Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions

NCT05540002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-03-19

Study results available
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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.

Conditions

Interventions

DEVICE

High Intensity Quell

Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.

DEVICE

Low Intensity Quell

Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.

Sponsors & Collaborators

  • NeuroMetrix, Inc.

    collaborator INDUSTRY
  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Robert N. Jamison, Ph.D. · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2024-09-19
Completion
2024-09-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540002 on ClinicalTrials.gov