Vagal Nerve Stimulation for Parkinson's Disease

Overseen By Principal Investigator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colum MacKinnon

Disqualifiers: Stroke, Brain injury, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a device that stimulates a nerve in the neck, known as Vagal Nerve Stimulation, can help people with Parkinson's disease improve muscle activation, walking, and balance. Participants will receive either real or sham (inactive) stimulation to determine any differences in outcomes. Suitable candidates have been diagnosed with Parkinson's, are on stable medication, and can walk unaided for over 50 meters. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance treatment options for Parkinson's disease.

Do I have to stop taking my current medications for the trial?

The trial requires that you have been on stable medication for the past month and expect to continue the same medication for the next 3 months. So, you should not stop taking your current medications.

What prior data suggests that Vagal Nerve Stimulation is safe for Parkinson's Disease?

Research has shown that Vagal Nerve Stimulation (VNS) is generally well-tolerated by people with Parkinson's disease. Studies have found that non-invasive VNS can be safe and effective, particularly for improving walking difficulties.

One study found that VNS was safe for patients and helped with walking issues, which are common in Parkinson's. Another review of the research highlighted VNS's good safety record.

Additionally, a study focusing on the safety and tolerability of VNS found it to be safe when used multiple times. While some studies noted improvements in walking, not all movement symptoms showed the same level of improvement.

Overall, the evidence suggests that VNS is a safe treatment option with a good safety record for those with Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vagal Nerve Stimulation (VNS) for Parkinson's disease because it offers a unique approach compared to standard treatments like medication, deep brain stimulation, and physical therapy. Unlike these traditional options, VNS works by stimulating the vagus nerve, which may help regulate brain function and reduce symptoms without the invasive procedures associated with some other treatments. Additionally, VNS has the potential to be a non-pharmaceutical option, which is appealing for patients looking to minimize drug side effects. This novel mechanism of action and its potential for non-invasiveness make VNS a promising candidate in the search for effective Parkinson's treatment options.

What evidence suggests that Vagal Nerve Stimulation is effective for Parkinson's Disease?

Research has shown that Vagal Nerve Stimulation (VNS) might help people with Parkinson's disease (PD). In this trial, participants will join different arms, including Real nVNS and Sham nVNS, to evaluate its effects. Studies have found that VNS can improve walking in people with PD, although one study noted it didn’t significantly help other PD symptoms. Earlier research suggests VNS may reduce freezing of gait (FOG), a common problem in PD. VNS might also help with brain inflammation, which can relate to PD. However, the evidence is mixed, and some studies report only small to moderate improvements in movement. Overall, VNS seems promising, but more research is needed to fully understand its effects. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's disease who are interested in exploring how vagal nerve stimulation might affect their leg muscle activity and posture.

Inclusion Criteria

My current medications have been stable for the last month and will remain so.

I can walk more than 50 meters without help.

I have been diagnosed with Parkinson's disease.

Exclusion Criteria

Insufficient comprehension of the English language

History of substance abuse in past 2 years

I have had fainting spells or seizures in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline (no VNS)

Participants undergo baseline measurements without vagus nerve stimulation

1-4 weeks

Multiple sessions

Real nVNS

Participants receive real non-invasive vagus nerve stimulation to assess its effects on muscle activity and postural control

Within-session: 0-60 minutes; Between sessions: 1-4 weeks

Multiple sessions

Sham nVNS

Participants receive sham vagus nerve stimulation as a control to compare against real nVNS effects

Within-session: 0-60 minutes; Between sessions: 1-4 weeks

Multiple sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vagal Nerve Stimulation

Trial Overview The study investigates the effects of stimulating a nerve in the neck on leg muscle activation, walking, and balance in people with Parkinson's. It compares results from those receiving the stimulation to those without any intervention.

How Is the Trial Designed?

Group I: Real nVNS Experimental Treatment 1 Intervention

Group II: Baseline (no VNS) Experimental Treatment 1 Intervention

Within-subject and cross-sectional design that consists of 30 participants with PD (15 with PIGD and 15 without PIGD) and 15 matched controls.

Group III: Sham nVNS Placebo Group 1 Intervention

Sham VNS will be applied using setting that do not active the vagus nerve.

Who Is Running the Clinical Trial?

Colum MacKinnon

Lead Sponsor

Parkinson's Foundation

Collaborator

Trials

13

Recruited

1,030,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40057881/

Noninvasive Vagus Nerve Stimulation in Parkinson's Disease Ten studies reported that VNS significantly improved gait characteristics. Category fluency significantly declined in one study. Additionally, nonsignificant ...

2. nature.com nature.com/articles/s41531-024-00803-1

Vagus nerve stimulation in Parkinson's disease: a scoping ... This scoping review maps existing literature on VNS for PD, highlighting stimulation methods, operational parameters, safety profiles, neurophysiological ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586824005551

Effectiveness of non-invasive vagal nerve stimulation in ... Our finding suggests a potential benefit of nVNS in reducing FOG in PD, but did not demonstrate a significant improvement in other motor symptoms.

4. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2024.1498176/full

Transcutaneous vagus nerve stimulation for Parkinson's ... It has small to moderate therapeutic effects on motor functions and may negatively impact on a few other outcomes. Quality level of the evidence is low and ...

5. academic.oup.com academic.oup.com/ijnp/article/28/Supplement_2/ii74/8237068

497. THE EFFECTIVENESS OF VAGUS NERVE ... Overall, the evidence shows the positive effects of VNS in modulating neuroinflammation suggesting its role in restoring LC function. This ...

6. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-023-03081-1

Safety and tolerability of adjunct non-invasive vagus nerve ... The primary outcome measure is the safety and tolerability of multi-dose nVNS in PD. Secondary outcomes include improvements in gait, cognition ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511173/

Feasibility, safety and efficacy of multi-dose vagus nerve ... Overall, this study successfully establishes the feasibility of multi-dose tcVNS as a novel therapeutic approach in PD. We furthermore ...