BridgeMD
New treatment option for Parkinson's Disease
Official title At-home taVNS for Neurorehabilitation in Parkinson's Disease
ClinicalTrials.gov ID: NCT07536022
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 85
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
- A history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
- Inability to complete gait/ motor assessments (without assistance or assistance devices)
See the full eligibility criteria
- 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
- 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
- A history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
- Inability to complete gait/ motor assessments (without assistance or assistance devices)
- Ear trauma, facial pain, anatomical abnormalities or other barriers preventing earpiece fit
- Failure to meet all criteria on a standardized MRI/taVNS safety screening: This includes, but is not limited to, the presence of claustrophobia, implanted electronic devices that are not 3T MRI compatible (e.g...
- Individuals with a diagnosis of cognitive impairment (MoCA \< 24) that would make them unable to understand and follow study instructions or to consent for themselves.
- Pregnancy
- Visual hallucinations or other psychotic symptoms, other than mild visual hallucinations secondary to PD medications, not requiring treatment, or well controlled on stable doses of quetiapine or pimavenserin.
- Individuals with a history of seizure(s)
- Inability to perform at-home taVNS procedures safely and properly (either alone or with the aid of a caregiver)
- Uncorrected visual or hearing impairments that would impact performance on cognitive tests or ability to follow study procedures
- Use of B-Blockers, dopamine blocking agent (other than quetiapine or pimavenserin in stable doses), antiarrhythmic medication, acetylcholine esterase inhibitor (study doctor will consider if on stable doses), midodrine...
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.