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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| taVNS Stimulation | Experimental | one in-person taVNS session followed by 8 weeks of at-home taVNS sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular nerve stimulation | Device | frequency 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to end of 8-week at-home taVNS intervention |
| 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 | Baseline, Week 4, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 4, Week 8, and 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 8 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Lench, PhD | Contact | +843-792-9115 | lenchd@musc.edu | |
| Emily Laramie, HBSc | Contact | +843-792-3873 | laramie@musc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
Information about participants (including their identifiable private information and/or any identifiable biospecimens) may have all of their identifiers removed and used for future research studies or distributed to other researchers for future research without additional informed consent from participants or their legally authorized representative. This is documented in the informed consent form.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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). | Baseline, Week 4, and Week 8 |
| 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. | Baseline, Week 4, Week 8, and 1-month follow-up |
| 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 | Baseline, Week 4, Week 8, and 1-month follow-up |
| Change in Cognitive Function Assessed by Neuropsychological Testing | Change in cognitive performance assessed using standardized neuropsychological tests including the Delis-Kaplan Executive Function System (verbal fluency and switching), Stroop Color-Word Interference Test, Digit Span, and FAS Verbal Fluency Test. Higher test scores indicate better cognitive performance. | Baseline, Week 4, and Week 8 |
| Change in Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A) | Change in anxiety severity measured by the HAM-A. Score range: 0-56, with higher scores indicating greater anxiety severity. | Baseline, Week 4, and Week 8 |
| Change in Depressive Symptoms Assessed by the Hamilton Depression Rating Scale (HAM-D) | Change in depressive symptom severity measured by the HAM-D. Higher scores indicate greater depressive symptom severity. | Baseline, Week 4, and Week 8 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |