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Efficacy and safety of vagus nerve stimulation in the treatment of Parkinson's disease: a prospective, self-controlled clinical study

Efficacy and safety of vagus nerve stimulation in the treatment of Parkinson's disease: a prospective, self-controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070828
Enrollment
Unknown
Registered
2023-04-24
Start date
2023-04-30
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

Treatment group:Transcutaneous auricular vagus nerve stimulation for 14 days
control group:Transcutaneous forearm electrical stimulation for 14 days

Sponsors

Binzhou Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Male or female, age >30 years, <=75 years; (2) Meet the "Diagnostic Criteria for Parkinson's Disease" developed by the International Movement Disorders Society (MDS) in 2015; (3) Patients with early onset Parkinson's disease, <5 years of duration, Hoehn-Yahr grade 1-3; (4)The subjects who received a stable dose of Madopar, dopamine receptor agonists or monoamine oxidase type B inhibitors for one month before study enrollment (5) Signed informed consent form. Translated with www.DeepL.com/Translator (free version)

Exclusion criteria

Exclusion criteria: (1) Patients with disorders of consciousness, aphasia and psychiatric disorders. Patients with major depression; (2) Patients with Parkinson's superposition syndrome and patients with secondary Parkinson's syndrome (hepatomegaly, hepatic encephalopathy, cerebellar disease, hydrocephalus, parathyroid disease, etc.); (3) Patients with long-term use of dopamine blockers (e.g., potent neuroleptics, Cipro, reserpine, metoclopramide, etc.) (4) Patients who have had a transient ischemic attack within six months (5) A history of 2 or more strokes or post-stroke sequelae within 6 months prior to enrollment; (6) Those with PD treated by stereotactic brain surgery; (7) Patients with severe cardiopulmonary instability, hepatic and renal insufficiency, and other diseases (greater than 3 times the normal value) (8) Patients who cannot cooperate with neuropsychological testing (9) Those who do not follow the prescribed treatment regimen and have poor compliance; (10) Patients deemed unsuitable for enrollment by the investigator

Design outcomes

Primary

MeasureTime frame
mds unified-parkinson disease rating scale-?;

Secondary

MeasureTime frame
Hoehn-Yahr;mini-mental state examiniation;Patient Assessment of Constipation symptom ,PAC-SYM;Hamilton Anxiety Scale,HAMA;Hamilton depression scale,HAMD;Parkinson's Disease Questionnaire (PDQ-39);the Parkinson's Disease Sleep Scale 2 (PDSS-2);Fatigue Scale-14;scale for outcomes in PD for autonomic symptoms(SCOPA-AUT);

Countries

China

Contacts

Public ContactHongcai Wang

Department of Neurology, Binzhou Medical University Hospital

whc2891@126.com+86 13954335445

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026