- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05806736
Curative Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Non-motor Symptoms of PD
Study on the Efficacy and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in the Treatment of Non-motor Symptoms of Parkinson's Disease
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jiang Su
-
Nanjing, Jiang Su, China, 210029
- Recruiting
- The First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- PDSS score<82 (or a subscore<5).
- Age between 40 and 80 years old.
- Mini-Mental State Examination score >24.
- Right-handed patient.
- Stable medication.
Exclusion Criteria:
- Clinically diagnosed as other Parkinson's syndrome.
- Cognitive impairment (MMSE<24), severe anxiety and depression, epilepsy history, severe diabetes, organic brain stem injury (such as stroke, tumor, demyelinating disease, etc.).
- Taking anticholinergic drugs.
- Taking antipsychotic drugs.
- There are contraindications to taVNS stimulation, such as implantation of a cardiac pacemaker after DBS operation, patients with local infection or loss of an ear, or metal implants at the stimulation site.
- There is uncontrolled hypertension, coronary heart disease, or recent acute myocardial infarction.
- Patients who cannot complete follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: active transcutaneous auricular vagus nerve stimulatio
For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent fourteen consecutive daily sessions of taVNS.
|
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.
|
Sham Comparator: sham transcutaneous auricular vagus nerve stimulation
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of non-motor symptom scale
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Non-motor symptoms such as sleep disorders were evaluated by Parkinson's disease sleep scale (PDSS).
The minimum and maximum values of the non-motor part of the PDSS Scale are 0 and 150.
A lower score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes of sleep quality scale
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
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.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes of Rapid-eye-movement Sleep Behavior Disorder scale
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
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.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting motor threshold (RMT)
Time Frame: Assessed at baseline, one day post intervention.
|
RMT (% TMS output intensity) is defined as the lowest intensity required to elicit MEPs of > 50 μV in at least 5 of 10 consecutive trials while the target muscle is relaxed.
RMT was determined to be the nearest 1% of the maximum stimulator output.
|
Assessed at baseline, one day post intervention.
|
Cortical silent period (CSP)
Time Frame: Assessed at baseline, one day post intervention.
|
The CSP (ms) is measured through electromyographic signal recording (EMG) on a target muscle and refers to the period of EMG silence following the elicitation of a motor-evoked potential (MEP) through a single TMS pulse delivered over the contralateral primary motor cortex. Individuals were asked to actively contract abductor pollicis brevis (APB) with 20% of the maximum force, while a single pulse with 150% of RMT was applied to the opposite primary motor cortex. We recorded the time from pulse outputting to the recovery of inhibited active contraction as CSP. The above protocol was repeated ten times, and the average value of CSP was calculated. |
Assessed at baseline, one day post intervention.
|
Intracortical facilitation (ICF)
Time Frame: Assessed at baseline, one day post intervention.
|
ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 15 ms interstimulus interval between conditioning and test stimuli.
Ten trials were acquired for each interstimulus interval.
ICF was expressed as the percentage ratio between the test and conditioning MEP.
|
Assessed at baseline, one day post intervention.
|
Changes in ΔHbO2 concentration in the brain cortex
Time Frame: Assessed at baseline, one day post intervention.
|
The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
|
Assessed at baseline, one day post intervention.
|
The motor part of the Unified Parkinson's Disease Rating Scale
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
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.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Serological indicators
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
5ml of the patient's elbow vein blood was collected and centrifuged after standing and stratified.
The serum was collected and frozen at - 20 ℃ for testing.
Detection of inflammatory factors indicators.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Short interval intracortical inhibition (SICI)
Time Frame: Assessed at baseline, one day post intervention.
|
SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with a 4ms interstimulus interval between conditioning and test stimuli.
Ten trials were acquired for each interstimulus interval.
SICI was expressed as the percentage ratio between the test and conditioning MEP.
|
Assessed at baseline, one day post intervention.
|
Changes in the cognitive changes
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The changes of patients' cognition were evaluated with mini-mental state examination (MMSE) scales.
The minimum and maximum values of the non-motor part of the MMSE Scale are 0 and 30.
The test scores are closely related to cultural level, and the normal threshold classification criteria are: illiteracy>17 points, primary school>20 points, and middle school and above>24 points.
Below the boundary value, there is a cognitive impairment, while above is normal.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Change of anxiety level of patients
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The anxiety level of patients was assessed with Hamilton anxiety scale (HAMA) scale.
The minimum and maximum values of the non-motor part of the HAMA Scale are 0 and 56.
A higher score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in depression level of patients
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The change of patients' depression level was evaluated with Hamilton Depression Scale 24 (HAMD-24) scale.
The minimum and maximum values of the non-motor part of the HAMD Scale are 0 and 96.
A higher score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in sleep quality, sleep efficiency and other sleep indicators of patients
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The changes of patients' sleep quality, sleep efficiency and other sleep indicators were evaluated with Epworth Sleepiness Scale (ESS) scales.
ESS scale used to evaluate daytime drowsiness.
The minimum and maximum values of the non-motor part of the ESS Scale are 0 and 24.
A higher score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in patients' fatigue
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The fatigue degree of patients was evaluated with Fatigue Severity Scale (FSS) scale.
The minimum and maximum values of the non-motor part of the FSS Scale are 7 and 63.
A higher score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in patients' anxiety level
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The change of patients' anxiety was evaluated with apathy scale (AS) scale.
The minimum and maximum values of the non-motor part of the AS Scale are 0 and 27.
A higher score means a worse outcome.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in the cognitive degree
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
The change of cognitive degree of patients was evaluated with Montreal Cognitive Assessment (MoCA) scale.
The total score of the MoCA scale is 30, generally 26 points or higher is considered normal, between 18-26 points is considered mild cognitive impairment, between 10-17 points is moderate cognitive impairment, and less than 10 points is severe cognitive impairment.
If the assessed person has less than or equal to 12 years of education, they are generally only at the high school level, and the result can be increased by 1 point, but the total score cannot exceed 30 points.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Plasma indicators
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
5ml of the patient's elbow vein blood was collected and centrifuged after standing and stratified.
The blood plasma was collected and frozen at - 20 ℃ for testing.
Detection of changes in plasma ghrelin levels.
|
Assessed at baseline, one day post intervention, fourteen days post intervention.
|
Changes in sleep quality, sleep efficiency of patients
Time Frame: Assessed at baseline, one day post intervention, fourteen days post intervention.
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-SR-519
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Transcutaneous auricular vagus nerve stimulation (real stimulation)
-
Jiani WuNot yet recruiting
-
Nanfang Hospital, Southern Medical UniversityBrainClos Co., LTD.; Zhuhai Fudan Innovation InstituteNot yet recruitingCluster Headache | Migraine in Children | Tension Headache | Migraine in Adolescence | Primary HeadacheChina
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruitingParkinson DiseaseChina
-
Sahlgrenska University Hospital, SwedenRecruitingBorderline Personality DisorderSweden
-
Guang'anmen Hospital of China Academy of Chinese...China Association for Science and TechnologyRecruiting
-
University Hospital TuebingenUniversität TübingenCompleted
-
Massachusetts General HospitalBrain & Behavior Research FoundationCompletedMajor Depressive DisorderUnited States
-
Medical University of South CarolinaRecruiting
-
Istanbul Physical Medicine Rehabilitation Training...RecruitingHemiplegia | Stroke, Ischemic | Hemiparesis;Poststroke/CVATurkey
-
Burrell College of Osteopathic MedicineRecruitingPsoriasis VulgarisUnited States