Phase II Trial of Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness

(Nu-V3P2RCT Trial)

Recruiting at 1 trial location

Overseen By Mike Zess

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nu-Life Solutions

Disqualifiers: Hearing aid, Pacemaker, Bradycardia, Transplant, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called Nu-V3 that you wear on your ear. It sends gentle electrical signals to help with chronic pain, anxiety, depression, and trouble sleeping. The study focuses on people who have these ongoing symptoms and aims to see if the device can improve their quality of life.

Will I have to stop taking my current medications?

The trial requires that participants have not changed their medications for pain, anxiety, depression, or sleeplessness in the last 60 days. If you have changed these medications recently, you may need to wait until a 60-day period without changes is met before joining the trial.

Is the treatment Nu-V3 safe for humans?

The treatment NVX-CoV2373, also known as Nuvaxovid or the Novavax COVID-19 Vaccine, has been shown to have an acceptable safety profile in adults based on several clinical trials. ^{1 2 3 4 5}

Research Team

Vipul Kella, MD

Principal Investigator

Nu-Life Solutions

Eligibility Criteria

Inclusion Criteria

Participants must score greater than or equal to a 5/10 for their primary symptom score on the Baseline Symptom Questionnaire

Patient's chosen primary symptom must have an available accrual slot for the participant. If patient scores greater than or equal to a 5/10 for a second symptom, they can be selected to accrue to another symptom slot.

Participant has signed the Informed Consent Form

Exclusion Criteria

Participants with a pacemaker

Have had a transplant within the last 2 years

Participants with irregular heart rate or a heart rate lower than 60 beats per minute (bradycardia)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Baseline visit includes completion of study questionnaires and assessment of primary symptoms

1 day

1 visit (in-person)

Treatment

Participants receive the Nu-V3 cranial nerve stimulation treatment device for 24 weeks

24 weeks

Weekly visits (in-person or virtual)

Observation

Participants in the control arm undergo standard of care observation for 12 weeks

12 weeks

Crossover

Control arm participants may cross over to the treatment arm for an additional 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Nu-V3

Participant Groups

Group I: Nu-V3 treatment arm Experimental Treatment 1 Intervention

Treatment with the Nu-V3 Device.

Group II: Observation treatment arm (SOC, control) Active Control 1 Intervention

Observation following stable standard of care.

Who Is Running the Clinical Trial?

Nu-Life Solutions

Lead Sponsor

Trials

2

Recruited

100+

Findings from Research

The NVX-CoV2373 COVID-19 vaccine demonstrated high efficacy rates of 89.7-90.4% in clinical trials, indicating it is effective in preventing COVID-19 in adults aged 18 and older.

The vaccine has an acceptable safety profile, with most adverse reactions being mild to moderate, and serious adverse events occurring at similar low rates in both NVX-CoV2373 and placebo groups, suggesting it is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Smith, K., Hegazy, K., Cai, MR., et al.[2023]

A study analyzing 4,339 adverse events (AEs) associated with radium-223 from the Eudra-Vigilance database found that the most common AEs were hematological, general, and gastrointestinal disorders, with over 90% classified as serious and 8% fatal.

Older patients (over 85 years) treated with radium-223 showed a higher risk of cardiac, infectious, and metabolic disorders compared to younger patients, indicating the need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. Tema, G., Lombardo, R., Voglino, O., et al.[2021]

A total of 40,599 adverse events (AEs) were reported for enzalutamide (ENZ) and 13,562 for abiraterone (ABI) in the EudraVigilance database, with over 90% of these AEs classified as serious, indicating significant safety concerns for both treatments.

Older patients (over 65 years) treated with ABI or ENZ are at a higher risk for serious health issues, such as cardiac and infectious disorders, compared to younger patients, highlighting the need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies. De Nunzio, C., Lombardo, R., Tema, G., et al.[2021]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

A study involving 102,911 participants in Australia found that the quadrivalent inactivated influenza vaccine had a low rate of adverse events, with no significant safety concerns identified across different age groups and vaccine brands.

Children aged 6 months to 4 years reported higher rates of adverse events (8.4%) compared to older individuals, but overall, the rates of fever and medical attendance remained low and within expected levels, suggesting the vaccine is safe for the general population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia. Pillsbury, AJ., Glover, C., Jacoby, P., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Adverse events related to abiraterone and enzalutamide treatment: analysis of the EudraVigilance database and meta-analysis of registrational phase III studies. [2021]

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

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Active surveillance of 2017 seasonal influenza vaccine safety: an observational cohort study of individuals aged 6 months and older in Australia. [2019]