Trial Outcomes & Findings for taVNS in Mild to Moderate Parkinson's Disease (NCT NCT04157621)
NCT ID: NCT04157621
Last Updated: 2023-01-25
Results Overview
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
COMPLETED
NA
33 participants
Baseline (Visit 1) to Day 14 (Visit 10)
2023-01-25
Participant Flow
Participant milestones
| Measure |
Active taVNS
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
taVNS in Mild to Moderate Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Active taVNS
n=17 Participants
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
Sham Stimulation
n=16 Participants
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.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Active taVNS
n=15 Participants
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
Sham Stimulation
n=15 Participants
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.
|
|---|---|---|
|
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
|
0.01 score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Active taVNS
n=15 Participants
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
Sham Stimulation
n=15 Participants
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.
|
|---|---|---|
|
Change in Cognitive Function Score
|
-3.35 score on a scale
Standard Deviation 2.58
|
5.12 score on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Screening to Day 13 (Visit 9)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.
Outcome measures
| Measure |
Active taVNS
n=15 Participants
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
Sham Stimulation
n=15 Participants
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.
|
|---|---|---|
|
Change in Cognitive Function Score
|
1.25 score on a scale
Standard Deviation 0.60
|
-0.22 score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Screening to Day 13 (Visit 9)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.
Outcome measures
| Measure |
Active taVNS
n=15 Participants
Active taVNS: Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
|
Sham Stimulation
n=15 Participants
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.
|
|---|---|---|
|
Change in Cognitive Function Score
|
0.19 score on a scale
Standard Deviation 0.30
|
0.70 score on a scale
Standard Deviation 0.44
|
Adverse Events
Active taVNS
Sham Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place