Effects of Neuro-Stim System on Pain, Sleep, and Opioid Use

NCT02673684 | Terminated Results FDA Device

• 1 other identifier: 390805
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.

Conditions

Pain (Visceral, Somatic, or Neuropathic)

Outcome Measures

Primary Outcomes (1)

• Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS)

  The primary outcome is pain measured by the Defense and Veterans Pain Rating Scale (DVPRS) from 0-10 at baseline, 15 minutes, and daily for 5 days after application. Rate the severity of your CURRENT pain: 0 - No Pain 1. \- Hardly notice pain 2. \- Notice pain, does not interfere with activities 3. \- Sometimes distracts me 4. \- Distracts me, can do usual activities 5. \- Interrupts some activities 6. \- Hard to ignore, avoid usual activities 7. \- Focus of attention, prevents doing daily activities 8. \- Awful, hard to do anything 9. \- Can't bear pain, unable to do anything 10. \- As bad as it could be, nothing else matters Higher values represent worse outcomes

  baseline to 5 days

Secondary Outcomes (1)

• Modified PROMIS for Pain Intensity

  baseline to 10 days

Other Outcomes (2)

• Modified PROMIS for Pain Interference

  baseline to 10 days

• Modified PROMIS for Sleep Disturbance

  baseline to 10 days

Study Arms (2)

Sham Neurostim System (Sham NSS)

SHAM COMPARATOR

In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device.

Device: Sham NSS

Working Neurostim System (Working NSS)

EXPERIMENTAL

In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.

Device: Experimental NSS

Interventions

Experimental NSS DEVICE

5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.

Also known as: Electro Auricular Device

Working Neurostim System (Working NSS)

Sham NSS DEVICE

(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.

Sham Neurostim System (Sham NSS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be inpatients (at Walter Reed National Military Medical Center) at the time of study enrollment and study device placement.
• Any patient experiencing post-operative pain (visceral, somatic, or neuropathic) and has a pain score (measured via DVPRS v2.0) equal to or greater than 4 for at least 3 hours in the past 24 hours.
• Has an intact external ear where device can be placed
• The skin of the ear at placement site must be free of infection
• The participant cannot have been on regularly scheduled central acting opioids for more than 30 days continuously leading up to the initiation of the study. However, intermittent, breakthrough opioids are permissible, but the potential subject must have a current opioid prescription.
• The participant must have vital signs (HR/breathing/blood pressure) within normal limits.
• Able to understand English and verbalize their pain level.

You may not qualify if:

• Have inconsistent vital signs (fluctuating, extremely low blood pressure, tachycardia, etc.)
• Wear any time of implanted electrical device such as a brain shunt, vagal stimulator, pace maker, spinal pain pump, etc.
• Pregnant (by results of preoperative Human Chorionic Gonadotropin or hCG urine or blood testing)
• Has a history of skin allergy to metals
• unwilling to voluntarily participate
• hemophilia
• Psoriasis vulgaris on ears

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead
• Innovative Health Solutions: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Lost funding in the early stages of the project which ended recruitment to the study.

Results Point of Contact

• Title: Mary McDuffie
• Organization: Defense and Veterans Center for Integrative Pain Management

mmcduffie@dvcipm.org

301-400-4242

Study Officials

• Chester Buckenmaier, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 27, 2020
• Results First Posted: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)