Clinical trial NCT05871151: Combining VNS with PT Interventions for Individuals with PD
Official title: Combining Trans-auricular Vagus Nerve Stimulation with Physical Therapy Interventions for Individuals with Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's Disease
Exercise
Vagus Nerve Stimulation
VNS
taVNS
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with two parallel groups
Primary purpose: TREATMENT

Brief 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 Parkinson\&#39;s 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.

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 \&#34;off\&#34; state

Exclusion Criteria:

* mild cognitive impairment (MoCA \&lt;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.

Primary outcomes:
measure: MDS-UPDRS Part III
timeFrame: 8 weeks
measure: 6MWT
timeFrame: 8 weeks
measure: 10MWT
timeFrame: 8 weeks
measure: Mini-Best Test
timeFrame: 8 weeks
measure: FGA
timeFrame: 8 weeks
measure: mCTSIB
timeFrame: 8 weeks
Secondary outcomes:
measure: MoCA
timeFrame: 8 weeks
measure: DKEFS Color Word Interference Test
timeFrame: 8 weeks
measure: DST
timeFrame: 8 weeks
measure: DSST
timeFrame: 8 weeks
measure: Promise Neuro-QOL
timeFrame: 8 weeks
measure: SF-36
timeFrame: 8 weeks
measure: DKEFS Trails Making Test (Trails)
timeFrame: 8 weeks
measure: DKEFS Verbal Learning Test (VLT)
timeFrame: 8 weeks
measure: Flanker Reaction Time Test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: WHARF
state: Alabama
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Alexandra Evancho, DPT
role: PRINCIPAL_INVESTIGATOR
References: