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

Studies

Study First Submitted Date 2022-05-24
Study First Posted Date 2022-05-27
Last Update Posted Date 2023-07-28
Start Month Year March 20, 2024
Primary Completion Month Year May 31, 2025
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-28

Detailed Descriptions

Sequence: 20849365
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.

Facilities

Sequence: 201264308 Sequence: 201264309
Name Greater Chicago Specialty Physicians (GCSP) – Schamuburg Name EZ Clinic
City Schaumburg City Greenwood
State Illinois State Indiana
Zip 60195 Zip 46143
Country United States Country United States

Conditions

Sequence: 52499597 Sequence: 52499598 Sequence: 52499599 Sequence: 52499600
Name Chronic Pain Name Anxiety Name Depression Name Sleeplessness
Downcase Name chronic pain Downcase Name anxiety Downcase Name depression Downcase Name sleeplessness

Id Information

Sequence: 40393441
Id Source org_study_id
Id Value Nu-V3 RCT Protocol

Countries

Sequence: 42829413
Name United States
Removed False

Design Groups

Sequence: 55955701 Sequence: 55955702
Group Type Experimental Group Type No Intervention
Title Nu-V3 treatment arm Title Observation treatment arm (SOC, control)
Description Treatment with the Nu-V3 Device. Description Observation following stable standard of care.

Interventions

Sequence: 52807738
Intervention Type Device
Name Nu-V3
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.

Keywords

Sequence: 80313939 Sequence: 80313940 Sequence: 80313941 Sequence: 80313942 Sequence: 80313943 Sequence: 80313944 Sequence: 80313945 Sequence: 80313946 Sequence: 80313947 Sequence: 80313948 Sequence: 80313949 Sequence: 80313950
Name Device Name TENS Name Neuromodulation Name PTSD Name Neuropathy Name Inflammatory Name Arthritis Name Chronic Pain Name Fibromyalgia Name Osteoarthritis Name TMJ Name Insomnia
Downcase Name device Downcase Name tens Downcase Name neuromodulation Downcase Name ptsd Downcase Name neuropathy Downcase Name inflammatory Downcase Name arthritis Downcase Name chronic pain Downcase Name fibromyalgia Downcase Name osteoarthritis Downcase Name tmj Downcase Name insomnia

Design Outcomes

Sequence: 178605538 Sequence: 178605539 Sequence: 178605540 Sequence: 178605541 Sequence: 178605542 Sequence: 178605543 Sequence: 178605544
Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary
Measure Overall safety from unanticipated problems or risks Measure Effectiveness and overall change in reported primary symptom of concern: Chronic Pain Measure Effectiveness and overall change in reported primary symptom of concern: Anxiety Measure Effectiveness and overall change in reported primary symptom of concern: Depression Measure Effectiveness and overall change in reported primary symptom of concern: Sleeplessness Measure Effectiveness: Symptom Frequency Measure Effectiveness: Symptom Severity
Time Frame Week 24 Time Frame 12 and 24 weeks Time Frame 12 and 24 weeks Time Frame 12 and 24 weeks Time Frame 12 and 24 weeks Time Frame 12 and 24 weeks Time Frame 12 and 24 weeks
Description 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. 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. 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. 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. 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. 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. 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.

Browse Conditions

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Mesh Term Sleep Initiation and Maintenance Disorders Mesh Term Chronic Pain Mesh Term Depression Mesh Term Depressive Disorder Mesh Term Anxiety Disorders Mesh Term Behavioral Symptoms Mesh Term Mood Disorders Mesh Term Mental Disorders Mesh Term Pain Mesh Term Neurologic Manifestations Mesh Term Sleep Disorders, Intrinsic Mesh Term Dyssomnias Mesh Term Sleep Wake Disorders Mesh Term Nervous System Diseases
Downcase Mesh Term sleep initiation and maintenance disorders Downcase Mesh Term chronic pain Downcase Mesh Term depression Downcase Mesh Term depressive disorder Downcase Mesh Term anxiety disorders Downcase Mesh Term behavioral symptoms Downcase Mesh Term mood disorders Downcase Mesh Term mental disorders Downcase Mesh Term pain Downcase Mesh Term neurologic manifestations Downcase Mesh Term sleep disorders, intrinsic Downcase Mesh Term dyssomnias Downcase Mesh Term sleep wake disorders Downcase Mesh Term nervous system diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48623653
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Nu-Life Solutions

Overall Officials

Sequence: 29456766
Role Principal Investigator
Name Vipul Kella, MD
Affiliation Nu-Life Solutions

Design Group Interventions

Sequence: 68596620
Design Group Id 55955701
Intervention Id 52807738

Eligibilities

Sequence: 30952797
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: 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 Exclusion Criteria: 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 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 253877496
Number Of Facilities 2
Registered In Calendar Year 2022
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 5
Number Of Secondary Outcomes To Measure 2

Designs

Sequence: 30698381
Allocation Randomized
Intervention Model Crossover Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)
Intervention Model Description 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

Links

Sequence: 4413116
Url https://www.nu-v3.com/
Description Nu-Life Solutions Homepage

Provided Documents

Sequence: 2602298 Sequence: 2602299
Document Type Study Protocol Document Type Informed Consent Form
Has Protocol True Has Protocol False
Has Icf False Has Icf True
Has Sap False Has Sap False
Document Date 2022-05-19 Document Date 2022-05-19
Url https://ClinicalTrials.gov/ProvidedDocs/45/NCT05394545/Prot_000.pdf Url https://ClinicalTrials.gov/ProvidedDocs/45/NCT05394545/ICF_001.pdf

Responsible Parties

Sequence: 29065143
Responsible Party Type Sponsor