Parkinson DiseaseVNS-PT-PDNCT05871151
Combining VNS With PT Interventions for Individuals With PD
A study testing taVNS and Exercise in people with Parkinson Disease, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- taVNS and Exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- implanted medical device of any type
- history of seizures
- peripheral neuropathy including temporal mandibular disorders and Bells Palsy, and
- vasovagal syncope.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
WHARF
Birmingham, Alabama, 35209
UAB
Birmingham, Alabama, 35233
About this study
Official title: Combining Trans-auricular Vagus Nerve Stimulation With Physical Therapy Interventions for Individuals With Parkinson's Disease
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.
Read the detailed description
During this clinical trial, participants will be randomized into two groups, with half of the participants assigned to GROUP 1: active taVNS + exercise, and half of the participants assigned to GROUP 2: sham taVNS + exercise. The active taVNS + exercise group will receive 15 minutes of active taVNS prior to treatment. Participants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to treatment. All participants will be guided through exercises by a licensed physical therapist, which will include: 1) intensive exercises that focus on increasing the size and amplitude of movements; 2) task-specific practice, which involves practicing functional tasks, such as dressing, bathing, and cooking, in order to transfer the gains made in therapy to real-life situations. The exercise intervention proposed involves the supervision of a licensed PT at all times during the treatment session. Exercise will be provided in a clinical setting, 45 minutes per session, up to 3 sessions/week, for 4-6 weeks total.
- Conditions
- Parkinson Disease
- Being tested
- taVNS, Exercise
- Keywords
- Parkinson's Disease, Exercise, Vagus Nerve Stimulation, VNS, taVNS
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Trans-auricular Vagus Nerve Stimulation is a non-invasive method of stimulating the auricular branch of the vagus nerve through the inner ear. Trans-auricular Vagus Nerve Stimulation will be provided using a commercially available device. The investigators will use custom earbuds that will make the experience significantly more comfortable than traditional transauricular Vagus Nerve Stimulation.
ExerciseBehavioural
All participants will be guided through exercises led by a trained exercise specialist, and will include: 1) intensive exercises that focus on increasing the size and amplitude of movements; 2) task-specific practice, which involves practicing functional tasks, such as dressing, bathing, and cooking, in order to transfer the gains made in therapy to real-life situations. The exercise intervention proposed involves the supervision of a licensed PT at all times during the treatment session. Exercise will be provided in a clinical setting, 45 minutes per session, up to 3 sessions/week, for 4-6 weeks total.
| Study group | Role | What they receive |
|---|---|---|
| active taVNS + exercise | Experimental | Participants who are randomized into the active taVNS + exercise group will receive 15 minutes of active taVNS prior to exercise sessions. Receives: Device: taVNS; Behavioral: Exercise |
| sham taVNS + exercise | Sham comparator | Participants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to exercise sessions. Receives: Device: taVNS; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
In our study, we will utilize the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. This scale, widely used in the clinical and research settings, helps us evaluate the motor symptoms of Parkinson's Disease.
The MDS-UPDRS Part III scale ranges from 0 to 132, with 0 representing no motor symptoms and 132 representing severe motor symptoms. Therefore, a higher score on the MDS-UPDRS Part III scale indicates a worse outcome, reflecting more severe motor symptoms associated with Parkinson's disease.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Six Minute Walk Test (6MWT)
6-Minute Walk Test (6MWT): We utilize the 6-Minute Walk Test in our study to evaluate the functional exercise capacity of our participants. The 6MWT involves participants walking as far as they can in a span of six minutes on a flat, hard surface. The total distance covered in six minutes is recorded as the score. In this test, a greater distance indicates better physical endurance and mobility. Therefore, in our study, a higher score (greater distance walked) on the 6MWT represents a better outcome, signifying superior functional exercise capacity.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Ten Meter Walk Test (10MWT)
The 10MWT is a timed walking test commonly used in clinical and research settings to assess an individual's gait speed and functional mobility. It measures the time it takes for a person to walk a distance of 10 meters (approximately 33 feet). The scale title, in this case, is the time in seconds required to complete the 10-meter walk. There are no specific minimum and maximum values for this measure since it depends on the individual's walking ability. However, lower scores (i.e., shorter times) generally indicate better outcomes, as they reflect faster gait speed and improved mobility. Conversely, higher scores (longer times) would suggest slower walking speed and potentially poorer functional mobility.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Mini-Best Test
The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment tool used to evaluate a person's balance and stability. It consists of 14 items that assess different aspects of balance, including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait, and stability during functional tasks. The scale title for the Mini-BESTest is the total score, which ranges from 0 to 28. Higher scores on the Mini-BESTest indicate better balance performance and greater overall stability. A score of 28 represents the best possible outcome, indicating excellent balance abilities across all assessed domains. Conversely, lower scores indicate poorer balance control and increased risk of falls.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Functional Gait Assessment (FGA)
The Functional Gait Assessment (FGA) is a clinical measure used to assess an individual's walking ability and functional mobility. It evaluates various aspects of gait, including balance, coordination, range of motion, and adaptability. The FGA consists of 10 different tasks or conditions that challenge the person's walking abilities in different ways, such as walking while turning, walking over obstacles, or walking with eyes closed. The scale title for the FGA is the total score, which ranges from 0 to 30. Higher scores on the FGA indicate better functional gait performance and greater walking independence. A score of 30 represents the best possible outcome, reflecting excellent gait function across all assessed conditions. Conversely, lower scores suggest impaired gait function and reduced functional mobility.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
mCTSIB
The modified Clinical Test of Sensory Interaction on Balance (mCTSIB) is a diagnostic tool used to evaluate an individual's sensory integration and balance control. It assesses the person's ability to maintain balance under various sensory conditions. The mCTSIB involves four different standing positions, each with different sensory inputs: (1) feet together on a firm surface with eyes open, (2) feet together on a firm surface with eyes closed, (3) feet together on a foam surface with eyes open, and (4) feet together on a foam surface with eyes closed. The results presented in this section reflect the participant's composite mCTSIB score as measured by the BTrack Balance System. Composite scores range from 0 to 400. Higher scores indicate better balance control and greater sensory integration.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Secondary outcomes (10)
MoCA
The Montreal Cognitive Assessment (MoCA) is a widely accepted tool in both clinical and research settings, allowing us to evaluate cognitive abilities, specifically focusing on attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
The MoCA scale ranges from 0 to 30, with a score of 30 indicating the highest level of cognitive function. Lower scores on the MoCA suggest a higher level of cognitive impairment. Therefore, in the context of our study, a higher score on the MoCA represents a better outcome, signifying superior cognitive performance.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference Test - Condition One
Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 1 is basic naming of color patches. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference Test - Condition Two
Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 2 is basic reading of color-words printed in black ink. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference - Condition Three
Delis-Kaplan Executive Function System (D-KEFS) Color Word Interference Test is used to assess cognitive flexibility and inhibitory control. Condition 3 is the traditional Stroop task, for which the examinee must inhibit reading the words in order to name the dissonant ink colors in which those words are printed. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Verbal Fluency Test
For the Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (letter fluency), the examinee is asked to generate words that begin with a particular letter as quickly as possible in 60 seconds. The test measures the examinee's ability to generate words fluently in an effortful, phonemic format. All D-KEFS raw scores are converted to scaled scores, with a mean of 10 and a standard deviation of 3, corrected for each of the following 16 age-groups:8, 9, 10, 11, 12, 13, 14, 15, 16-19, 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80-89. Higher scores indicate better performance.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Digit Span Test
The Digit Span test is a working memory test in which participants hear a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. There are 14 "spans" of numbers, and each span is scored '1' (pass) or '0' (fail). Scores range from 0-14, with higher scores indicating better working memory.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Digit Symbol Substitution Test
The DSST is a test of psychomotor and cognitive functions, including speed of processing, attention, memory, and manual dexterity. The test requires participants to substitute symbols for numbers based on a key, filling in as many blanks as possible within 90 seconds. Scores range from 0-90, and higher scores indicate better function.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Flanker
The Flanker Inhibitory Control and Attention Test is an NIH Toolbox cognitive assessment of inhibitory control and attention. Participants respond to a central stimulus while ignoring flanking stimuli. Raw performance is based on accuracy across congruent and incongruent trials and, for participants with accuracy greater than 80 percent, reaction time is incorporated into the score. Accuracy and reaction time are each converted to a 0-5 subscore using NIH Toolbox scoring algorithms, and these subscores are summed to create a total raw score.
This raw score is then converted to an age-adjusted scale score using nationally representative normative data. In this scoring system, a value of 100 represents the population mean for individuals of the same age, with a standard deviation of 15. Higher age-adjusted scale scores indicate better inhibitory control and attention, whereas lower scores represent poorer performance. Scale scores below approximately 85 (one standard deviation below th
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Promise Neuro-QOL (Ability)
The Patient Reported Outcomes Measurement Information System (PROMIS) Quality of Life in Neurological Disorders (Neuro-QoL) system assesses health-related quality of life in individuals with neurological conditions. The Neuro-QoL Ability to Participate in Social Roles and Activities scale evaluates a participant's self-reported ability to perform and engage in day-to-day activities. Scores are reported as T-scores, where 50 represents the population mean and 10 represents one standard deviation.
Higher T-scores on this scale indicate better perceived ability and therefore reflect a more favorable outcome. Lower T-scores represent worse perceived ability. Clinically meaningful thresholds may include T-scores below approximately 40 (one standard deviation below the mean), which may indicate notably reduced ability to participate in daily activities.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
SF-36
The SF-36 is a self-reported questionnaire measuring health-related quality of life. It assesses dimensions like physical functioning, role limitations, pain, general health, vitality, social functioning, and mental health. It provides scores for each dimension and summary scores (PCS and MCS) for overall physical and mental health. Scale titles reflect specific dimensions. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. SF-36 offers a comprehensive assessment of perceived health status and well-being.
Measured: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Oct 2023
- Primary completion25 May 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial with two parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Evancho, University of Alabama at Birmingham
- Investigators
- Alexandra Evancho, DPT, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871151
- Sponsor's protocol ID
- IRB-300010182
- Acronym
- VNS-PT-PD
- Status last verified
- Nov 2025
- First submitted
- 12 May 2023
- Last updated
- 17 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Evancho A, Dawson J, Walker HC, Ballmann CG, Tyler WJ. Auricular Vagus Nerve Stimulation Combined with Physical Therapy for Individuals with Parkinson's Disease: A Pilot Randomized Sham-Controlled Trial. Neurol Int. 2026 Jun 17;18(6):118. doi: 10.3390/neurolint18060118.
PubMed 42347126
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Trans-auricular Vagus Nerve Stimulation With Physical Therapy Interventions for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05871151
- Acronym / sponsor ID
- VNS-PT-PD / IRB-300010182
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Exercise, Vagus Nerve Stimulation, VNS, taVNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Posted 17 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During this clinical trial, participants will be randomized into two groups, with half of the participants assigned to GROUP 1: active taVNS + exercise, and half of the participants assigned to GROUP 2: sham taVNS + exercise. The active taVNS + exercise group will receive 15 minutes of active taVNS prior to treatment. Participants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to treatment. All participants will be guided through exercises by a licensed physical therapist, which will include: 1) intensive exercises that focus on increasing the size and amplitude of movements; 2) task-specific practice, which involves practicing functional tasks, such as dressing, bathing, and cooking, in order to transfer the gains made in therapy to real-life situations. The exercise intervention proposed involves the supervision of a licensed PT at all times during the treatment session. Exercise will be provided in a clinical setting, 45 minutes per session, up to 3 sessions/week, for 4-6 weeks total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| active taVNS + exercise | Experimental | Device: taVNS, Behavioral: ExerciseParticipants who are randomized into the active taVNS + exercise group will receive 15 minutes of active taVNS prior to exercise sessions. |
| sham taVNS + exercise | Sham comparator | Device: taVNS, Behavioral: ExerciseParticipants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to exercise sessions. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNSTrans-auricular Vagus Nerve Stimulation is a non-invasive method of stimulating the auricular branch of the vagus nerve through the inner ear. Trans-auricular Vagus Nerve Stimulation will be provided using a commercially available device. The investigators will use custom earbuds that will make the experience significantly more comfortable than traditional transauricular Vagus Nerve Stimulation. | Device | active taVNS + exercise, sham taVNS + exercise |
| ExerciseAll participants will be guided through exercises led by a trained exercise specialist, and will include: 1) intensive exercises that focus on increasing the size and amplitude of movements; 2) task-specific practice, which involves practicing functional tasks, such as dressing, bathing, and cooking, in order to transfer the gains made in therapy to real-life situations. The exercise intervention proposed involves the supervision of a licensed PT at all times during the treatment session. Exercise will be provided in a clinical setting, 45 minutes per session, up to 3 sessions/week, for 4-6 weeks total. | Behavioural | active taVNS + exercise, sham taVNS + exercise |
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
In our study, we will utilize the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. This scale, widely used in the clinical and research settings, helps us evaluate the motor symptoms of Parkinson's Disease. The MDS-UPDRS Part III scale ranges from 0 to 132, with 0 representing no motor symptoms and 132 representing severe motor symptoms. Therefore, a higher score on the MDS-UPDRS Part III scale indicates a worse outcome, reflecting more severe motor symptoms associated with Parkinson's disease.
Six Minute Walk Test (6MWT)
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
6-Minute Walk Test (6MWT): We utilize the 6-Minute Walk Test in our study to evaluate the functional exercise capacity of our participants. The 6MWT involves participants walking as far as they can in a span of six minutes on a flat, hard surface. The total distance covered in six minutes is recorded as the score. In this test, a greater distance indicates better physical endurance and mobility. Therefore, in our study, a higher score (greater distance walked) on the 6MWT represents a better outcome, signifying superior functional exercise capacity.
Ten Meter Walk Test (10MWT)
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
The 10MWT is a timed walking test commonly used in clinical and research settings to assess an individual's gait speed and functional mobility. It measures the time it takes for a person to walk a distance of 10 meters (approximately 33 feet). The scale title, in this case, is the time in seconds required to complete the 10-meter walk. There are no specific minimum and maximum values for this measure since it depends on the individual's walking ability. However, lower scores (i.e., shorter times) generally indicate better outcomes, as they reflect faster gait speed and improved mobility. Conversely, higher scores (longer times) would suggest slower walking speed and potentially poorer functional mobility.
Mini-Best Test
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment tool used to evaluate a person's balance and stability. It consists of 14 items that assess different aspects of balance, including anticipatory postural adjustments, reactive postural control, sensory orientation, dynamic gait, and stability during functional tasks. The scale title for the Mini-BESTest is the total score, which ranges from 0 to 28. Higher scores on the Mini-BESTest indicate better balance performance and greater overall stability. A score of 28 represents the best possible outcome, indicating excellent balance abilities across all assessed domains. Conversely, lower scores indicate poorer balance control and increased risk of falls.
Functional Gait Assessment (FGA)
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
The Functional Gait Assessment (FGA) is a clinical measure used to assess an individual's walking ability and functional mobility. It evaluates various aspects of gait, including balance, coordination, range of motion, and adaptability. The FGA consists of 10 different tasks or conditions that challenge the person's walking abilities in different ways, such as walking while turning, walking over obstacles, or walking with eyes closed. The scale title for the FGA is the total score, which ranges from 0 to 30. Higher scores on the FGA indicate better functional gait performance and greater walking independence. A score of 30 represents the best possible outcome, reflecting excellent gait function across all assessed conditions. Conversely, lower scores suggest impaired gait function and reduced functional mobility.
mCTSIB
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
The modified Clinical Test of Sensory Interaction on Balance (mCTSIB) is a diagnostic tool used to evaluate an individual's sensory integration and balance control. It assesses the person's ability to maintain balance under various sensory conditions. The mCTSIB involves four different standing positions, each with different sensory inputs: (1) feet together on a firm surface with eyes open, (2) feet together on a firm surface with eyes closed, (3) feet together on a foam surface with eyes open, and (4) feet together on a foam surface with eyes closed. The results presented in this section reflect the participant's composite mCTSIB score as measured by the BTrack Balance System. Composite scores range from 0 to 400. Higher scores indicate better balance control and greater sensory integration.
10 secondary outcomes
MoCA
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference Test - Condition One
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference Test - Condition Two
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Color Word Interference - Condition Three
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
DKEFS Verbal Fluency Test
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Digit Span Test
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Digit Symbol Substitution Test
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Flanker
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Promise Neuro-QOL (Ability)
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
SF-36
Time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42347126Evancho A, Dawson J, Walker HC, Ballmann CG, Tyler WJ. Auricular Vagus Nerve Stimulation Combined with Physical Therapy for Individuals with Parkinson's Disease: A Pilot Randomized Sham-Controlled Trial. Neurol Int. 2026 Jun 17;18(6):118. doi: 10.3390/neurolint18060118.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Evancho, DPT principal investigator
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS and Exercise in people with Parkinson Disease, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (time frame: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05871151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.