N/A
N=22
Combining VNS With PT Interventions for Individuals With PD
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT05871151 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III — 31.00; 36.70; 25.1; 26.8 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- taVNS (Device); Exercise (Behavioral)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III |
31.00; 36.70; 25.1; 26.8; 24.5; 32.3 | — |
| PRIMARY Six Minute Walk Test (6MWT) |
1411.94; 1366; 1566; 1448.111111; 1544; 1435 | — |
| PRIMARY Ten Meter Walk Test (10MWT) |
5.022333333; 5.101666667; 5.021333333; 5.309333333; 5.103; 5.238 | — |
| PRIMARY Mini-Best Test |
22.3; 20.9; 25.7; 22.8; 25.8; 22.2 | — |
| PRIMARY Functional Gait Assessment (FGA) |
25; 22.7; 28.6; 24.4; 27.6; 24 | — |
| PRIMARY mCTSIB |
226; 182.2; 217.4; 175.6; 197.6; 197.1 | — |
| SECONDARY MoCA |
27.2; 26.7; 28; 26.7; 27.7; 27.9 | — |
| SECONDARY DKEFS Color Word Interference Test - Condition One |
8.888888889; 9.2; 10.3; 8.888888889; 10.6; 8 | — |
| SECONDARY DKEFS Color Word Interference Test - Condition Two |
9.8; 9.111111111; 10.6; 8.444444444; 10.7; 8.125 | — |
| SECONDARY DKEFS Color Word Interference - Condition Three |
10.5; 9.666666667; 11.1; 8.333333333; 11.3; 9.625 | — |
| SECONDARY DKEFS Verbal Fluency Test |
12.9; 9.1; 12.6; 8.6; 12.9; 9.4 | — |
| SECONDARY Digit Span Test |
10.44444444; 9.7; 10.66666667; 9.777777778; 11.33333333; 11.33333333 | — |
| SECONDARY Digit Symbol Substitution Test |
37.1; 39.2; 41.1; 38.9; 39.4; 40.7 | — |
| SECONDARY Flanker |
95.75; 99.25; 102.75; 95.375; 103.5; 102.375 | — |
| SECONDARY Promise Neuro-QOL (Ability) |
47.89; 52.97; 49.71; 48.33; 48.95; 48.66 | — |
| SECONDARY SF-36 |
67.26388889; 72.01388889; 69.31944445; 71; 69.06944446; 73.4722222 | — |
Summary
The purpose of this study is to evaluate the combined effects of non-invasive neuromodulation (specifically transauricular Vagus Nerve Stimulation) with exercise interventions to improve physical function and quality of life in individuals with Parkinsons Disease.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of PD by a board-certified neurologist
- age between 35 and 80 years
- no walking aids
- stable medication 4 weeks prior to and during the study
- no falls in the past 6 months
- participant must have MD who is willing to provide oversight and approval for clinically defined OFF state
Exclusion Criteria
- mild cognitive impairment (MoCA <25)
- self reported depression
- antidepressive or antipsychotic medication
- participation in a VNS study in the past year
- disabling bradykinesia to ensure patients are able to participate in intensive physiotherapy (based on clinical impression and in accordance to UPDRS part III item 14 - to be administered in clinic)
- prior history of cardiovascular, neurological or musculoskeletal disorders known to interfere with testing PD features
- implanted medical device of any type
- history of seizures
- peripheral neuropathy including temporal mandibular disorders and Bells Palsy, and
- vasovagal syncope.
Data sourced from ClinicalTrials.gov (NCT05871151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.