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

NCT05335980 | Terminated DMC FDA Device

• 1 other identifier: Nu-V3 CPADS PROTOCOL
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Anxiety; Depression; Sleeplessness

Keywords

Device; TENS; Neuromodulation; PTSD; Neuropathy; Inflammatory; Arthritis; Chronic Pain; Fibromyalgia; Osteoarthritis; TMJ; Insomnia

Outcome Measures

Primary Outcomes (4)

• Effectiveness and overall change in reported primary symptom of concern: Chronic Pain

  Chronic Pain - (PEG Scale) The PEG is a three-item instrument that measures pain intensity (one item) and pain interference (two items). The PEG is a three-item instrument that measures pain intensity (one item) and pain interference (two items). Each item is valued from 0 (no pain/interference) to 10 (as bad as you can imagine). The instrument score is calculated as the average of the three item values.

  12 and 24 weeks

• Effectiveness and overall change in reported primary symptom of concern: Anxiety

  Anxiety - (GAD-7)The GAD-7 is a seven-item instrument that measures respondents' symptoms of anxiety. The GAD-7 is a seven-item instrument that measures respondents' symptoms of anxiety. Each item is scored on a four-point Likert scale, and values range from 0 ("Not at all") to 3 ("Nearly every day".) Items are summed to determine the instrument's score. Values of 10 or higher have been associated with moderate anxiety, while values of 15 or higher have been associated with severe anxiety.

  12 and 24 weeks

• Effectiveness and overall change in reported primary symptom of concern: Depression

  Depression - (PHQ-9) The PHQ-9 is a nine-item instrument that measures depression-related symptoms and functional impairment. The PHQ-9 is a nine-item instrument that measures depression-related symptoms and functional impairment. Each item is scored on a four-point Likert scale and values range from 0 ("Not bothered at all") to 3 ("Bothered nearly every day.") The items' values are summed to determine the instrument's score. PHQ-9 values of 10 and 15 represent moderate and moderately severe depression respectively.

  12 and 24 weeks

• Effectiveness and overall change in reported primary symptom of concern: Sleeplessness

  Sleeplessness - PROMIS short form 4a- This eight item instrument measures sleep disturbance and sleep-related impairment. This eight item instrument measures sleep disturbance and sleep-related impairment.

  12 and 24 weeks

Secondary Outcomes (2)

• Effectiveness: Symptom Frequency

  12 and 24 weeks

• Effectiveness: Symptom Severity

  12 and 24 weeks

Study Arms (1)

Nu-V3 Device

EXPERIMENTAL

Treatment with the Nu-V3 Device.

Device: Nu-V3

Interventions

Nu-V3 DEVICE

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.

Nu-V3 Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nu-Life Solutions: lead

Study Sites (1)

Arizona Endocrinology

Phoenix, Arizona, 85053, United States

Location

Related Links

• Nu-Life Solutions Homepage

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders; Depression; Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Arthritis; Fibromyalgia; Osteoarthritis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases

Study Officials

• Bradley Doebbeling, MD

  Nu-Life Solutions

  STUDY CHAIR

• Kamran Chaudhary, MD

  Nu-Life Solutions

  PRINCIPAL INVESTIGATOR

• Eric T Siebeneck, MS

  Nu-Life Solutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase II 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

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 20, 2022
• Study Start: April 13, 2018
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)