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

Depression Clinical Trial

Official title: 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

Status Suspended

Clinical Trial 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.

Clinical Trial Description

Subjects randomized to receive the Nu-V3 treatment will undergo the following regimen:

• At the baseline visit, patients will be asked to complete study questionnaires regarding all of the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their quality of life, active medications, medical history, and demographical information. The subject's primary symptom of concern will also be notated at baseline, for later assessment of continuation after week 12.

• At each subsequent visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their activity level and quality of life.

• The sessions will begin with the Nu-V3 device being clipped on the ear and three small pads (non-invasive) adhered to the surface of the ear. Each Nu-V3 device lasts for up to 28 days with a change in the pads approximately 7 days into the treatment.

• Each session takes approximately 15-20 minutes. The placement of the device takes approximately 5 minutes, and the remaining time is spent verifying ePRO form completion, and evaluating the patient for all device effects.

• The Nu-V3 device is mobile and is worn externally on the left ear 24 hours a day during treatment, fitting comfortably behind the ear. An electrical signal is sent to the external ear through coated wire leads attached to the device and adhesive pads which attach to three sites on the ear.

• Participants should be able to perform their typical day-to-day activities while wearing the device. They may shower while wearing the Nu-V3 device, if they do not get the device wet and use the small disposable ear covers that are provided for them.

• In the event the Nu-V3 gel pads are inadvertently removed or the device comes off, the participant will contact the site coordinator. The participant is encouraged to adjust the device placement as needed for comfort.

• Patients should not change their existing forms of treatment or medications without discussion with the study investigator.

Subjects randomized to the observation control arm of the study will undergo the following regimen:

• At the baseline visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their quality of life, active medications, medical history, and demographical information. The subject's primary symptom of concern will also be notated at baseline.

• At each subsequent visit, patients will be asked to complete study questionnaires regarding all the following symptoms: chronic pain, anxiety, depression, and/or sleeplessness, as well as their activity level and quality of life.

• Patients should not change their existing forms of treatment or medications without discussion with the study investigator.

• At completion of 12 weeks of standard of care treatment post study enrollment, observation (control arm) subjects will be offered a crossover into the treatment arm of the study for an additional 24 weeks.

Sample size For this Phase II study, a total of 100-200 subjects will be randomized 1:1 to either the Nu-V3 treatment arm or to the observation treatment arm (SOC, control).

Recruitment Participants are enrolled into relevant symptom cohorts based on their chronic pain, anxiety, depression, and/or sleeplessness symptom presentation at baseline and treated with the Nu-V3 device for 24 weeks.

Analyses Interim analysis of reported data will be based on baseline symptom cohort and conducted at 6, 12, 18, and 24 weeks during this time. The participant will be evaluated after the initial 12-week treatment period to assess for further therapeutic need. Upon having three consecutive weeks of mean symptom reduction of ≥70% via patient reported numerical scales, the participant will continue as described in the study assessments table, but without device therapy. Then if the participant's primary symptom score increases at any time by ≥20%, they may again continue device therapy until week 24, as depicted in section 4.1.

Study subjects randomized to the observation arm will be offered the opportunity to cross-over to the Nu-V3 study treatment arm upon completion of the initial 12-week observation study period. ;

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Chronic Pain
• Depression
• Depressive Disorder
• Sleep Initiation and Maintenance Disorders
• Sleeplessness

• NCT number: NCT05394545
• Study type: Interventional
• Source: Nu-Life Solutions
• Status: Suspended
• Phase: N/A
• Start date: March 20, 2024
• Completion date: May 31, 2025