Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness
Stopped early · Not applicable
Conditions studied: Chronic Pain, Anxiety, Depression, Sleeplessness
In brief
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.
Key facts
- Study ID
- NCT05335980
- Run by
- Nu-Life Solutions
- People needed
- 16
- Starts
- 2018-04-13
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2022-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Arizona Endocrinology — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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