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 range35 Years – 80 Years

SexALL

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.

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 range35 Years – 80 Years

SexALL

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)