At-home taVNS for Neurorehabilitation in Parkinson's Disease
Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "How do participants' scores on assessments and questionnaires change with taVNS treatments? 2."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether taVNS, a treatment that stimulates a nerve through the ear, can help adults with Parkinson’s disease. It also checks whether people can use it safely at home and how it affects brain connections. Participants use the device for 1 hour each day for 8 weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have walking and balance problems confirmed by a doctor who treats movement disorders.
- Have idiopathic Parkinson’s disease, meaning the cause is unknown, diagnosed using the study’s required standards.
- Have Parkinson’s disease at stage 2 to 4 on the Hoehn and Yahr scale, as checked by a movement disorders doctor.
- Have been on stable doses of medicines that affect dopamine for at least 30 days before joining.
Who can't join
- Used taVNS in the past 6 months, or cannot use it safely at home, even with a caregiver’s help.
- Have had brain surgery, a brain injury, a stroke, or seizures; have another nervous system disorder; or have an alcohol or drug use disorder.
- Have an unstable heart or blood vessel condition, a past heart attack, an abnormal heart rhythm, or a slow heartbeat.
- Have major walking problems not caused by Parkinson’s disease, or cannot complete walking and movement tests without help or assistive devices.
- Have ear injuries, face pain, or other problems that prevent the earpiece from fitting; or fail MRI/taVNS safety checks. Examples include fear of tight spaces, unsafe implanted devices, metal fragments, or hair clips or piercings that cannot be removed.
- Are pregnant; have thinking or memory problems that prevent understanding instructions or giving consent, with a MoCA thinking-test score below 24; or have uncorrected sight or hearing problems that affect testing or following instructions.
- Have hallucinations, such as seeing things that are not there, or other symptoms of losing touch with reality. Exceptions include mild visual hallucinations from Parkinson’s medicines that need no treatment, or symptoms well controlled with stable doses of quetiapine or pimavenserin.
- Take beta-blockers, medicines that block dopamine, medicines for abnormal heart rhythms, acetylcholinesterase inhibitors, midodrine, fludrocortisone, droxidopa, or anticholinergic drugs. Stable doses of quetiapine or pimavenserin are allowed. The study doctor may allow acetylcholinesterase inhibitors at stable doses.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 Exclusion Criteria: * 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., pacemakers), metallic objects or fragments (e.g., bullets), and non-removable hair clips or piercings. * 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, fludrocortisone, droxidopa, or anticholinergic drugs
Study sites (1)
SC
- Medical University of South Carolina · Charleston, SC 29425Daniel Lench, PhD · Principal investigatorMore trials in Charleston