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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 weeks

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