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Neuromodulation Device

Neuromodulation Device for Fibromyalgia

N/A
Recruiting
Research Sponsored by Theranica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient age is 18-70
Possesses the basic cognitive and motor skills needed to operate his/her own smartphone
Must not have
Known uncontrolled epilepsy
Patients with severe depression, and/or suicidality
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Summary

This trial examines a new technology called Remote Electrical Neuromodulation (REN) for treating fibromyalgia pain. REN uses non-painful signals to activate the body's pain management system

Who is the study for?
This trial is for individuals with fibromyalgia or myofascial pain syndrome, experiencing widespread body pain, tenderness, and fatigue. Participants should be seeking non-pharmacological treatment options.
What is being tested?
The study tests the FibroNova device's safety and effectiveness in treating fibromyalgia symptoms. It uses Remote Electrical Neuromodulation to potentially ease pain by activating the body's own pain management system.
What are the potential side effects?
While specific side effects are not listed, similar neuromodulation devices can cause mild skin irritation at the site of application or a temporary increase in muscle tension.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I can use my smartphone by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have epilepsy that is not controlled by medication.
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I am struggling with severe depression or thoughts of harming myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device safety (rate of adverse events and device related adverse events)
Mean reduction in pain level during the last 14 days of the treatment phase (weeks 15 through 16) compare to the last 14 days of baseline phase (weeks 3 through 4)
Secondary study objectives
Improvement in patient global impression according to PGIC score
Mean change in Brief Pain Inventory (BPI) score
Mean change in FIQR functionality sub-scale score
+3 more
Other study objectives
Improvement in quality of life
Improvement in sleep quality
Mean change in level of anxiety
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Treatment with active FibroNova deviceActive Control1 Intervention
Treatment of Fibromyalgia pain and symptoms with active FibroNova device. Participants will treat with an active device twice a day.
Group II: Treatment with Sham FibroNova devicePlacebo Group1 Intervention
Treatment of Fibromyalgia pain and symptoms with Sham FibroNova device. Participants will treat with a sham device twice a day.

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Who is running the clinical trial?

TheranicaLead Sponsor
19 Previous Clinical Trials
40,772 Total Patients Enrolled
Daniel Clauw, MDStudy ChairUniversity of Michigan
3 Previous Clinical Trials
952 Total Patients Enrolled
1 Trials studying Fibromyalgia
22 Patients Enrolled for Fibromyalgia
~77 spots leftby Mar 2025
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