Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Study Overview
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Brief Summary
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To the investigators knowledge there are no studies of Trigeminal Nerve Stimulation (TNS) for fibromyalgia. TNS may modify overlapping mood and fibromyalgia pain regulation circuitry. The investigators hypothesized that patients with fibromyalgia might experience a clinically significant reduction in daily pain if investigators were to administer TNS in a manner similar to experimental antidepressant protocols.

Official Title
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Trigeminal Nerve Stimulation (TNS) as a Complementary Strategy in the Treatment of Fibromyalgia, Open Label Study

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Trigeminal nerve stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We will adopt the following inclusion criteria: (1) patients between 18 and 69 years; (2) patients with a diagnosis of fibromyalgia according to a trained phisycian; (3) score greater than or equal to 5 on the VAS for pain; (4) agreement to participate in the study as recommended in the IC. Exclusion Criteria: Exclusion criteria we cite: (1) patients with psychiatric hospitalization indicated; (2) patients with psychiatric comorbidity; (3) patients with a diagnosis of personality disorder; (4) presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic decompensated.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trigeminal nerve stimulation - active<br>10-day TNS interventional protocol over an 10-day follow-up | Device: Trigeminal nerve stimulation<br>* 10-day TNS interventional protocol over an 10-day follow-up. Subjects will have electrodes (Superior Silver 1.25-in. diameter) placed on their foreheads to stimulate the V1 branches of the trigeminal nerve bilaterally for approximately 30 minutes each day. Current was adjusted to maintain comfortable but perceptible levels of stimulation<br>|
| Sham Comparator: Trigeminal nerve stimulation<br>10-day sham interventional protocol over an 10-day follow-up | Device: Trigeminal nerve stimulation<br>* 10-day TNS interventional protocol over an 10-day follow-up. Subjects will have electrodes (Superior Silver 1.25-in. diameter) placed on their foreheads to stimulate the V1 branches of the trigeminal nerve bilaterally for approximately 30 minutes each day. Current was adjusted to maintain comfortable but perceptible levels of stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS for pain | Comparison between VAS for pain after intervention protocol and baseline score | 10 day-follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, fibromyagia, TNS