Parkinson Disease
Conditions
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.
Interventions
DEVICEActive taVNS
Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
DEVICESham 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | Baseline (Visit 1) to Day 14 (Visit 10) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function Score | Screening to Day 13 (Visit 9) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active taVNS Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus | 17 |
| Sham Stimulation 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. | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | Sham Stimulation | Total | Active taVNS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 20 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 13 Participants | 8 Participants |
| Race/Ethnicity, Customized White/Caucasian | 16 Participants | 33 Participants | 17 Participants |
| Region of Enrollment United States | 16 participants | 33 participants | 17 participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 18 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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
Time frame: Baseline (Visit 1) to Day 14 (Visit 10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active taVNS | Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 0.72 score on a scale | Standard Deviation 0.85 |
| Sham Stimulation | Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III | 0.01 score on a scale | Standard Deviation 1.02 |
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.
Time frame: Screening to Day 13 (Visit 9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active taVNS | Change in Cognitive Function Score | -3.35 score on a scale | Standard Deviation 2.58 |
| Sham Stimulation | Change in Cognitive Function Score | 5.12 score on a scale | Standard Deviation 2.59 |
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.
Time frame: Screening to Day 13 (Visit 9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active taVNS | Change in Cognitive Function Score | 1.25 score on a scale | Standard Deviation 0.6 |
| Sham Stimulation | Change in Cognitive Function Score | -0.22 score on a scale | Standard Deviation 0.83 |
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.
Time frame: Screening to Day 13 (Visit 9)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active taVNS | Change in Cognitive Function Score | 0.19 score on a scale | Standard Deviation 0.3 |
| Sham Stimulation | Change in Cognitive Function Score | 0.70 score on a scale | Standard Deviation 0.44 |