Trigeminal Nerve Stimulation (TNS) in the Treatment of Fibromyalgia

Phase 2UnknownNCT02120690

Santa Casa Medical School40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Interventions

Trigeminal nerve stimulationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centro de Atencao Integrada à Saúde Mental

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

VAS for pain

Comparison between VAS for pain after intervention protocol and baseline score

Time frame: 10 day-follow up

Data from ClinicalTrials.gov

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