Multimodal Investigation of Post COVID-19 in Females

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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a device that sends gentle electrical signals to a nerve in the neck to help women with Long COVID who have trouble thinking clearly. The goal is to improve brain function and reduce symptoms like 'brain fog.'

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.

Is the Parasym Device generally safe for humans?

The safety evaluation of non-active implantable medical devices (like the Parasym Device) is less comprehensive than that for medicines, with no global program for collecting and analyzing adverse events. However, efforts are being made to improve safety monitoring through initiatives like the unique device identifier (UDI) system, which could enhance long-term safety assessments. ^{1 2 3 4 5}

How is the Parasym Device treatment different from other treatments for this condition?

The Parasym Device, also known as Nurosym, is unique because it is a non-invasive device that uses electrical stimulation to target the nervous system, potentially offering a novel approach compared to traditional drug therapies. Unlike implantable devices, it does not require surgery, making it a less invasive option for patients. ^{6 7 8 9 10}

Research Team

Amy Zheng, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria

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

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

Treatment Details

Interventions

• Parasym Device

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Primary safety results from the LEADLESS Observational Study. [2019]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Development of a new implantable bio-telestimulator. [2003]

7. Canada pubmed.ncbi.nlm.nih.gov

A standardized surgical technique for removal of the Interstim tined lead. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with a helical bipolar stimulating lead. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The implantable neurocybernetic prosthesis system. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

A custom designed chip to control an implantable stimulator and telemetry system for control of paralyzed muscles. [2019]