This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.
This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease, , aiming to investigate a novel therapeutic approach for delaying PD progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.
For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGMDS-UPDRS-Ⅲ
Used to evaluate the motor function.
Time frame: baseline, 180±7 days, 360±7 days, 540±7 days,570±7 days
Free water in the posterior substantia nigra (DTI)
Used to measure progression of early Parkinson's disease.
Time frame: baseline, 180±7 days, 360±7 days, 540±7 days,570±7 days
Scales: MDS-UPDRS-II
Used to evaluate quality of life of PD.
Time frame: baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days,570±7 days
Step Length、Stride Length、Stride Velocity and Step Length Variability
Used to assess the patient's gait disturbances,including the Step Length、Stride Length、Stride Velocity and Step Length Variability
Time frame: baseline,180±7 days, 360±7 days, 540±7 days,570±7 days
Scales: H&Y stage
Used to evaluate the stage of PD.
Time frame: baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days,570±7 days
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