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

Nu-Life Solutions

Status

Terminated

Conditions

Sleeplessness

Chronic Pain

Depression

Anxiety

Treatments

Device: Nu-V3

Study type

Interventional

Funder types

Industry

Identifiers

NCT05335980

Nu-V3 CPADS PROTOCOL

Details and patient eligibility

About

The Nu-V3 Clinical Study is a prospective, single-arm, open-label, multi-center study using the Nu-V3 cranial nerve stimulation treatment device in patients with chronic pain, anxiety, depression, and/or sleeplessness.

For this Phase II study, a total of 100-200 patients at multiple centers will be registered for study participation. Study participants are those who have signed the informed consent form, met the inclusion and exclusion criteria, and are enrolled in the study at one of multiple sites. Enrolled participants are stratified based on their chronic pain, anxiety, depression, and/or sleeplessness symptom presentation at baseline and treated with the Nu-V3 device for 24 weeks. Interim analysis of reported data will be based on baseline stratifications 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.

Full description

Subjects enrolled onto the Nu-V3 Clinical Trial 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 demographic 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 14 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, provided that 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant is at least 18 years of age
Participant presents with one or more of the following symptoms: pain, depression, anxiety, and/or sleeplessness
Participant is capable of understanding the use and maintenance of the device
Participant is capable and agreeing to participate in the ongoing assessment
Participant has signed the Informed Consent Form
Participant can commit to follow all protocol study timepoints

Exclusion criteria

Participants with a Pacemaker
Participants with irregular heart rate or a heart rate lower than 60 beats per minute (bradycardia)
Have had a transplant within the last 2 years
Have had a heart attack or cardiac bypass surgery within the last 12 months
History of substance abuse, including prescription drugs, within the last 12 months
Patients with complaints of dizziness or lightheadedness within the last 3 months
Women who are pregnant
Participants with Diabetic Retinopathy
Current Ear infection
SBP < 100 and/or DBP < 60
History of uncontrolled bipolar disorder within the last 12 months
History of uncontrolled seizures within the last 12 months
History of Aneurysms
History of syncope within the last 12 months
Participants that have had a TIA or stroke within the last 12 months
Participants with health problems deemed at risk for the study by the Principal Investigator
Participants with any changes to Pain/Anxiety/Depression/Sleeplessness medications within last 60 days (participants that do not meet this medication- change washout period may be delayed until 60-day period is met)
Participants that are currently under adjudication process for disability support, VA or other