Combining VNS With PT Interventions for Individuals With PD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05871151
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • taVNS — DEVICE
    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.
  • Exercise — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
Nov 2025
Primary completion
May 25, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active taVNS + exercise
    Participants who are randomized into the active taVNS + exercise group will receive 15 minutes of active taVNS prior to exercise sessions.
  • Sham Comparator: sham taVNS + exercise
    Participants who are randomized into the sham taVNS + exercise group will receive 0 mA of current for 15 minutes prior to exercise sessions.

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) ]

Locations (2)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35233-
WHARFBirminghamAlabama35209-

Find similar trials in Birmingham, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UAB· Birmingham, ALWHARF· Birmingham, AL

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