16 Participants NeededMy employer runs this trial

At-home taVNS for Parkinson's Disease

EL
DL
Overseen ByDaniel Lench, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
Must be taking: Dopaminergic medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if transcutaneous auricular nerve stimulation (taVNS), a non-invasive method that stimulates nerves in the ear, can alleviate symptoms of Parkinson's Disease. Participants will use the device at home daily for eight weeks to assess its practicality and effectiveness in improving symptoms like walking and balance. The trial also examines how taVNS affects brain connections in individuals with Parkinson's Disease. It suits those diagnosed with Parkinson's Disease who experience walking or balance issues and have been stable on their medication for at least 30 days. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to advancing Parkinson's Disease research.

Will I have to stop taking my current medications?

The trial requires that you stay on stable doses of your current dopaminergic medications for at least 30 days before joining. However, you cannot participate if you are using certain medications like B-Blockers, dopamine blocking agents (except quetiapine or pimavenserin in stable doses), and some others. It's best to discuss your specific medications with the study doctor.

What prior data suggests that this at-home taVNS protocol is safe for treating Parkinson's Disease?

Research has shown that transcutaneous auricular nerve stimulation (taVNS) is generally safe. Studies have found that people tolerate taVNS well, with no reports of serious side effects. Although some minor side effects have been noted, they are not considered serious. For example, one study found that taVNS was safely used in people with Parkinson's Disease, suggesting it might help manage symptoms without major risks. Overall, while minor side effects can occur, research indicates that taVNS is safe.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Parkinson's Disease, which often include medications like levodopa that address symptoms by boosting dopamine levels in the brain, transcutaneous auricular vagus nerve stimulation (taVNS) offers a unique approach. This treatment is applied through the skin to stimulate the vagus nerve via the ear, which could potentially modify brain activity and improve motor function. Researchers are excited about taVNS because it can be administered at home, making it more convenient for patients and potentially offering a non-invasive alternative to existing therapies.

What evidence suggests that taVNS is effective for treating Parkinson's Disease?

Research has shown that transcutaneous auricular nerve stimulation (taVNS) may benefit people with Parkinson's Disease. In this trial, participants will undergo one in-person taVNS session followed by 8 weeks of at-home sessions. Studies suggest that taVNS can ease movement problems, as indicated by lower scores on Parkinson's assessments, and improve other issues like quality of life. It appears to enhance brain function, supporting both movement and mental functions, which benefits Parkinson's patients. Some research also found that it can help people walk faster and take longer steps. However, results can vary, and some studies show only modest improvements, particularly with movement problems. Overall, early findings suggest taVNS could be a promising way to manage Parkinson's symptoms.26789

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with Parkinson's Disease who have trouble walking or balancing, are stable on their medications, and can safely use an at-home nerve stimulation device. People with certain heart conditions, other brain disorders, recent ear trauma, MRI-incompatible implants, or severe cognitive issues cannot join.

Inclusion Criteria

My dopaminergic medication dose has not changed in the past 30 days.
My Parkinson's disease is at stage 2 to 4.
I have problems with walking, balance, or gait as confirmed by a specialist.
See 1 more

Exclusion Criteria

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
A history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
Ear trauma, facial pain, anatomical abnormalities or other barriers preventing earpiece fit
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a baseline MRI scan and complete assessments and questionnaires to evaluate Parkinson's Disease symptoms.

1 day
1 visit (in-person)

Initial taVNS Session

Participants have an initial taVNS session to measure their threshold for stimulation and are trained on device usage.

1 day
1 visit (in-person)

At-home taVNS Treatment

Participants self-administer 1-hour daily taVNS sessions for 8 weeks at home, with weekly remote check-ins.

8 weeks
Weekly remote check-ins

Midpoint Assessment

Participants repeat questionnaires and assessments after 4 weeks of at-home taVNS.

1 day
1 visit (in-person)

Post-treatment Assessment

Following 8 weeks of taVNS sessions, participants repeat the MRI scan, assessments, and questionnaires.

1 day
1 visit (in-person)

Follow-up

Participants complete questionnaires remotely 1 month following their last taVNS sessions.

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • transcutaneous auricular nerve stimulation

Trial Overview

The study tests if daily at-home transcutaneous auricular vagus nerve stimulation (taVNS) helps improve symptoms of Parkinson's Disease. Participants self-administer the treatment for 8 weeks and complete assessments before, during, and after the intervention.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: taVNS StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

Transcutaneous auricular vagus nerve stimulation in ...

taVNS could regulate brain activity, motor and mental functions, and autonomic nervous system activity in patients with stroke and Parkinson's ...

Home-based transcutaneous auricular vagus nerve ... - PMC

TaVNS significantly improved motor symptoms, reflected as reduced MDS-UPDRS Ⅲ scores, and alleviated non-motor symptoms including quality of ...

Transcutaneous auricular vagus nerve stimulation ...

Interestingly, taVNS treatment improved PD motor symptoms by increasing Ne in the right M1 and enhancing intracortical facilitation (ICF, ISI 10 ...

Effect of Transcutaneous Auricular Vagus Nerve ...

In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) >2 and L-dopa ...

Effects of transcutaneous auricular vagus nerve stimulation ...

taVNS may provide modest benefits for PD, with improvements observed in motor function and stride length, but no clear effect on gait speed.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41549029/

Home-based transcutaneous auricular vagus nerve ...

No serious adverse events occurred. These findings suggest that taVNS with specific parameters effectively alleviates motor and non-motor ...

Effects of Transcutaneous Vagus Nerve Stimulation in ...

This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37554394/

Multi-session transcutaneous auricular vagus nerve ...

Conclusions: taVNS was safe, and well-tolerated in PD participants. Future studies of taVNS for PD should explore at-home stimulation devices ...

Analyzing the Effectiveness of Transcutaneous Auricular ...

Our results suggest that taVNS is only partially effective in improving gait dysfunction related to Parkinson's Disease, with slight increases in walk speed ...