Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness (Nu-V3)
Primary Purpose
Chronic Pain, Anxiety, Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nu-V3
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Device, TENS, Neuromodulation, PTSD, Neuropathy, Inflammatory, Arthritis, Chronic Pain, Fibromyalgia, Osteoarthritis, TMJ, Insomnia
Eligibility Criteria
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
Sites / Locations
- Arizona Endocrinology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nu-V3 Device
Arm Description
Treatment with the Nu-V3 Device.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Effectiveness: Symptom Frequency
In the Nu-V3 device treatment arm, the study will report the mean time from treatment initiation to reduction of symptoms of at least 30% in any of the four domains of symptom measurement.
Effectiveness: Symptom Severity
In both the Nu-V3 device treatment arm and the observation arm, the study will report the mean percentage change in symptoms severity from initiation to 12 and 24 weeks for each instrument.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05335980
Brief Title
Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness
Acronym
Nu-V3
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
April 13, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nu-Life Solutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Anxiety, Depression, Sleeplessness
Keywords
Device, TENS, Neuromodulation, PTSD, Neuropathy, Inflammatory, Arthritis, Chronic Pain, Fibromyalgia, Osteoarthritis, TMJ, Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nu-V3 Device
Arm Type
Experimental
Arm Description
Treatment with the Nu-V3 Device.
Intervention Type
Device
Intervention Name(s)
Nu-V3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness and overall change in reported primary symptom of concern: Chronic Pain
Description
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.
Time Frame
12 and 24 weeks
Title
Effectiveness and overall change in reported primary symptom of concern: Anxiety
Description
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.
Time Frame
12 and 24 weeks
Title
Effectiveness and overall change in reported primary symptom of concern: Depression
Description
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.
Time Frame
12 and 24 weeks
Title
Effectiveness and overall change in reported primary symptom of concern: Sleeplessness
Description
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.
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Effectiveness: Symptom Frequency
Description
In the Nu-V3 device treatment arm, the study will report the mean time from treatment initiation to reduction of symptoms of at least 30% in any of the four domains of symptom measurement.
Time Frame
12 and 24 weeks
Title
Effectiveness: Symptom Severity
Description
In both the Nu-V3 device treatment arm and the observation arm, the study will report the mean percentage change in symptoms severity from initiation to 12 and 24 weeks for each instrument.
Time Frame
12 and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Doebbeling, MD
Organizational Affiliation
Nu-Life Solutions
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kamran Chaudhary, MD
Organizational Affiliation
Nu-Life Solutions
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric T Siebeneck, MS
Organizational Affiliation
Nu-Life Solutions
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Endocrinology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.nu-v3.com/
Description
Nu-Life Solutions Homepage
Learn more about this trial
Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness
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