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Behavioural Intervention

Phase II Trial of Nu-V3 Non-Invasive Nerve Stimulation Device for Chronic Pain, Anxiety, Depression, Sleeplessness (Nu-V3P2RCT Trial)

N/A
Waitlist Available
Led By Vipul Kella, MD
Research Sponsored by Nu-Life Solutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

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.

Eligible Conditions
  • Chronic Pain
  • Depression
  • Botox
  • Insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
+2 more
Secondary study objectives
Effectiveness: Symptom Frequency
Effectiveness: Symptom Severity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nu-V3 treatment armExperimental Treatment1 Intervention
Treatment with the Nu-V3 Device.
Group II: Observation treatment arm (SOC, control)Active Control1 Intervention
Observation following stable standard of care.

Find a Location

Who is running the clinical trial?

Nu-Life SolutionsLead Sponsor
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Chronic Pain
16 Patients Enrolled for Chronic Pain
Vipul Kella, MDPrincipal InvestigatorNu-Life Solutions
Eric T. Siebeneck, MSStudy DirectorNu-Life Solutions
~29 spots leftby May 2025
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