NSS-2 BRIDGE device for Cancer Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh Medical Center - Shadyside Hospital, Pittsburgh, PA
Cancer Pain+5 More
NSS-2 BRIDGE - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is a study to test whether a device that stimulates the nerves of the ear can reduce postoperative pain and the need for opioids. The NSS-2 BRIDGE device is a small, wearable device that is placed behind the ear. It is used to deliver low levels of electrical stimulation to the trigeminal nerve, which is responsible for carrying pain signals from the face to the brain. The device is used to treat cancer pain, and has been shown to be effective in reducing pain intensity and increasing quality of life in cancer patients.

Eligible Conditions

  • Cancer Pain
  • Auriculotherapy
  • Opioids Use
  • Pain, Abdominal

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 19 Secondary · Reporting Duration: Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative

Day 1
Post-operative nausea and vomiting rating
Month 3
Area under the curve of post-operative pain rating using a numerical rating scale
Post-operative pain rating using a numerical rating scale
Baseline, pre-surgery
Pre-operative Brief Symptom Index Somatization Scale
Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to depression
Pre-operative pain rating using the Pain Catastrophizing Scale
Pre-operative sleep disturbance
Month 3
Change in post-operative pain rating using the Pain Catastrophizing Scale
Change in the Brief Symptom Index Somatization Scale
Post-operative change in emotional distress related to anxiety
Post-operative change in emotional distress related to depression
Post-operative change in sleep disturbance
Day 30
Overall Patient Satisfaction
Day 30
Length of hospital stay
Day 5
Time to Ambulation
Time to Oral Intake
Time to discharge from the recovery unit
Day 5
Opioid Consumption
Hour 120
Device tolerability

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

NSS-2 BRIDGE device
1 of 2
Placebo Bridge
1 of 2
Active Control
Non-Treatment Group

286 Total Participants · 2 Treatment Groups

Primary Treatment: NSS-2 BRIDGE device · Has Placebo Group · N/A

NSS-2 BRIDGE device
Device
ActiveComparator Group · 1 Intervention: NSS-2 BRIDGE · Intervention Types: Device
Placebo Bridge
Device
ShamComparator Group · 1 Intervention: Sham NSS-2 BRIDGE · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative
Closest Location: University of Pittsburgh Medical Center - Shadyside Hospital · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
2014First Recorded Clinical Trial
1 TrialsResearching Cancer Pain
2 CompletedClinical Trials

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,393 Previous Clinical Trials
24,523,684 Total Patients Enrolled
Masimo CorporationIndustry Sponsor
93 Previous Clinical Trials
10,882 Total Patients Enrolled
Jacques E. ChellyLead Sponsor
8 Previous Clinical Trials
403 Total Patients Enrolled
Jacques E Chelly, MD, PhD, MBAPrincipal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
101 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are over 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.