Those who participate in other clinical trials at the same time Note: Any of the above conditions will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDS Unified-Parkinson Disease Rating Scale III;The Parkinson's Disease Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS Unified-Parkinson Disease Rating Scale II;Hoehn-Yahr Scale;Purdue Pegboard Test;Timed-up-and-go;10m Walk Test;Berg Balance Scale;Minimum Mental State Examination;Montreal Cognitive Assessment-Basic;Nonmotor Symptoms Scale;Hamilton Depression Rating Scale-17;Parkinson's Anxiety Scale?;Parkinson's disease sleep scale;Epworth Sleepiness Scale;REM Sleep Behavior Disorder Questionnaire-HK;Fatigue Severity Scale;The Gastrointestinal Dysfunction Scale in Parkinson’S Disease;Patient Assessment of Constipation symptom; | — |
Countries
China
Contacts
Public ContactJiliang Fang
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed