Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Sleep Disorders of PD

NCT05806736 | Completed

• 1 other identifier: 2022-SR-519
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a double-blind comparative study examining the curative effect and mechanism of the transcutaneous auricular vagus nerve stimulation treatment on non-motor symptoms of Parkinson's disease patients. The investigators hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve the non-motor symptoms, such as improving sleep, and improve cortical activity simultaneously in Parkinson's disease patients.

Conditions

Parkinson Disease

Keywords

non-motor symptoms; Therapeutics; nighttime insomnia

Outcome Measures

Primary Outcomes (1)

• Changes in sleep quality, sleep efficiency of patients

  Pittsburgh sleep quality index (PSQI) was used to evaluate the sleep quality of participants in the past month. It consists of 19 self-evaluation and 5 other evaluation items. The total score range is 0-21, with higher scores indicating poorer sleep quality.

  Assessed at baseline, one day post intervention, fourteen days post intervention.

Secondary Outcomes (11)

• The motor part of the Unified Parkinson's Disease Rating Scale

  Assessed at baseline, one day post intervention, fourteen days post intervention.

• Changes of sleep quality scale

  Assessed at baseline, one day post intervention, fourteen days post intervention.

• Changes of Rapid-eye-movement Sleep Behavior Disorder scale

  Assessed at baseline, one day post intervention, fourteen days post intervention.

• Epworth sleepiness scale (ESS)

  Assessed at baseline, one day post intervention.

• Hamilton Depression Scale-24 (HAMD-24)

  Assessed at baseline, one day post intervention.

Study Arms (2)

active transcutaneous auricular vagus nerve stimulatio

EXPERIMENTAL

For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent fourteen consecutive daily sessions of taVNS.

Device: Transcutaneous auricular vagus nerve stimulation (real stimulation)

sham transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent fourteen consecutive daily sessions of sham-taVNS (the electrodes were fixed at the left earlobe with the same stimulation parameters).

Device: Transcutaneous auricular vagus nerve stimulation (sham stimulation)

Interventions

Transcutaneous auricular vagus nerve stimulation (real stimulation) DEVICE

Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time.

active transcutaneous auricular vagus nerve stimulatio

Transcutaneous auricular vagus nerve stimulation (sham stimulation) DEVICE

Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs, twice a day, 30 minutes each time.

sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) right-handed individuals aged 45-80 years; (ii) met the diagnostic criteria for idiopathic PD and had been stable on medication for at least one month; (iii) met the diagnostic criteria for insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and insomnia had to have lasted for at least six months, with Pittsburgh sleep quality index (PSQI) scores \>7; (iv) no history of medication that might affect the study, such as sleeping pills or antidepressants, that is, the PSQI hypnotic medication score of 0; (v) clear consciousness, basic communication skills and cooperation in all assessments and treatments; (vi) The patients agreed to participate in the study and signed an informed consent form.

You may not qualify if:

• (i) those with concomitant cognitive dysfunction, such as Montreal cognitive assessment (MoCA) \<23; (ii) those with secondary Parkinson's syndrome or Parkinson's superimposed syndrome; (iii) those with severe cardiac, pulmonary, hepatic, renal, or concomitant malignancies or a history of previous brain surgery; (iv) those with contraindications to taVNS interventions; (v) those with severe psychiatric disorders; (vi) Insomnia not caused by PD, such as frequent (two times per week) nighttime use of sedative medications (including sedative antidepressants), untreated restless legs syndrome, night-shift work or other occupations that result in abnormal sleep patterns, insomnia associated with dopamine therapy, and other reversible causes of insomnia identified by the baseline clinical interview.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kezhong Zhang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor/Chief physician

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 10, 2023
• Study Start: September 1, 2022
• Primary Completion: August 8, 2023
• Study Completion: December 31, 2023
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)