Nu-V3 Non-Invasive Nerve Stimulation Device Trial for Chronic Pain, Anxiety, Depression, Sleeplessness
TerminatedNot applicableNCT05335980
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- 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
- Conditions
- Chronic Pain
- Anxiety
- Depression
- Sleeplessness
- Interventions
- Device: Nu-V3
- Sponsor
- Nu-Life Solutions
- Start date
- 2018-04-13
- Primary completion
- 2020-07-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05335980