RecruitingNot Applicable

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

China12 participantsStarted 2024-12-23

Plain-language summary

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.

Who can participate

Age range55 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 55-75 years.
✓. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
✓. Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation.
✓. Parkinson's disease duration ≤ 3 years.
✓. Receiving standard anti-Parkinson's disease medication treatment.

Exclusion criteria

✕. Patients with cognitive impairment (MMSE \< 24 and/or MoCA \< 26) or mental illnesses, or those unable to cooperate for other reasons.
✕. Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01.
✕. Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.
✕. Previous treatment with vagus nerve stimulation.
✕. MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts \> 1 cm³ or \> 3 lacunar infarcts.
✕. Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation.
✕. Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related.
✕. Previous history of stroke or intracranial mass lesions.

What they're measuring

MDS-UPDRS-Ⅲ

Timeframe: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days

Free water in the posterior substantia nigra (DTI)

Timeframe: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days

Trial details

NCT IDNCT06665113

SponsorKezhong Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Kezhong Zhang, Professor

400-13770840575 kezhong_zhang1969@126.com

View on ClinicalTrials.gov More Parkinson Disease, Idiopathic trials