Parasym Device for Post-COVID Syndrome

Overseen By Jamie Wang

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Casa Colina Hospital and Centers for Healthcare

Disqualifiers: Pacemaker, Metal implants, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Parasym, which uses transcutaneous vagus nerve stimulation (t-VNS). The goal is to determine if this can alleviate "brain fog" and other long COVID symptoms in women who have had COVID-19. Participants will use the device for 60 minutes daily over 10 days to assess improvements in cognitive issues. Women experiencing ongoing brain fog after COVID-19, without other explanations, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for long COVID symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Parasym Device is safe for use in treating Long Covid symptoms?

Research has shown that transcutaneous vagus nerve stimulation (t-VNS) is generally safe. One study found that t-VNS is well-tolerated, with only mild and temporary side effects. These side effects might include skin irritation where the device touches the skin, but they do not last long.

The Parasym Device, which uses this technology, is CE-certified, indicating it meets health and safety standards in Europe. The FDA in the United States has also identified it as having a low risk of causing harm.

Overall, t-VNS has demonstrated good safety in both adults and children, making it a promising tool for managing symptoms without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for post-COVID-19 symptoms, which often focus on medication or physical therapy, the Parasym Device offers a unique approach by utilizing transcutaneous vagus nerve stimulation (t-VNS). This method involves non-invasive electrical stimulation of the vagus nerve through the skin, which can help regulate bodily functions like inflammation and heart rate. Researchers are excited about this technique because it promises a novel, drug-free intervention that could provide relief more quickly and with fewer side effects than current options. Additionally, the use of a wearable fitness tracker ensures that the treatment is both convenient and easy to monitor, potentially leading to more consistent results.

What evidence suggests that the Parasym Device is effective for Long Covid symptoms?

Research has shown that transcutaneous vagus nerve stimulation (t-VNS), which participants in this trial will receive, might reduce depression symptoms, potentially improving mood and cognitive function. One study found that t-VNS improved heart health, suggesting overall health benefits. Additionally, researchers are exploring t-VNS as a therapy that might lower inflammation and stress. These effects could alleviate Long Covid symptoms, such as brain fog, by enhancing brain health. Early data also indicates that t-VNS is safe, making it a promising option for symptom relief. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Zheng, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Are You a Good Fit for This Trial?

Inclusion Criteria

Biologically female at birth and at time of enrollment

You have been experiencing ongoing brain fog or cognitive difficulties for more than 3 months after being infected with COVID-19, and doctors cannot find any other explanation for your symptoms.

Exclusion Criteria

You are currently expecting a baby.

You have long-lasting symptoms from COVID-19, but you do not have any problems with your thinking or memory.

You have a pre-existing neurological condition before getting COVID-19.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 60 minutes of transcutaneous vagus nerve stimulation (t-VNS) every day for 10 consecutive days while wearing a fitness tracker

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive and physiological measures, including fatigue, anxiety, depression, and sleep disturbance

5 weeks

Assessments at baseline, week 3, and week 7

What Are the Treatments Tested in This Trial?

Interventions

• Parasym Device

How Is the Trial Designed?

Group I: Transcutaneous Vagus Nerve Stimulation (t-VNS) Experimental Treatment 1 Intervention

Participants will receive 60 minutes of t-VNS stimulation every day for 10 consecutive days while wearing a fitness tracker.

Parasym Device is already approved in European Union, United States for the following indications:

Approved in European Union as Nurosym for:

• Depression
• Anxiety
• Insomnia
• Pain

Approved in United States as Parasym Device for:

• Non-significant risk designation for various conditions, including depression, anxiety, insomnia, and pain

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials

11

Recruited

350+

Published Research Related to This Trial

A review of over 44,000 adverse event reports related to sacral neuromodulation (SNM) devices found that many reported complications (43.2%) were not true adverse events but rather issues related to device use and the need for better technical support.

The low number of lawsuits (only four identified) over 24 years suggests that SNM devices have a strong safety profile, with complications often stemming from inappropriate patient selection or lack of follow-up rather than device malfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database. Carlton, CE., Souders, CP., Chertack, NA., et al.[2023]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

Citations

1. parasym.co parasym.co/parasym-device-transcutaneous-vagus-nerve-stimulation.html

The Vagus Nerve Stimulation Devices - Parasym Parasympathetic activation leads to decreased inflammation, reduced perceived stress/anxiety, improved sleep etc. Nurosym users can easily regulate the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548598/

Evaluating the efficacy and safety of transcutaneous vagus ... Transcutaneous vagus nerve stimulation (tVNS) emerges as a promising adjunctive therapy, potentially offering a more benign therapeutic avenue ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12231624/

The efficacy of transcutaneous vagus nerve stimulation in ... The meta-analysis results revealed that t-VNS treatment significantly increased LVEF (MD 3.21, 95% CI 1.46 to 4.95, P = 0.0003), improved GLS ( ...

4. parasym.co parasym.co/tVNS-depression.html

Transcutaneous Vagus Nerve Stimulation (tVNS) Reduces ... Data from a growing number of clinical studies demonstrates a strong benefit of tVNS to significantly reduce the severity of depression symptoms across all ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2665913124001122

Safety and preliminary efficacy of transcutaneous auricular ... Our preliminary data demonstrated that tVNS may be a safe pain-relieving treatment for people with knee OA.

6. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... Although taVNS is generally considered safe with only mild and transient adverse effects (AEs), those specifically caused by taVNS have not yet ...

7. parasym.co parasym.co/vagus-nerve-stimulation-vns-tvns.html

Vagus Nerve Modulation - The Future of Bioelectric Medicine At Parasym we have developed an innovative tVNS device and are investigating how stimulation of the vagus nerve can be harnessed to increased patient outcomes ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11543756/

Vagus nerve stimulation (VNS): recent advances and future ... After early pilot trials demonstrated safety, feasibility, and preliminary efficacy [45, 46], the first controlled trials of transcutaneous VNS ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1094715922007644

Transcutaneous Auricular Vagus Nerve Stimulation in ... Compared with invasive vagus nerve stimulation, good safety and tolerability profiles also support the use of tVNS in pediatric patients.