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

NCT05394545 | Suspended DMC FDA Device

• 1 other identifier: Nu-V3 RCT Protocol
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Pain; Anxiety; Depression; Sleeplessness

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Overall safety from unanticipated problems or risks

  At screening/baseline, a medical history will be obtained to capture relevant underlying conditions. The screening/baseline examinations will include BP, and HR. Baseline signs and symptoms are those that are assessed within 14 days prior to week 1 treatment. Concomitant medications will be collected from within 14 days prior to enrollment through the study treatment period and maintenance period. The primary safety endpoint is the occurrence of reported unanticipated problems involving risk to subjects or others ("UPIRTSOs"). These UPIRTSOs are defined as those problems which alter the risks to subjects or others. This includes any study suspensions or holds. The primary safety endpoint analyses will be based on a risk-benefit conclusion.

  Week 24

• 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 (2)

Nu-V3 treatment arm

EXPERIMENTAL

Treatment with the Nu-V3 Device.

Device: Nu-V3

Observation treatment arm (SOC, control)

NO INTERVENTION

Observation following stable standard of care.

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 treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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: chronic pain, anxiety, depression, and/or sleeplessness
• Participants must score greater than or equal to a 5/10 for their primary symptom score on the Baseline Symptom Questionnaire
• Patient's chosen primary symptom must have an available accrual slot for the participant. If patient scores greater than or equal to a 5/10 for a second symptom, they can be selected to accrue to another symptom slot.
• Participant has signed the Informed Consent Form

You may not qualify if:

• Participants with a hearing aid
• 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
• 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 (2)

Greater Chicago Specialty Physicians (GCSP) - Schamuburg

Schaumburg, Illinois, 60195, United States

Location

EZ Clinic

Greenwood, Indiana, 46143, 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

• Vipul Kella, MD

  Nu-Life Solutions

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: March 20, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)