CompletedNot Applicable

Combining VNS With PT Interventions for Individuals With PD

United States25 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range

35 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)

Mini-Best Test

Timeframe: 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)

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)

mCTSIB

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)

Trial details

NCT IDNCT05871151

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-25

Results submitted2025-09-05

View on ClinicalTrials.gov More Parkinson Disease trials

Who can participate

Age range

35 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)

Mini-Best Test

Timeframe: 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)

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)

mCTSIB

Timeframe: Baseline, immediately post-treatment (after 12 study visits, around 4-6 weeks), and at follow-up (4 weeks after last treatment)