taVNS in Mild to Moderate Parkinson's Disease

Parkinson Disease Clinical Trial

— taVNS  

Official title:

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157621
• Other study ID #: 00073767
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: January 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age: 40-79 y

• Idiopathic Parkinson's Disease Diagnosis

• Disease Stage: Hoehn and Yahr stage 2-3

• Patient requires a minimum of 3 doses of levodopa daily

• Willingness to be videotaped

Exclusion criteria:

• Dementia or Montreal Cognitive Assessment score <24

• Parkinson's Disease psychosis

• Ear trauma

• Facial pain

• Traumatic Brain Injury or clinical history of stroke

• Metal implants above the shoulders

• History of myocardial infarction or arrhythmia, bradycardia

• Active respiratory disorder

• Alcohol or substance use disorders

• History of Deep Brain Stimulation (DBS) or other brain surgery

• Epilepsy

• Pregnancy

• B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Active taVNS
Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
• Sham Stimulation
Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	The MDS-UPDRS is a rating scale used in research and clinic to rate the severity of Parkinson's Disease. A low score indicates mild disease and a high score more advanced disease. The possible range for MDS-UPDRS Part III is 0-132. Higher scores reflect greater motor disturbance. A decline in score from pre-post would indicate improvement. This outcome observed Part III of UPDRS motor examination.; Information on cover page: The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). Part I has two components: IA concerns a number of behaviors that are assessed by the investigator with all pertinent information from patients and caregivers, and IB is completed by the patient with or without the aid of the caregiver, but independently of the investigator. These sections can, however, be reviewed by the rater to ensure that all questions are answered clea	Baseline (Visit 1) to Day 14 (Visit 10)
Secondary	Change in Cognitive Function Score	Delis-Kaplan Executive Function System (DKEFS) letter fluency is an investigator administered test that assesses verbal fluency. Higher scores indicate more correct responses. A positive value of change means an improvement in fluency. A decrease in score represents decrease in fluency. The minimum score is 0 and there is no maximum score. The raw score is total from letters F, A, and S.	Screening to Day 13 (Visit 9)
Secondary	Change in Cognitive Function Score	DKEFS category fluency is an investigator administered test checking into ability to switch between categories presented. There is no upper limit on the D-KEFS measures. There is no lower limit on the D-KEPS measure. Higher scores reflect better verbal fluency. An increase in score from pre-post would indicate improvement. Decrease in value represents decrease in fluency. Raw score is total of Animals + Boys Names.	Screening to Day 13 (Visit 9)
Secondary	Change in Cognitive Function Score	Digit span forward is an investigator administered test looking at attention. The possible range for Digit Span Forward is 0-16, same for Digit Span Backward. Higher scores reflect better focused attention and working memory. An increase in score from pre-post would indicate improvement.	Screening to Day 13 (Visit 9)