taVNS in Mild to Moderate Parkinson's Disease (taVNS)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active taVNS
Sham Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active taVNS
Sham Stimulation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04157621
First Posted
September 9, 2019
Last Updated
January 5, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT04157621
Brief Title
taVNS in Mild to Moderate Parkinson's Disease
Acronym
taVNS
Official Title
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active taVNS
Arm Type
Active Comparator
Arm Title
Sham Stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active taVNS
Intervention Description
Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Description
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
Time Frame
Baseline (Visit 1) to Day 14 (Visit 10)
Secondary Outcome Measure Information:
Title
Change in Cognitive Function Score
Description
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.
Time Frame
Screening to Day 13 (Visit 9)
Title
Change in Cognitive Function Score
Description
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.
Time Frame
Screening to Day 13 (Visit 9)
Title
Change in Cognitive Function Score
Description
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.
Time Frame
Screening to Day 13 (Visit 9)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Hinson, MD, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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taVNS in Mild to Moderate Parkinson's Disease
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