Nu-V3 for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
EZ Clinic, Greenwood, IN
Depression+6 More
Nu-V3 - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Depression
  • Anxiety
  • Chronic Pain
  • Insomnia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 2 Secondary · Reporting Duration: 12 and 24 weeks

12 and 24 weeks
Effectiveness and overall change in reported primary symptom of concern: Anxiety
Effectiveness and overall change in reported primary symptom of concern: Chronic Pain
Effectiveness and overall change in reported primary symptom of concern: Depression
Effectiveness and overall change in reported primary symptom of concern: Sleeplessness
Effectiveness: Symptom Frequency
Effectiveness: Symptom Severity
Week 24
Overall safety from unanticipated problems or risks

Trial Safety

Trial Design

2 Treatment Groups

Observation treatment arm (SOC, control)
1 of 2
Nu-V3 treatment arm
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Nu-V3 · No Placebo Group · N/A

Nu-V3 treatment arm
Device
Experimental Group · 1 Intervention: Nu-V3 · Intervention Types: Device
Observation treatment arm (SOC, control)NoIntervention Group · 1 Intervention: Observation treatment arm (SOC, control) · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 and 24 weeks
Closest Location: EZ Clinic · Greenwood, IN
Photo of indiana 1Photo of indiana 2Photo of indiana 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Depression
0 CompletedClinical Trials

Who is running the clinical trial?

Nu-Life SolutionsLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Depression
16 Patients Enrolled for Depression
Vipul Kella, MDPrincipal InvestigatorNu-Life Solutions
Eric T. Siebeneck, MSStudy DirectorNu-Life Solutions

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age.
You have one or more of the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness.
Patient must have a primary symptom that is eligible for accrual

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.