Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study plans to learn more about how stimulating the vagus nerve through gentle electrical stimulation applied to the ear can affect decision-making, problem-solving, and other thinking abilities. This process, called transcutaneous auricular vagus nerve stimulation (taVNS), could help improve brain function in both healthy individuals and people with Parkinson's disease (PD).
This is a single-site pilot study to assess the safety, feasibility, and potential therapeutic effect of paired-taVNS cognitive training in healthy individuals and people with PD. In the longitudinal study, healthy and PD participants will be prospectively assigned to receive either the sham or active intervention based on order of enrollment in the study. In the acute study, healthy participants will receive both the sham and active intervention, where the order will be prospectively randomized based on order of enrollment in the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active stimulation (healthy controls) | Experimental | Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation |
|
| sham stimulation (healthy controls) | Sham Comparator | Participants in this arm will receive sham stimulation that does not target the vagus nerve |
|
| active stimulation (Patients with Parkinson's Disease) | Experimental | Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation |
|
| sham stimulation (patients with Parkinson's Disease) | Sham Comparator | Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Device | Electrical stimulation targeting the auricular branch of the vagus nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lack of adverse events (AEs) and serious adverse events (SAEs) | a lack of AEs and SAEs during the paired-taVNS intervention | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Task Performance | Accuracy on Stroop Color-Word Task | From enrollment to the end of treatment at 6 months |
| Executive Function network modulation | Measured via MEG to assess changes in functional connectivity and network dynamics in cortical regions implicated in EF. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological biomarkers of taVNS | We will look at the relative (%) change in pupil diameter in response to taVNS | From enrollment to the end of treatment at 6 months |
Inclusion Criteria:
Exclusion Criteria:
(6) Other significant diseases or disorders that might impair study participation.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise R Carter | Contact | 3094335932 | elise.carter@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Cristin Welle, PhD | Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Translational Research Center at CU Anschutz | Recruiting | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| sham stimulation | Device | Sham stimulation of the outer ear that does not target the vagus nerve |
|
| From enrollment to the end of treatment at 6 months |
| Subjective experience | Patient reported response to perception of stimulation using a 10-point Likert scale where 0 is no sensation and 10 is painful | From enrollment to the end of treatment at 6 months |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided