High Intensity Stimulation for Hypersensitivity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital Pain Management Center, Chestnut Hill, MA
Hypersensitivity+4 More
High Intensity Quell - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.

Eligible Conditions

  • Hypersensitivity
  • Chronic Pain
  • Pain
  • Adults 21 and Older

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 3-month Follow-up

3-month Follow-up
Satisfaction and Qualitative Questions
Changes from Baseline to 3-month Follow-Up
Healthcare Utilization
Hospital Anxiety and Depression Scale (HADS)
Pain Catastrophizing Scale (PCS)
Pain Detect Neuropathic Pain Questionnaire (painDETECT)
Pain Disability Index (PDI)
Patient's Global Impression of Change (PGIC)
Quantitative Sensory Testing (QST)
Symptom Impact Questionnaire (SIQR)
The Brief Pain Inventory Interference Scale (BPI)
The Brief Pain Inventory Pain Intensity Scale
Daily ratings over 3-months
MasterMyPain App

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

High Intensity Stimulation
1 of 2
Low Intensity Stimulation
1 of 2
Active Control
Non-Treatment Group

115 Total Participants · 2 Treatment Groups

Primary Treatment: High Intensity Stimulation · Has Placebo Group · N/A

Low Intensity Stimulation
Device
ShamComparator Group · 1 Intervention: Low Intensity Quell · Intervention Types: Device
High Intensity Stimulation
Device
ActiveComparator Group · 1 Intervention: High Intensity Quell · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-month follow-up
Closest Location: Brigham and Women's Hospital Pain Management Center · Chestnut Hill, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
2011First Recorded Clinical Trial
1 TrialsResearching Hypersensitivity
2 CompletedClinical Trials

Who is running the clinical trial?

NeuroMetrix, Inc.Industry Sponsor
5 Previous Clinical Trials
295 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,453 Previous Clinical Trials
9,701,129 Total Patients Enrolled
4 Trials studying Hypersensitivity
206 Patients Enrolled for Hypersensitivity
Robert N. Jamison, Ph.D.Principal InvestigatorBrigham and Women's Hospital

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a pain rating of at least 4 on a scale of 0 to 10.
Pain is not accounted for by any other progressive disease (e.g., cancer, MS).
Meets the criterion for sensory hypersensitivity.
You are able to speak and understand English.\n

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.