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

The First Affiliated Hospital with Nanjing Medical University30 enrolled

Overview

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.

Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time), whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of motor and non-motor symptoms, cortical activity (using Functional near-infrared spectroscopy) and blood indicators were performed three times: at baseline, one day post intervention, fourteen days post intervention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

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.

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: (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. Exclusion Criteria: (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.

Locations (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.

Secondary Outcomes

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

The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome.

Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.

Changes of sleep quality scale

Non-motor symptoms such as sleep disorders were evaluated by Parkinson's disease sleep scale-2 (PDSS-2). PDSS-2 is an improved version of PDSS used to screen for common types of sleep disorders in Parkinson's disease patients. The minimum and maximum values of the non-motor part of the PDSS-2 Scale are 0 and 60. A higher score means a worse outcome.

Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.

Changes of Rapid-eye-movement Sleep Behavior Disorder scale

Rapid-eye-movement Sleep Behavior Disorder Screening Questionnaire (RBDSQ) was used to assess the behavior disorder of multiple eye movement sleep. The minimum and maximum values of the non-motor part of the RBDSQ Scale are 0 and 13. A higher score means a worse outcome.

Time frame: Assessed at baseline, one day post intervention, fourteen days post intervention.

Epworth sleepiness scale (ESS)

The Epworth Sleepiness Scale, also known as the Epworth Daytime Sleepiness Scale, was developed by Johns MW to assess excessive daytime sleepiness. This scale has clinical significance: it can provide a semi-objective assessment of sleepiness. Scoring more than 6 out of 24 indicates drowsiness, more than 11 indicates excessive sleepiness, and more than 16 indicates dangerous sleepiness.

Data from ClinicalTrials.gov

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