Combining VNS with PT Interventions for Individuals with PD (VNS-PT-PD)

The University of Alabama at Birmingham

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: taVNS; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05871151

IRB-300010182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

active taVNS + exercise

Experimental group

Description:

Participants who are randomized into the active taVNS + exercise group will receive 15 minutes of active taVNS prior to exercise sessions.

Treatment:

Behavioral: Exercise

Device: taVNS

sham taVNS + exercise

Sham Comparator group

Description:

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

Treatment:

Behavioral: Exercise