At-home taVNS for Neurorehabilitation in Parkinson's Disease
ConditionParkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorMedical University of South Carolina
About this trial
The goal of this clinical trial is to learn if taVNS works to treat symptoms of Parkinson's Disease in adults. It will also learn about the feasibility and preliminary efficacy of taVNS administered at home by the participant.
The main questions it aims to answer are:
1. Is at-home taVNS feasible and effective for treating symptoms of Parkinson's Disease? How often are participants completing the stimulation protocol? What are the side effects of stimulation experienced by participants? How do participants rate the experience of taVNS sessions at home? How do participants' scores on assessments and questionnaires change with taVNS treatments? 2. How does taVNS impact connections between neural networks in the brain of patients with Parkinson's Disease at rest?
Participants will:
* Have a baseline MRI scan to take images of their brain. * Complete a series of assessments and questionnaires to evaluate their Parkinson's Disease motor symptoms, cognitive and neuropsychiatric symptoms, and other non-motor symptoms. * Have an initial taVNS session where their threshold to perceive the stimulation will be measured. This value will be used to stimulate each participant at a specific dose relative to their individual perception of stimulation. * Be trained on how to use the taVNS device and system and have one 1-hour taVNS session where their vitals will be monitored. * Self-administer 1-hour daily taVNS sessions for 8 weeks at-home, complete tolerability questionnaires, and weekly remote check-ins with study staff. * After 4-weeks of at-home taVNS, participants will come in-person to repeat the questionnaires and assessments from the first visit. * Following the 8 weeks of taVNS sessions, participants will repeat the MRI scan, assessments and questionnaires from visit 1. * Participants will complete questionnaires remotely 1 month following their last taVNS sessions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Issues with walking, balance, and gait as determined by a movement disorders neurologist (a score of equal to or greater than 1 on MDS-UPDRS items 2.12 (walking and balance), and 3.10 (gait))
Diagnosis of idiopathic Parkinson's Disease based on UK Brain Bank diagnostic criteria
Hoehn and Yahr Stage 2-4 as determined by a movement disorders neurologist
Stable on dopaminergic medications over the past 30 days prior to enrollment in the study
Disqualifiers
A history of taVNS in the last 6 months
A history of brain surgery, traumatic brain injury or stroke
Diagnosis of a nervous system disorder besides PD, alcohol or substance use disorder, or unstable cardiovascular conditions
History of myocardial infarction or arrhythmia, bradycardia
Trial design
Design model
Single group
Treatments tested in this trial
transcutaneous auricular nerve stimulation
Devicefrequency of 25 Hz, pulse width of 500 µs, duty cycle of 60 seconds ON, 30 seconds OFF, for a duration of 1 hour at an intensity of 200% of individualized perceptual threshold.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: taVNS StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Adherence defined as the percentage of prescribed daily taVNS sessions completed over the 8-week intervention period, measured using automated device usage logs from the Sparrow Link Hub and mobile application.
Time frame
Baseline to end of 8-week at-home taVNS intervention2
Change in Parkinson's Disease Motor Symptoms Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)
Change in motor symptom severity measured using the MDS-UPDRS Part III. Total score range: 0-132, with higher scores indicating worse motor impairment
Time frame
Baseline, Week 4, and Week 8Secondary outcomes
1
Change in Spatiotemporal Gait Parameters
Change in fear of falling measured using the FES-I questionnaire. Total score range: 16-64, with higher scores indicating greater concern about falling.
Time frame
Baseline, Week 4, Week 8, and 1-month follow-upOther outcomes
1
Target Engagement Measured by Resting-State Functional Connectivity MRI
Change in resting-state functional connectivity between locomotor, cognitive, and limbic networks measured using resting-state functional MRI. Connectivity metrics will be derived from seed-based analyses to assess changes in inter-network and intra-network connectivity.
Time frame
Baseline and Week 82
Change in Global Severity and Improvement Assessed by the Clinical Global Impression Scales (CGI-S and CGI-I)
Change in clinician-rated global illness severity (CGI-S) and global improvement (CGI-I). CGI-S score range: 1 (Normal) to 7 (Among the most extremely ill). CGI-I score range: 1 (Very much improved) to 7 (Very much worse).
Time frame
Baseline, Week 4, and Week 83
Change in Freezing of Gait Assessed by the New Freezing of Gait Questionnaire (nFOG-Q)
Change in freezing of gait severity measured by the nFOG-Q. Total score range: 0-28, with higher scores indicating more severe freezing of gait.
Time frame
Baseline, Week 4, Week 8, and 1-month follow-up4
Change in Non-Motor Symptoms Assessed by the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS)
Change in non-motor symptom burden measured using the MDS-NMS. Higher scores indicate greater non-motor symptom severity
Time frame
Baseline, Week 4, Week 8, and 1-month follow-upSponsors and contacts
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Source ClinicalTrials.gov