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NCT05871151 | COMPLETED | Parkinson Disease

Combining VNS with PT Interventions for Individuals with PD
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Alexandra Evancho

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\'s Disease.

Condition or disease

Parkinson Disease

Intervention/treatment

taVNS

Exercise

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : SINGLE
Masking Description : Participants will receive either active or sham taVNS + exercise, but they will not be aware of whether they are receiving the active treatment or the sham treatment.
Primary Purpose : TREATMENT
Official Title : Combining Trans-auricular Vagus Nerve Stimulation with Physical Therapy Interventions for Individuals with Parkinson's Disease
Actual Study Start Date : 2023-09-01
Estimated Primary Completion Date : 2024-07-25
Estimated Study Completion Date : 2024-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 \"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.
Combining VNS with PT Interventions for Individuals with PD

Location Details

NCT05871151

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Albama

WHARF

Birmingham, Albama, United States, 35209

Not yet recruiting

United States, Albama

UAB

Birmingham, Albama, United States, 35233