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

NCT05394545 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-07-28

No results posted yet for this study

Summary

This Nu-V3 clinical study is a randomized, phase II, open-label study evaluating the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness.

Conditions

Interventions

DEVICE

Nu-V3

The Nu-V3 device provides a continuous flow of intermittent, low frequency electrical pulses to the ear's specific cranial nerve endings. This treatment is delivered 24 hours a day for the first 12 weeks, then is delivered two weeks on, one week off for the following 12 weeks.

Sponsors & Collaborators

  • Nu-Life Solutions

    lead INDUSTRY

Principal Investigators

  • Vipul Kella, MD · Nu-Life Solutions

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-05-31
Completion
2025-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05394545 on ClinicalTrials.gov