Study of Long-term Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Effects in Early Parkinson's Disease Patients A Double-blind Randomized Controlled Trial

What this Trial Is About

Researchers are exploring the effects of long-term transcutaneous auricular vagus nerve stimulation (taVNS) in patients with early-stage Parkinson's disease. This randomized, double-blind, controlled trial aims to investigate whether this novel treatment approach can help delay the progression of Parkinson's disease in adults aged 55 to 75 years who have been diagnosed according to established Chinese diagnostic criteria and are at an early stage of the disease. Participants are randomly assigned to one of two groups: a real stimulation group or a sham stimulation group. The real stimulation involves applying electrical pulses through modified electrodes near the auricular branch of the vagus nerve in the left ear, with parameters set at 20 Hz frequency and 500 microseconds pulse width, delivered in cycles of 60 seconds on and 10 seconds off for a total of 30 minutes. The sham group receives similar stimulation on the earlobes without targeting the vagus nerve. Both groups undergo this intervention consistently over the study period. During the study, participants are assessed multiple times at baseline, 180 days, 360 days, 540 days, and 570 days. The evaluations include clinical measures such as the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II (MDS-UPDRS-II) and brain imaging techniques like diffusion tensor imaging to measure free water in a specific brain region affected by Parkinson's. These assessments help researchers monitor disease progression and potential neuroprotective effects of the taVNS treatment. Safety and adherence to the treatment are also closely followed throughout the trial.

Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients